scholarly journals The efficacy of N-Acetylcysteine in severe COVID-19 patients: A structured summary of a study protocol for a randomised controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Arash Rahimi ◽  
Hamid Reza Samimagham ◽  
Mehdi Hassani Azad ◽  
Dariush Hooshyar ◽  
Mohsen Arabi ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Intensive Care Unit ◽  
Intensive Care ◽  
Pharmaceutical Company ◽  
Study Protocol ◽  
Intervention Group ◽  
Phase Iii ◽  
Arterial Oxygen ◽  
Control Group ◽  
Full Protocol

Abstract Objectives Severe acute respiratory infection (SARI) caused by the SARS-CoV-2 virus may cause lung failure and the need for mechanical ventilation. Infection with SARS-COV-2 can lead to activation of inflammatory factors, increased reactive oxygen species, and cell damage. In addition to mucolytic effects, N-Acetylcysteine has antioxidant effects that we believe can help patients recover. In this study, we evaluate the efficacy of N-Acetylcysteine in patients with severe COVID-19. Trial design This is a prospective, randomized, single-blinded, phase 3 controlled clinical trial with two arms (ratio 1:1) parallel-group design of 40 patients, using the placebo in the control group. Participants All severe COVID-19 patients with at least one of the following five conditions: (respiration rate > 30 per minute), hypoxemia (O2 ≤ saturation, arterial oxygen partial pressure ratio <300), pulmonary infiltration (> 50% of lung area during 24 48 h), Lactate dehydrogenase (LDH) > 245 U / l, Progressive lymphopenia, and admitted to the intensive care unit of Shahid Mohammadi Hospital in Bandar Abbas and have positive PCR test results for SARS-Cov-2 and sign the written consent of the study will be included. Patients will be excluded from the study if they have a history of hypersensitivity to N-Acetylcysteine, pregnancy, or refuse to participate in the study. Intervention and comparator After randomization, participants in the intervention group receive standard of care (SOC) according to the National Committee of COVID-19 plus N-acetylcysteine (EXI-NACE 200mg/mL, in 10mL ampules of saline for parenteral injection (EXIR pharmaceutical company)) at a dose of 300 mg/kg equivalent to 20 gr as a slow single intravenous injection on the first day of hospitalization. In the control group patients receive SOC and placebo ( Sterile water for injection as the same dose). The placebo is identical in appearance to the N-acetylcysteine injection (EXIR pharmaceutical company as well). Main outcomes The primary endpoint for this study is a composite endpoint for the length of hospitalization in the intensive care unit and the patient's clinical condition. These outcomes were measured at the baseline (before the intervention) and on the 14th day after the intervention or on the discharge day. Randomisation Eligible participants (40) will be randomized in two arms in the ratio of 1: 1 (20 per arm) using online web-based tools and by permuted block randomization method. To ensure randomization concealment, random sequence codes are assigned to patients by the treatment team at the time of admission without knowing that each code is in the intervention or comparator group. Blinding (masking) All participants will be informed about participating in the study and the possible side effects of medication and placebo. Patients participating in the study will not be aware of the assignment to the intervention or control group. The principal investigator, health care personnel, data collectors, and those evaluating the outcome are aware of patient grouping. Numbers to be randomised (sample size) A total of 40 patients participate in this study, which are randomly divided; 20 patients in the intervention group will receive SOC and N-acetylcysteine, 20 patients in the control group will receive SOC and placebo. Trial status First version of the protocol was approved by the Deputy of Research and Technology and the ethics committee of Hormozgan University of Medical Sciences on February 14, 2021, with the local code 990573, and the recruitment started on March 2, 2021 and the expected recruitment end date is April 1, 2021. Trial registration The protocol was registered before starting participant recruitment entitled: Evaluation of the efficacy of N-Acetylcysteine in severe COVID-19 patients: a randomized controlled phase III clinical trial, IRCT20200509047364N3, at Iranian Registry of clinical trials on 20 February 2021. Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).

