scholarly journals Effects of Donepezil and Medroxyprogesterone Versus Placebo on Weaning in Adult Patients With Non-Pulmonary Etiologies Receiving Invasive Mechanical Ventilation: A triple‐blind Randomized Clinical Trial

2021 ◽  
Vol 12 ◽  
Author(s):  
Zahra Alizadeh ◽  
Adeleh Sahebnasagh ◽  
Navid Hadadzadegan ◽  
Farhad Mohammadi ◽  
Fatemeh Saghafi

Background: Medroxyprogesterone and donepezil could be used as respiratory stimulants in ventilated patients. However, no randomized placebo-controlled trial is available to confirm this approach and compare these drugs. The aim of the current study was to evaluate the effects of donepezil or medroxyprogesterone compared to the placebo in improvement in respiratory status and weaning facilitation in critically ill adult patients receiving mechanical ventilation.Material and Methods: This randomized, triple-blind trial was conducted on 78 ventilated patients in intensive care units (ICU). Patients who were intubated due to pulmonary disorders were ruled out. Patients were randomized in a 1:1:1 ratio to receive 5 mg donepezil (n = 23) or 5 mg medroxyprogesterone (n = 26), or placebo (n = 24) twice a day until weaning (maximum 10 days). The primary endpoints were weaning duration, and duration of invasive mechanical ventilation. Secondary endpoints included rate of successful weaning, changes in arterial blood gas (ABG) parameters, GCS and sequential organ failure assessment (SOFA) score, hemoglobin (Hgb), ICU-mortality, and duration of ICU stay, were measured before and after the intervention and if successful weaning was recorded.Results: Of 78 studied patients who were randomized, 59 weaned successfully. 87% patients in donepezil and 88.5% patients in medroxyprogesterone groups were successfully weaned compared to 66.7% patients in the placebo group. However, this difference was not statistically significant (p-Value = 0.111). Changes in pH, mean duration of intubation, and weaning duration were statistically different in donepezil compared with the control group (p-Value < 0.05). No significant difference in ABG, Hgb, GCS and SOFA score, and duration of intubation were seen in the medroxyprogesterone group, but weaning duration was significantly reduced to 1.429 days compared with the control group (p-Value = 0.038).Conclusion: The results of this clinical trial have demonstrated that the administered dose of medroxyprogesterone and donepezil can expedite the weaning process by reducing the weaning duration compared to placebo. Furthermore, the total duration of invasive ventilation was significantly lower in the donepezil group compared to the control group. Future clinical trials with a larger sample size will determine the exact role of medroxyprogesterone and donepezil in mechanically ventilated patients.Clinical Trial Registration:https://irct.ir/IRCT20190810044500N2 (April 1, 2020).

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Federico Longhini ◽  
Laura Pasin ◽  
Claudia Montagnini ◽  
Petra Konrad ◽  
Andrea Bruni ◽  
...  

Abstract Background Post-operative pulmonary complications (PPC) can develop in up to 13% of patients undergoing neurosurgical procedures and may adversely affect clinical outcome. The use of intraoperative lung protective ventilation (LPV) strategies, usually including the use of a low Vt, low PEEP and low plateau pressure, seem to reduce the risk of PPC and are strongly recommended in almost all surgical procedures. Nonetheless, feasibility of LPV strategies in neurosurgical patients are still debated because the use of low Vt during LPV might result in hypercapnia with detrimental effects on cerebrovascular physiology. Aim of our study was to determine whether LPV strategies would be feasible compared with a control group in adult patients undergoing cranial or spinal surgery. Methods This single-centre, pilot randomized clinical trial was conducted at the University Hospital “Maggiore della Carità” (Novara, Italy). Adult patients undergoing major cerebral or spinal neurosurgical interventions with risk index for pulmonary post-operative complications > 2 and not expected to need post-operative intensive care unit (ICU) admission were considered eligible. Patients were randomly assigned to either LPV (Vt = 6 ml/kg of ideal body weight (IBW), respiratory rate initially set at 16 breaths/min, PEEP at 5 cmH2O and application of a recruitment manoeuvre (RM) immediately after intubation and at every disconnection from the ventilator) or control treatment (Vt = 10 ml/kg of IBW, respiratory rate initially set at 6–8 breaths/min, no PEEP and no RM). Primary outcomes of the study were intraoperative adverse events, the level of cerebral tension at dura opening and the intraoperative control of PaCO2. Secondary outcomes were the rate of pulmonary and extrapulmonary complications, the number of unplanned ICU admissions, ICU and hospital lengths of stay and mortality. Results A total of 60 patients, 30 for each group, were randomized. During brain surgery, the number of episodes of intraoperative hypercapnia and grade of cerebral tension were similar between patients randomized to receive control or LPV strategies. No difference in the rate of intraoperative adverse events was found between groups. The rate of postoperative pulmonary and extrapulmonary complications and major clinical outcomes were similar between groups. Conclusions LPV strategies in patients undergoing major neurosurgical intervention are feasible. Larger clinical trials are needed to assess their role in postoperative clinical outcome improvements. Trial registration registered on the Australian New Zealand Clinical Trial Registry (www.anzctr.org.au), registration number ACTRN12615000707561.