Effect of Nebulized Eucalyptus for Preventing Ventilator-Associated Pneumonia in Patients under Mechanical Ventilation: A Randomized Double Blind Clinical Trial

2018 ◽  
Author(s):  
HasanAli Karimpour ◽  
Behzad Hematpour ◽  
Saeed Mohammadi ◽  
Javad Aminisaman ◽  
Maryam Mirzaei ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Intensive Care Unit ◽  
Intensive Care ◽  
Intervention Group ◽  
Control Group ◽  
Pulmonary Infections ◽  
Double Blind ◽  
Double Blind Clinical Trial ◽  
And Control ◽  
And Staphylococcus Aureus

Abstract Background: Pneumonia caused by the ventilator is the most common acquired infection in the intensive care unit, which increases the morbidity and mortality of the patients. Eucalyptus plant has antiseptic properties. Therefore, the present study investigates the effect of eucalyptus incense on prevention of pneumonia in patients with endotracheal tube in the intensive care unit. Methods: This clinical trial study was performed on 100 patients under ventilation in two intervention and control groups in Imam Reza Hospital, Kermanshah, Iran in 2018. The patients in the intervention group, Eucalyptus solution 2% and in the control group received 10 cc distilled water as an inhaler three times a day. The results of the two groups were compared to the incidence of pulmonary infections based on CPIS criteria and compared with SPSS version 19 software. Results: The incidence of late pneumonia was significantly lower in the intervention group (P=0.02). The onset of pneumonia significantly later in the intervention group than the control group (P=0.01). The prevalence of Klebsiella, Candida albicans, and Staphylococcus aureus was significantly decreased in the intervention group (P=0.02) (P=0.04) (P=0.01). Conclusion: The results of this study showed that eucalyptus inhalation is effective in reducing the incidence of pulmonary infection in patients under ventilation. It is recommended that these products be used to prevent pulmonary infections in these patients.

scholarly journals Evaluation of the effect of melatonin in patients with COVID-19-induced pneumonia admitted to the Intensive Care Unit: A structured summary of a study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Ali Ameri ◽  
Masoomeh Frouz Asadi ◽  
Manoochehr Kamali ◽  
Majid Vatankhah ◽  
Ava Ziaei ◽  
...  
Keyword(s):  
Intensive Care Unit ◽  
Mechanical Ventilation ◽  
Intensive Care ◽  
Standard Treatment ◽  
Clinical Symptoms ◽  
Intervention Group ◽  
Control Group ◽  
Open Label ◽  
Full Protocol ◽  
Bandar Abbas

Abstract Objectives We investigate the effects of melatonin, compared to the usual therapeutic regimen on clinical symptoms and laboratory signs in severely ill patients with confirmed COVID-19 who are admitted to the Intensive Care Unit (ICU). Trial design This is a single-center, open-label, randomized, clinical trial with a parallel-group design. This study is being conducted at Shahid Mohammadi Hospital, Bandar Abbas, Iran. Participants All patients admitted to the ICU of Shahid Mohammadi Hospital, Bandar Abbas, Iran, will be screened for the following criteria. Inclusion criteria 1. Age >20 years 2. Definitive diagnosis of COVID-19 based on RT-PCR or/and serological testing 3. Severe pneumonia and lung involvement in imaging 4. Signing informed consent Exclusion criteria 1. Underlying diseases, including convulsive disorders, chronic hepatic and renal diseases 2. Use of mechanical ventilation 3. History of known allergy to Melatonin 4. Pregnancy and breastfeeding Intervention and Comparator Intervention group: The standard treatment regimen for COVID-19, according to the Iranian Ministry of Health and Medical Education’s protocol, along with Melatonin soft gelatin capsule (Danna Pharmaceutical Company) at a dose of 5 mg twice a day for a period of seven days. Control group: The standard treatment for COVID-19 based on the Iranian Ministry of Health and Medical Education’s protocol for a period of seven days. Main outcomes The primary outcomes are the recovery rate of clinical symptoms and checking arterial blood gas (ABG), C-reactive protein (C-RP), Ferritin, Lactate dehydrogenase (LDH) within seven days of randomization. The secondary outcomes are time to improvement of clinical and paraclinical features and length of stay in the ICU, need for mechanical ventilation, and mortality rate within seven days of randomization. Randomization Included patients will be allocated to one of the study arms using block randomization in a 1:1 ratio (each block consists of 6 patients). This randomization method ensures a balanced allocation between the arms during the study. A web-based system will generate random numbers for the allocation sequence and concealment of participants. Each number relates to one of the study arms. Blinding (masking) This is an open-label trial without blinding and placebo control. Numbers to be randomized (sample size) A total of 60 participants randomizes (30 patients allocated to the intervention group and 30 patients allocated to the control group). Trial Status The protocol is Version 1.0, February 16, 2021. Recruitment began February 28, 2021, and is anticipated to be completed by July 31, 2021. Trial registration The trial protocol has been registered in the Iranian Registry of Clinical Trials (IRCT). The registration number is “IRCT20200506047323N7”. The registration date was February 16, 2021. Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest of expediting the dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