Author(s):  
Ali Mohammadpour ◽  
Mousa Sajadi ◽  
Somayyeh Maghami ◽  
Hossein Soltani

Objective: Increased gastric residual volume is a complication of enteral nutrition intolerance that leads to gastrointestinal complications such as nausea, vomiting, and aspiration pneumonia. The present study was conducted to determine the effect of gastric gas emptying on the residual gastric volume in mechanically-ventilated patients fed through nasogastric tubes.Methods: This randomized, single-blind, clinical trial was conducted on two groups of patients in the intensive care unit (ICU) of Kamyab Hospital of Mashhad. A total of 64 patients were randomly divided into a case and a control group. In the case group, the gastric gases accumulated through the nasogastric tube were emptied by applying palm pressure on the epigastric region. The control group did not undergo this intervention but received the routine care provided in the ward. Data were collected using a demographic questionnaire and a form containing records of the patients’ residual gastric volume and disease-related information. The residual gastric volume was measured and compared in the two groups before and after the intervention. Data were analyzed in SPSS-19 using the Chi-square test, the independent t-test, and the repeated measures ANOVA at the significance level of 5%.Results: The residual gastric volume did not differ significantly between the two groups before the intervention (p=0.14); after the intervention; however, a significant reduction was observed in the case group compared to the controls (p=0.007).Conclusion: Gastric gas emptying helps reduce the residual gastric volume in mechanically-ventilated patients fed through nasogastric tubes. Further studies are recommended to further ensure the benefits of this method.


Author(s):  
Cristina Avendano-Sola ◽  
Antonio Ramos-Martinez ◽  
Elena Munez-Rubio ◽  
Belen Ruiz-Antoran ◽  
Rosa Malo de Molina ◽  
...  

Background: Passive immunotherapy with convalescent plasma (CP) is a potential treatment for COVID-19 for which evidence from controlled clinical trials is lacking. Methods: We conducted a multi-center, randomized clinical trial in patients hospitalized for COVID-19. All patients received standard of care treatment, including off-label use of marketed medicines, and were randomized 1:1 to receive one dose (250-300 mL) of CP from donors with IgG anti-SARS-CoV-2. The primary endpoint was the proportion of patients in categories 5, 6 or 7 of the COVID-19 ordinal scale at day 15. Results: The trial was stopped after first interim analysis due to the fall in recruitment related to pandemic control. With 81 patients randomized, there were no patients progressing to mechanical ventilation or death among the 38 patients assigned to receive plasma (0%) versus 6 out of 43 patients (14%) progressing in control arm. Mortality rates were 0% vs 9.3% at days 15 and 29 for the active and control groups, respectively. No significant differences were found in secondary endpoints. At inclusion, patients had a median time of 8 days (IQR, 6-9) of symptoms and 49,4% of them were positive for anti-SARS-CoV-2 IgG antibodies. Conclusions: Convalescent plasma could be superior to standard of care in avoiding progression to mechanical ventilation or death in hospitalized patients with COVID-19. The strong dependence of results on a limited number of events in the control group prevents drawing firm conclusions about CP efficacy from this trial. (Funded by Instituto de Salud Carlos III; NCT04345523).


2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Mahla Daliri B.O. ◽  
Hassan M. Majd ◽  
Ali Moradi

Abstract Background In COVID 19 era, the literature on e-learning, or particularly m-learning, has considerably increased focusing on the subject of medical knowledge transfer. Considering the importance of orthopedic knowledge for general practitioners and the inadequacy of the orthopedics internship duration in Mashhad University of Medical Sciences (MUMS), we have developed and investigated a smartphone orthopedic educational application named “Orthobox”. Methods In a quasi-clinical before-after trial study, we investigated the benefits of Orthobox application for medical interns attending MUMS orthopedic departments. A total of 120 students (64 and 56 students in control and case groups respectively) were recruited. The application consists of five main parts of medication, common order samples, common prescriptions, cast and splint types, and educational movies. Students who passed the course without getting access to the application (control group) and students who were also using application during the course (case group) were defined, and comparison was done between them objectively through final exam score comparison and subjectively through Visual Analogue Scale (VAS) questionnaire score comparison. Besides, using case group students’ activity report provided by the application panel, correlational analysis was done on their amount of activity on each of the main parts of the application and the corresponding question exam and VAS score separately. Results The case group of the study generally achieved higher final exam scores, mainly on Order question score (P value<0.001). Total VAS scores were also greater in case group (P value =0.001). It has also been identified that there is a notable positive trend between student’s amount of usage of the application and their final exam scores through correlational analysis. This correlation was not significant about students’ application visit numbers and VAS scores. Conclusion These results suggest that m-learning has got the potential to improve students’ medical knowledge and skills by organizing must-to-learn content specified for intern students of orthopedics on one hand, and cause more satisfaction in students about their education on the other hand. Trial registration This study was not registered because it is a quasi-clinical trial study. Level of evidence Level III (Evidence obtained from well-designed controlled trials without randomization (i.e. quasi-experimental).


2020 ◽  
Vol 9 ◽  
pp. 1918 ◽  
Author(s):  
Mahnaz Sadeghi-Shabestari ◽  
Yalda Jabbari Moghaddam ◽  
Hasan Rezapoor ◽  
Mojataba Sohrabpour

Background: Allergic rhinitis (AR) is one of the most common diseases in the world and affects about 10-50% of the general population. Probiotics are live microorganisms that help the normal state of the intestine, and if prescribed correctly, they can stimulate the mucosal immune system to prevent inflammatory symptoms of allergy and atopy. The present study aims to investigate the role of probiotics in the treatment of AR when added to standard therapy as adjuvant agents. Materials and Methods: In this clinical trial study, 28 patients older than 15 years with AR randomly divided into probiotics and control groups. The probiotics group received standard therapy for AR accompanied by probiotic capsules every 12 hours for eight weeks, whereas the control group received standard therapy for AR with placebo capsules as the same protocol. Data were analyzed using SPSS Version 23 (IBM Corporation, Armonk, NY, USA) and, the P-value less than 0.05 was considered statistically significant. Results: In the probiotics group, 14.3% of patients had sneezing at the baseline, which significantly decreased to 4.6% (P<0.01). Also, the necessity for nasal and oral corticosteroids after treatment with probiotics in the probiotics group was less than the control group (P<0.01). Although cough, nasal discharge, conchae hypertrophy, and night sleep disorders reduced after treatment with probiotics, this reduction was not statistically significant between the two groups. Conclusion: Based on the results of this clinical trial, the use of probiotics had no significant effect on the outcome of patients with AR. [GMJ.2020;9:e1918] 