scholarly journals The Effect of Music Therapy on Perceived Pain, Mental Health, Vital Signs, and Medication Usage of Burn Patients Hospitalized in the Intensive Care Unit: A Randomized Controlled Feasibility Study Protocol

2021 ◽  
Vol 12 ◽  
Author(s):  
Mark Ettenberger ◽  
Rafael Maya ◽  
Andrés Salgado-Vasco ◽  
Sofia Monsalve-Duarte ◽  
William Betancourt-Zapata ◽  
...  
Keyword(s):  
Intensive Care Unit ◽  
Clinical Trials ◽  
Intensive Care ◽  
Music Therapy ◽  
Study Protocol ◽  
Intervention Group ◽  
Vital Signs ◽  
Control Group ◽  
Burn Patients ◽  
Randomized Controlled

Background: Burn patients experience major physiological and psychological stressors during treatment and rehabilitation, including elevated levels of pain, anxiety, stress, or depression. Music interventions inclusive of music therapy (MT) have been shown to improve such symptoms, but rigorous clinical trials investigating specific music therapy methods in adult burn patients are scarce.Methods: This is a single center Randomized Controlled Trial (RCT) protocol with two parallel arms. Participants are 81 adult burn patients admitted to the Intensive Care Unit (ICU) of the University Hospital Fundación Santa Fe de Bogotá in Colombia. The intervention consists of a Music Assisted Relaxation (MAR) protocol, a music therapy technique composed of entrained live music combined with a guided relaxation and/or the use of imagery. The effects of the MAR will be compared to a control group (treatment as usual) over a period of maximum 2 weeks or six interventions. The primary outcome measure is perceived background pain, as measured with a Visual Analog Scale (VAS) before and after each intervention. Secondary outcomes are anxiety and depression levels; vital signs; and the use of pain medication. Additionally, some patients in the intervention group will be invited to participate in electroencephalography, electromyography, and electrocardiography recordings during the MAR.Discussion: This study protocol follows the SPIRIT guidelines for defining items of clinical trials and is the first study in Colombia to evaluate the effects of music therapy for adult burn patients. With this RCT it is hoped to gather new knowledge about the potential of music therapy to help critical care patients cope and recover from their injuries during the hospitalization in the ICU.Trial registration:www.clinicaltrials.gov, Identifier: NCT04571255.Protocol version: V1.0, May 24th 2021

scholarly journals The effect of rosemary ointment on the pressure ulcer healing in patients admitted to the intensive care unit: A randomized clinical trial

2021 ◽  
Author(s):  
Fatemeh Khoshoei Parizi ◽  
Tabandeh Sadeghi ◽  
Shahin Heidari
Keyword(s):  
Clinical Trial ◽  
Intensive Care Unit ◽  
Intensive Care ◽  
Pressure Ulcer ◽  
Ulcer Healing ◽  
Pressure Ulcers ◽  
Intervention Group ◽  
Well Being ◽  
Control Group ◽  
Significant Difference

Background & Aim: Pressure ulcers have been identified as one of the most important and challenging issues in patient’s well-being. Based on the evidence, rosemary extract compounds can affect wound healing. The aim of this study was to determine the effect of rosemary ointment on pressure ulcer healing in patients admitted to the intensive care unit. Methods & Materials: In this single-blind randomized parallel clinical trial, 70 patients who met the inclusion criteria were selected purposefully and assigned to the groups by stratified randomization method. In the intervention group, rosemary ointment was applied once a day for seven days. The control group received routine care. Data were collected using the Pressure Ulcer Scale for Healing before the intervention and on the third and seventh days after the intervention. Data were analyzed using independent t-test, chi-square test, and two-way repeated measurements ANOVA with SPSS 18 software. Results: The mean scores of Pressure Ulcer Scale for Healing decreased significantly in the intervention group while remained unchanged in the control group (P=0.001) one week after the intervention. The effect of time and interaction effect was also significant (P=0.001). Comparison of the ratio of complete ulcer healing in the two groups showed a significant difference between the two groups (p=0.004). Conclusion: Rosemary ointment facilitated healing and prevented the progression of grade І pressure ulcers in the Intensive Care Unit. Therefore, the use of this ointment as a low-risk, uncomplicated, available, and inexpensive intervention, is recommended in such patients.

scholarly journals INVESTIGATING EFFECT OF NURSING INTERVENTIONS, BASED ON WELLS SCORE RESULTS, ON THE INCIDENCE OF DEEP VEIN THROMBOSIS IN PATIENTS ADMITTED TO THE INTENSIVE CARE UNIT

2018 ◽  
Vol 11 (5) ◽  
pp. 377
Author(s):  
Morteza Habibi Moghadam ◽  
Marzieh Asadizaker ◽  
Simin Jahani ◽  
Elham Maraghi ◽  
Hakimeh Saadatifar ◽  
...  
Keyword(s):  
Intensive Care Unit ◽  
Intensive Care ◽  
Deep Vein Thrombosis ◽  
Intervention Group ◽  
Control Group ◽  
Nursing Interventions ◽  
Vein Thrombosis ◽  
Wells Score ◽  
Deep Vein ◽  
Pitting Edema

 Objective: Venous thromboembolism, including deep vein thrombosis (DVT) and pulmonary embolism (PE), is a common complaint in critically ill patients. Therefore, the present study was conducted to determine the effect of nursing interventions, based on the Wells results, on the incidence of DVT in intensive care unit (ICU) patients.Methods: The present clinical trial was conducted on 72 ICU patients without DVT and PE who met the inclusion criteria according to Wells score in Dr. Ganjavian Hospital, Dezful in 2012. The participants were investigated and randomly divided into intervention (n=36) and control groups (n=36). The intervention group received preventive nursing measures based on the risk level determined by the Wells score, and routine therapeutic interventions were performed for the control group. Then, patients were evaluated using Wells score, D-dimer testing, and Doppler sonography on the 1st, 5th, and 10th days. Data were finally coded and entered into SPSS version 23. Data analysis was performed using Chi-square, Fisher’s exact, and Mann–Whitney U tests.Results: The incidence of DVT in both groups showed that 2 patients of the control group who were identified to be at risk using the Wells score were diagnosed with DVT while none of the patients of the intervention group experienced DVT. The present study showed that 22.2% of the patients of the control group suffered from non-pitting edema, which was significantly different from the intervention group (p=0.005).Conclusion: The results of the present study showed that using the Wells score for early identification of the at-risk patients and nursing interventions based on this score’s results is helpful in the prevention of DVT. Appropriate nursing interventions were also effective in reducing the incidence of non-pitting edema in the lower extremities.