Author(s):  
Dr. Metilda ◽  
Dr. A. Jaganath

Mechanical ventilation is widely used to treat patients with critical conditions. This treatment is usually applied for difficulty in breathing. The use of mechanical ventilation devices has unique benefits to the patient. However, it can also cause various problems. Reduction in communication rank as one of the most negative experiences in mechanically ventilated patients. Effective communication with ventilator-based patients is essential. Nursing management of a mechanically ventilated patient is challenging on many levels, requiring a wealth of high technical skills. The Patient Communications Board improves communication, maintains information and creates a comfortable, attractive setting for patient, family and health care workers. The research methodology used for the study is a Quasi experimental approach, post-test only design with a comparison group to assess the effect of the communication board on the level of satisfaction over communication among clients on mechanical ventilator. The sample was selected by purposive sampling technique and included 30 (experimental group-15, control group-15), mechanically ventilated patients in PESIMR hospital, Kuppam. The control group patients were provided with routine communication methods, while the experimental group were communicated with communication board. The level of satisfaction on communication was assessed by a 15items rating scale. Data was analysed using both the descriptive and inferential statistics. There was a significant difference in the level of satisfaction on communication among the patients who were communicated using communication board compared to the routine method of communication. The communication board had significantly improved the communication pattern and increased the satisfaction among the patients who are mechanically ventilated.


2013 ◽  
pp. 184-188 ◽  
Author(s):  
Alvaro Sanabria ◽  
Ximena Gomez ◽  
Valentin Vega ◽  
Luis Carlos Dominguez ◽  
Camilo Osorio

Introduction: There are no established guidelines for selecting patients for early tracheostomy. The aim was to determine the factors that could predict the possibility of intubation longer than 7 days in critically ill adult patients. Methods: This is cohort study made at a general intensive care unit. Patients who required at least 48 hours of mechanical ventilation were included. Data on the clinical and physiologic features were collected for every intubated patient on the third day. Uni- and multivariate statistical analyses were conducted to determine the variables associated with extubation. Results: 163 (62%) were male, and the median age was 59±17 years. Almost one-third (36%) of patients required mechanical ventilation longer than 7 days. The variables strongly associated with prolonged mechanical ventilation were: age (HR 0.97 (95% CI 0.96-0.99); diagnosis of surgical emergency in a patient with a medical condition (HR 3.68 (95% CI 1.62-8.35), diagnosis of surgical condition-non emergency (HR 8.17 (95% CI 2.12-31.3); diagnosis of non-surgical-medical condition (HR 5.26 (95% CI 1.85-14.9); APACHE II (HR 0.91 (95% CI 0.85-0.97) and SAPS II score (HR 1.04 (95% CI 1.00-1.09) The area under ROC curve used for prediction was 0.52. 16% of patients were extubated after day 8 of intubation. Conclusions: It was not possible to predict early extubation in critically ill adult patients with invasive mechanical ventilation with common clinical scales used at the ICU. However, the probability of successfully weaning patients from mechanical ventilation without a tracheostomy is low after the eighth day of intubation.


Stroke ◽  
2021 ◽  
Vol 52 (Suppl_1) ◽  
Author(s):  
Tomoyuki Iwai ◽  
Shin Nakayama

Introduction: Cerebral edema following cardiac arrest and cardiopulmonary resuscitation (CA/CPR) is associated with unfavorable neurologic outcome. The Na + -K + -2Cl - water cotransporter NKCC1 is suspected to be a critical mediator of edema formation after ischemia. It is reported that β1 adrenoreceptor antagonists protect neurons following brain ischemia in rodents. β1 adrenoreceptor antagonists inhibit the Na + -K + -ATPase, which can inhibit driving force of NKCC1 that theoretically reduces cerebral edema following ischemia-reperfusion injury. In this study, we examined whether landiolol, a selective β1 adrenoreceptor antagonist, attenuates cerebral edema following CA/CPR. Methods: Isoflurane-anesthetized adult male mice (C57BL/6J, 25-30g) were randomized into landiolol group or control group. After 7-min CA followed by CPR, landiolol (0.5ml, 830μg/ml) was administered by continuous infusion intravenously for 4 hours. Animals in control group were given normal saline (0.5ml) in the same manner. Twenty-four hours after CA/CPR, the brain was removed to assess brain water content using wet-to-dry method. The primary outcome was measurement of the brain water content. Heart rate and arterial blood pressure were recorded. Measured parameters were analyzed by one-way ANOVA with post hoc Tukey-Kramer test using SPSS® statistics 25. Differences were considered statistically significant at a P value < 0.05. Results: Brain water contents was increased in control group mice after CA/CPR (n=10) compared with those in sham operated mice (n=5) (79.5±0.85% vs 78.3±0.14%, P=0.003). Compared with control group, landiolol treatment significantly reduced brain water content in mice subjected to CA/CPR (n=12) (78.9±0.51% vs 79.5±0.85%, P=0.04). Conclusion: Landiolol attenuated brain edema following CA/CPR. These results may suggest selective β1-blocker could be alternative treatment for neuroprotection in patients who suffered CA/CPR.