Improving Family Communications at the End of Life: Implications for Length of Stay in the Intensive Care Unit and Resource Use

2003 ◽  
Vol 12 (4) ◽  
pp. 317-324 ◽  
Author(s):  
Tom Ahrens ◽  
Valerie Yancey ◽  
Marin Kollef
Keyword(s):  
Intensive Care Unit ◽  
Intensive Care ◽  
Length Of Stay ◽  
End Of Life ◽  
Resource Utilization ◽  
Intervention Group ◽  
Clinical Nurse Specialist ◽  
Control Group ◽  
Nurse Specialist ◽  
Clinical Nurse

• Background Inadequate communication persists between healthcare professionals and patients and patients’ families in intensive care units. Unwanted or ineffective treatments can occur when patients’ goals of care are unknown or not honored, increasing costs and care. Having the primary physician provide medical information and then having a physician and clinical nurse specialist team improve opportunities for patients and their families to process that information could improve the situation. This model has not been tested for its effect on patients’ outcomes and resource utilization.• Objectives To evaluate the effect of a communication team that included a physician and a clinical nurse specialist on length of stay and costs for patients near the end of life in the intensive care unit.• Methods During a 1-year period, patients judged to be at high risk for death (N = 151) were divided into 2 groups: 43 patients who were cared for by the medical director teamed with a clinical nurse specialist and 108 patients who received standard care, provided by an attending physician.• Results Compared with the control group, patients in the intervention group had significantly shorter stays in both the intensive care unit (6.1 vs 9.5 days) and the hospital (11.3 vs 16.4 days) and had lower fixed ($15 559 vs $24 080) and variable ($5087 vs $8035) costs.• Conclusions Use of a physician and a clinical nurse specialist focused on improving communication with patients and patients’ families reduced lengths of stay and resource utilization.

scholarly journals Effects of Ginger on clinical manifestations and paraclinical features of patients with Severe Acute Respiratory Syndrome due to COVID-19: A structured summary of a study protocol for a randomized controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Omid Safa ◽  
Mehdi Hassaniazad ◽  
Mehdi Farashahinejad ◽  
Parivash Davoodian ◽  
Habib Dadvand ◽  
...  
Keyword(s):  
Clinical Trial ◽  
Severe Acute Respiratory Syndrome ◽  
Pharmaceutical Company ◽  
Standard Treatment ◽  
Clinical Manifestations ◽  
Control Group ◽  
Exclusion Criteria ◽  
Positive Polymerase Chain Reaction ◽  
Gi Symptoms ◽  
Full Protocol

Abstract Objectives We investigate the effects of Ginger, compared to the usual therapeutic regimen on clinical manifestations and paraclinical features in patients with confirmed COVID-19 that are moderately ill. Trial design This is a single center, randomized, double-blind, placebo-controlled clinical trial with parallel group design. Participants Inclusion criteria: 1. Patients admitted to Severe Acute Respiratory Syndrome (SARS) Departments at Shahid Mohammadi Hospital, Bandar Abbas, Iran 2. Age ≥18 years (weight ≥35 kg) 3. Hospitalized ≤48 hours 4. Confirmed SARS-CoV-2 diagnosis (Positive polymerase chain reaction (PCR)) 5. Moderate pneumonia and lung involvement in imaging 6. Signing informed consent and willingness of study participant to accept randomization to any assigned treatment arm Exclusion criteria: 1. Underlying diseases, including heart disease, chronic hypertension, severe renal failure, severe liver failure, and thyroid disorders 2. Use of warfarin, selective serotonin reuptake inhibitors (SSRIs), monoamine oxidase inhibitors (MAOIs), diuretics, corticosteroids, and antiarrhythmic drugs 3. Severe and critical pneumonia 4. History of known allergy to Ginger 5. Pregnancy and breastfeeding Intervention and comparator Intervention group: The standard treatment regimen for COVID-19 along with Ginger-based herbal tablets (Vomigone ®, Dineh Pharmaceutical Company, Iran) at a dose of 1000 mg three times a day for a period of seven days. Control group: The standard treatment for COVID-19 based on the Iranian Ministry of Health and Medical Education's protocol, along with Vomigone-like placebo tablets (Dineh Pharmaceutical Company, Iran) at a dose of two tablets three times a day for a period of seven days. Main outcomes The primary outcome is recovery rate of clinical symptoms, including fever, dry cough, tiredness, and GI symptoms as well as paraclinical features, including thrombocytopenia, lymphocytopenia, and C-reactive protein within seven days of randomization. Time to improvement of clinical and paraclinical features along with the incidence of serious adverse events are the secondary outcomes within seven days of randomization. Randomization An interactive web-based system will be used to allocate eligible participants, based on the inclusion and exclusion criteria, to one of the two study arms (in a 1:1 ratio) using block randomization. Blinding (masking) All study participants, research coordinators, clinicians, nurses, and investigators will be blinded to the group assignment. Numbers to be randomized (sample size) A total of 84 participants will be randomized into two groups of 42 patients. Trial Status The protocol is Version 1.0, May 23, 2020. Recruitment began July 21, 2020, and is anticipated to be completed by October 30, 2020. Trial registration This clinical trial has been registered in the Iranian Registry of Clinical Trials (IRCT). The registration number is “IRCT20200506047323N1”. Registration date is 23 May 2020. Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol.

Cerebral Oximetry Monitoring to Maintain Normal Cerebral Oxygen Saturation during High-risk Cardiac Surgery

2016 ◽  
Vol 124 (4) ◽  
pp. 826-836 ◽  
Author(s):  
Alain Deschamps ◽  
Richard Hall ◽  
Hilary Grocott ◽  
C. David Mazer ◽  
Peter T. Choi ◽  
...  
Keyword(s):  
Intensive Care Unit ◽  
Cardiac Surgery ◽  
Intensive Care ◽  
Intervention Group ◽  
Perioperative Outcomes ◽  
Control Group ◽  
Cerebral Oxygen ◽  
Cerebral Desaturation ◽  
Cerebral Saturation

Abstract Background Cerebral oxygen desaturation during cardiac surgery has been associated with adverse perioperative outcomes. Before a large multicenter randomized controlled trial (RCT) on the impact of preventing desaturations on perioperative outcomes, the authors undertook a randomized prospective, parallel-arm, multicenter feasibility RCT to determine whether an intervention algorithm could prevent desaturations. Methods Eight Canadian sites randomized 201 patients between April 2012 and October 2013. The primary outcome was the success rate of reversing cerebral desaturations below 10% relative to baseline in the intervention group. Anesthesiologists were blinded to the cerebral saturation values in the control group. Intensive care unit personnel were blinded to cerebral saturation values for both groups. Secondary outcomes included the area under the curve of cerebral desaturation load, enrolment rates, and a 30-day follow-up for adverse events. Results Cerebral desaturations occurred in 71 (70%) of the 102 intervention group patients and 56 (57%) of the 99 control group patients (P = 0.04). Reversal was successful in 69 (97%) of the intervention group patients. The mean cerebral desaturation load (SD) in the operating room was smaller for intervention group patients compared with control group patients (104 [217] %.min vs. 398 [869] %.min, mean difference, −294; 95% CI, −562 to −26; P = 0.03). This was also true in the intensive care unit (P = 0.02). There were no differences in adverse events between the groups. Conclusions Study sites were successful in reversal of desaturation, patient recruitment, randomization, and follow-up in cardiac surgery, supporting the feasibility of conducting a large multicenter RCT.