Author(s):  
Nicolás Merchante ◽  
Sheila Cárcel ◽  
José Carlos Garrido-Gracia ◽  
Marta Trigo-Rodríguez ◽  
María Ángeles Esteban Moreno ◽  
...  

In this phase II, open-label, randomized, controlled clinical trial of 115 patients hospitalized with COVID-19 and systemic inflammation, early use of sarilumab was associated with a low risk of acute respiratory distress syndrome requiring high-flow devices or mechanical ventilation. Objective: To investigate the efficacy and safety of early treatment with sarilumab, added to standard of care (SOC), in hospitalised adults with COVID-19. Methods: Phase II, open-label, randomized, controlled clinical trial of hospitalised patients with COVID-19 pneumonia and interleukin (IL)-6 levels ≥ 40 pg/mL and/or D-dimer > 1500 ng/mL. Participants were randomized (1:1:1) to receive SOC (control group), SOC plus a single subcutaneous dose of sarilumab 200 mg (Sarilumab-200) or SOC plus a single subcutaneous dose of sarilumab 400 mg (Sarilumab-400). The primary outcome variable was the development of acute respiratory distress syndrome (ARDS) requiring high-flow nasal oxygenation (HFNO), non-invasive mechanical ventilation (NIMV) or invasive mechanical ventilation (IMV) at day 28. Results: One-hundred and fifteen participants (control group, n = 39; Sarilumab-200, n = 37; Sarilumab-400, n = 39) were included. At randomization, 104 (90%) patients had supplemental oxygen and 103 (90%) received corticosteroids. Eleven (28%) patients in the control group, ten (27%) in Sarilumab-200 and five (13%) in Sarilumab-400 developed the primary outcome (hazard ratio [95% CI] of Sarilumab-400 vs control group: 0.41 [0.14-1.18]; p=0.09). Seven (6%) patients died: three in the control group and four in Sarilumab-200. There were no deaths in Sarilumab-400 (p = 0.079, log-rank test for comparisons with the control group). Conclusion: In patients recently hospitalised with COVID-19 pneumonia and features of systemic inflammation, early IL-6 blockade with a single dose of sarilumab 400 mg was safe and associated with a trend for better outcomes.


2019 ◽  
Vol 9 (1) ◽  
Author(s):  
Roland Smonig ◽  
Eric Magalhaes ◽  
Lila Bouadma ◽  
Olivier Andremont ◽  
Etienne de Montmollin ◽  
...  

Abstract Objective To determine whether potential exposure to natural light via windows is associated with reduced delirium burden in critically ill patients admitted to the ICU in a single room. Design Prospective single-center study. Setting Medical ICU of a university hospital, Paris, France. Patients Adult patients receiving invasive mechanical ventilation. Methods Consecutive patients admitted to a single room with (LIGHT group) or without (DARK group) exposure to natural light via windows were evaluated for delirium. The primary endpoint was the incidence of delirium. Main secondary endpoints included incidence of severe agitation intervened with antipsychotics and incidence of hallucinations. Results A total of 195 patients were included (LIGHT group: n = 110; DARK group: n = 85). The incidence of delirium was similar in the LIGHT group and the DARK group (64% vs. 71%; relative risk (RR) 0.89, 95% CI 0.73–1.09). Compared with the DARK group, patients from the LIGHT group were less likely to be intervened with antipsychotics for agitation episodes (13% vs. 25%; RR 0.52, 95% CI 0.27–0.98) and had less frequent hallucinations (11% vs. 22%; RR 0.49, 95% CI 0.24–0.98). In multivariate logistic regression analysis, natural light exposure was independently associated with a reduced risk of agitation episodes intervened with antipsychotics (adjusted odds ratio = 0.39; 95% CI 0.17–0.88). Conclusion Admission to a single room with potential exposure to natural light via windows was not associated with reduced delirium burden, as compared to admission to a single room without windows. However, natural light exposure was associated with a reduced risk of agitation episodes and hallucinations.


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