scholarly journals EFFECTIVENESS OF SUCTION ABOVE CUFF ENDOTRACHEAL TUBE (SACETT) IN PREVENTING VENTILATOR ASSOCIATED PNEUMONIA IN CRITICAL PATIENTS IN INTENSIVE CARE UNIT

2018 ◽  
Vol 4 (4) ◽  
pp. 380-389
Author(s):  
Arfiyan Sukmadi ◽  
Rr Sri Endang Pujiastuti ◽  
Aris Santjaka ◽  
Supriyadi Supriyadi
Keyword(s):  
Intensive Care Unit ◽  
Intensive Care ◽  
Endotracheal Tube ◽  
Intervention Group ◽  
Control Group ◽  
Ventilator Associated Pneumonia ◽  
Mechanical Ventilator ◽  
Control Group Design ◽  
Bacterial Development ◽  
Critical Patients

Background: The mechanical ventilator is an indispensable breathing tool in the Intensive Care Unit (ICU). But the mechanical ventilator is associated with the risk of Ventilator Associated Penumonia (VAP). VAP occurs due to poor hygiene of the endotracheal tube (ETT). ETT hygiene should be maintained to inhibit bacterial development in the lungs using suction above cuff endotracheal tube (SACETT) to prevent VAP.Objective: To analyze the effectiveness of SACETT in preventing Ventilator Associated Pneumonia (VAP) in critical patients in the ICU.Methods: This was a quasy experimental study with posttest only with control group design with 15 samples in intervention group (SACETT and Chlorhexidine 0.2%) and 15 in control group (ETT, Open Suction, and Chlorhexidine 0.2%) with purposive technique sampling. The Simplified Clnical Pulmonary Infection Score (CPIS) was used to measure VAP.Results: This study illustrates that there was no VAP incidence in the intervention group, and as much as 13.3% VAP in the control group. SACETT was more effective in preventing VAP than in standard ETT on day 4 (p = 0.001).Conclusion: SACETT is more effective in preventing VAP than standard ETT in the fourth day in patients with neurological, cardiovascular, urinary, digestive, and immune system disorders.

scholarly journals Proactive Prophylaxis With Azithromycin and HydroxyChloroquine in Hospitalised Patients With COVID-19 (ProPAC-COVID): A structured summary of a study protocol for a randomised controlled trial

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Pradeesh Sivapalan ◽  
Charlotte Suppli Ulrik ◽  
Rasmus Dahlin Bojesen ◽  
Therese Sophie Lapperre ◽  
Josefin Viktoria Eklöf ◽  
...  
Keyword(s):  
Study Protocol ◽  
Standard Treatment ◽  
Controlled Trial ◽  
Intervention Group ◽  
Cardiac Conduction ◽  
Control Group ◽  
Qtc Interval ◽  
Patient Will ◽  
Full Protocol ◽  
Fertile Women

Abstract Objectives The aim of this randomised GCP-controlled trial is to clarify whether combination therapy with the antibiotic azithromycin and hydroxychloroquine via anti-inflammation/immune modulation, antiviral efficacy and pre-emptive treatment of supra-infections can shorten hospitalisation duration for patients with COVID-19 (measured as "days alive and out of hospital" as the primary outcome), reduce the risk of non- invasive ventilation, treatment in the intensive care unit and death. Trial design This is a multi-centre, randomised, Placebo-controlled, 2-arm ratio 1:1, parallel group double-blind study. Participants 226 participants are recruited at the trial sites/hospitals, where the study will take place in Denmark: Aalborg, Bispebjerg, Gentofte, Herlev, Hillerød, Hvidovre, Odense and Slagelse hospitals. Inclusion criteria: • Patient admitted to Danish emergency departments, respiratory medicine departments or internal medicine departments • Age≥ 18 years • Hospitalized ≤48 hours • Positive COVID-19 test / diagnosis during the hospitalization (confirmed). • Men or non-fertile women. Fertile women* must not be pregnant, i.e. negative pregnancy test must be available at inclusion • Informed consent signed by the patient *Defined as after menarche and until postmenopausal (no menstruation for 12 months) Exclusion criteria: • At the time of recruitment, the patient uses >5 LO2/min (equivalent to 40% FiO2 if measured) • Known intolerance/allergy to azithromycin or hydroxychloroquine or hypersensitivity to quinine or 4-aminoquinoline derivatives • Neurogenic hearing loss • Psoriasis • Retinopathy • Maculopathy • Visual field changes • Breastfeeding • Severe liver diseases other than amoebiasis (INR> 1.5 spontaneously) • Severe gastrointestinal, neurological and hematological disorders (investigator-assessed) • eGFR <45 ml/min/1.73 m2 • Clinically significant cardiac conduction disorders/arrhythmias or prolonged QTc interval (QTc (f) of> 480/470 ms). • Myasthenia gravis • Treatment with digoxin* • Glucose-6-phosphate dehydrogenase deficiency • Porphyria • Hypoglycaemia (Blood glucose at any time since hospitalization of <3.0 mmol/L) • Severe mental illness which significantly impedes cooperation • Severe linguistic problems that significantly hinder cooperation • Treatment with ergot alkaloids *The patient must not be treated with digoxin for the duration of the intervention. For atrial fibrillation/flutter, select according to the Cardiovascular National Treatment Guide (NBV): Calcium antagonist, Beta blocker, direct current (DC) conversion or amiodarone. In case of urgent need for digoxin treatment (contraindication for the aforementioned equal alternatives), the test drug should be paused, and ECG should be taken daily. Intervention and comparator Control group: The control group will receive the standard treatment + placebo for both types of intervention medication at all times. If part or all the intervention therapy being investigated becomes standard treatment during the study, this may also be offered to the control group. Intervention group: The patients in the intervention group will also receive standard care. Immediately after randomisation to the intervention group, the patient will begin treatment with: Azithromycin: Day 1-3: 500 mg x 1 Day 4-15: 250 mg x 1 If the patient is unable to take the medication orally by themselves, the medication will, if possible, be administered by either stomach-feeding tube, or alternatively, temporary be changed to clarithromycin 500 mg x 2 (this only in agreement with either study coordinator Pradeesh Sivapalan or principal investigator Jens-Ulrik Stæhr Jensen). This will also be done in the control group if necessary. The patient will switch back to azithromycin when possible. Hydroxychloroquine: Furthermore, the patient will be treated with hydroxychloroquine as follows: Day 1-15: 200 mg x 2 Main outcomes • Number of days alive and discharged from hospital within 14 days (summarises both whether the patient is alive and discharged from hospital) ("Days alive and out of hospital") Randomisation The sponsor (Chronic Obstructive Pulmonary Disease Trial Network, COP:TRIN) generates a randomisation sequence. Randomisation will be in blocks of unknown size and the final allocation will be via an encrypted website (REDCap). There will be stratification for age (>70 years vs. <=70 years), site of recruitment and whether the patient has any of the following chronic lung diseases: COPD, asthma, bronchiectasis, interstitial lung disease (Yes vs. No). Blinding (masking) Participants and study personnel will both be blinded, i.e. neither will know which group the participant is allocated to. Numbers to be randomised (sample size) This study requires 226 patients randomised 1:1 with 113 in each group. Trial Status Protocol version 1.8, from April 16, 2020. Recruitment is ongoing (first patient recruited April 6, 2020; final patient expected to be recruited October 31, 2020). Trial registration ClinicalTrials.gov Identifier: NCT04322396 (registered March 26, 2020) Full protocol The full protocol is attached as an additional file, accessible from the Trials website (Additional file 1). In the interest in expediting dissemination of this material, the familiar formatting has been eliminated; this Letter serves as a summary of the key elements of the full protocol. The study protocol has been reported in accordance with the Standard Protocol Items: Recommendations for Clinical Interventional Trials (SPIRIT) guidelines (Additional file 2).

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