scholarly journals Efficacy of Corticosteroids Treatment on Reducing the Risk of Post-Extubation Stridor: Study Protocol for a Randomized Controlled Trial

2020 ◽  
Author(s):  
Jingyi Wang ◽  
Joseph Walline ◽  
Yili Dai ◽  
Lu Yin ◽  
Jiayuan Dai ◽  
...  
Keyword(s):  
Mechanical Ventilation ◽  
Controlled Trial ◽  
Extubation Failure ◽  
Hospital Length ◽  
Adult Patients ◽  
Hospital Length Of Stay ◽  
Intravenous Methylprednisolone ◽  
Randomized Controlled ◽  
Secondary Endpoints ◽  
Laryngeal Stridor

Abstract Background: Laryngotracheal injury is one of common complications of airway intubation, with severe cases leading to stridor or even extubation failure (need for reintubation within 48 hours after extubation). As corticosteroids have anti-inflammatory effects, they may play an important role in reducing the risk of post-extubation stridor and extubation failure among adult patients.Aim: To investigate the efficacy of corticosteroids on reducing the risk of post-extubation stridor. Methods: A multicenter, randomized, placebo-controlled trial will be performed. The trial will enroll 232 patients undergoing extubation from mechanical ventilation. The patients will be randomly assigned to treatment four hours prior to extubation either with intravenous methylprednisolone 40mg or placebo. The primary endpoint is the occurrence of laryngeal stridor within 48 hours, and the secondary endpoints are the need for respiratory support or reintubation secondary to post-extubation stridor within 48 hours after extubation, side effects or corticosteroids, hospital length of stay, and 30-day mortality.Discussion: The trial will examine if corticosteroid therapy before extubation is effective at reducing the risk of post-extubation stridor-related complications among adult patients. Trial registration: Chictr.org.cn, ChiCTR2000030349. Registered on 29 Feb 2020.

scholarly journals Impact of point-of-care ultrasound on the hospital length of stay for internal medicine inpatients with cardiopulmonary diagnosis at admission: study protocol of a randomized controlled trial—the IMFCU-1 (Internal Medicine Focused Clinical Ultrasound) study

Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Ximena Cid ◽  
David Canty ◽  
Alistair Royse ◽  
Andrea B. Maier ◽  
Douglas Johnson ◽  
...  
Keyword(s):  
Internal Medicine ◽  
Randomized Controlled Trial ◽  
Length Of Stay ◽  
Patient Management ◽  
Point Of Care ◽  
Controlled Trial ◽  
Hospital Length ◽  
Hospital Length Of Stay ◽  
Point Of Care Ultrasound ◽  
Randomized Controlled

Abstract Background Point-of-care ultrasound (POCUS) is emerging as a reliable and valid clinical tool that impacts diagnosis and clinical decision-making as well as timely intervention for optimal patient management. This makes its utility in patients admitted to internal medicine wards attractive. However, there is still an evidence gap in all the medical setting of how its use affects clinical variables such as length of stay, morbidity, and mortality. Methods/design A prospective randomized controlled trial assessing the effect of a surface POCUS of the heart, lungs, and femoral and popliteal veins performed by an internal medicine physician during the first 24 h of patient admission to the unit with a presumptive cardiopulmonary diagnosis. The University of Melbourne iHeartScan, iLungScan, and two-point venous compression protocols are followed to identify left and right ventricular function, significant valvular heart disease, pericardial and pleural effusion, consolidation, pulmonary edema, pneumothorax, and proximal deep venous thrombosis. Patient management is not commanded by the protocol and is at the discretion of the treating team. A total of 250 patients will be recruited at one tertiary hospital. Participants are randomized to receive POCUS or no POCUS. The primary outcome measured will be hospital length of stay. Secondary outcomes include the change in diagnosis and management, 30-day hospital readmission, and healthcare costs. Discussion This study will evaluate the clinical impact of multi-organ POCUS in internal medicine patients admitted with cardiopulmonary diagnosis on the hospital length of stay. Recruitment of participants commenced in September 2018 and is estimated to be completed by March 2020. Trial registration Australian and New Zealand Clinical Trial Registry, ACTRN12618001442291. Registered on 28 August 2018.

scholarly journals Efficacy of prophylactic methylprednisolone on reducing the risk of post-extubation stridor in patients after an emergency intubation: study protocol for a randomized controlled trial

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Jingyi Wang ◽  
Joseph Harold Walline ◽  
Lu Yin ◽  
Yili Dai ◽  
Jiayuan Dai ◽  
...  
Keyword(s):  
Adverse Effects ◽  
Controlled Trial ◽  
Extubation Failure ◽  
Hospital Length ◽  
Hospital Length Of Stay ◽  
Respiratory Support ◽  
Corticosteroid Administration ◽  
Emergency Intubation ◽  
Treatment Regimens ◽  
Cuff Leak

Abstract Background Post-extubation stridor (PES) is one of the most common complications of invasive respiratory support, with severe cases leading to possible extubation failure (reintubation within 48 h) and increased mortality. Previous studies confirmed that prophylactic corticosteroids play an important role in reducing the risk of PES and extubation failure. However, few studies have looked at the efficacy of corticosteroids on preventing PES in patients after an emergency intubation. Aim To evaluate whether a single dose of methylprednisolone given over a set timeframe before extubation is effective in preventing PES in patients after an emergency intubation. Methods A multicenter, randomized, placebo-controlled trial will be performed in an emergency department (ED) setting. The trial will include 132 patients who fail a cuff-leak test (CLT) prior to the intervention. Patients will be randomly assigned to either intravenous methylprednisolone (40 mg) or placebo 4 h prior to extubation. Other eligible patients who pass the CLT will be included in a non-intervention (observation) group. The primary endpoint is the incidence of PES within 48 h after extubation. Secondary endpoints include oxygen therapy, respiratory support requirements, reintubation secondary to PES, adverse effects within 48 h after extubation, hospital length of stay, and hospital mortality. Discussion Patients who are intubated on an emergency basis have a higher risk of intubation-related complications. Previous studies have examined treatment regimens involving more than 10 different variations on corticosteroid treatments for PES prevention, while for ED therapy, only a simple and effective treatment would be appropriate. Corticosteroid administration is usually accompanied by adverse effects; thus, this study will be important for further risk stratification among intubated ED patients. Trial registration Chictr.org.cn ChiCTR2000030349. Registered on 29 February 2020.

scholarly journals Impact of point-of-care ultrasound on the hospital length of stay for internal medicine inpatients with cardiopulmonary diagnosis at admission. – Study protocol of a randomized controlled trial: the IMFCU-1 (Internal Medicine Focused Clinical Ultrasound) study

2019 ◽  
Author(s):  
Ximena Anaite Cid ◽  
David Canty ◽  
Alistair Royse ◽  
Andrea Maier ◽  
Douglas Johnson ◽  
...  
Keyword(s):  
Internal Medicine ◽  
Randomized Controlled Trial ◽  
Length Of Stay ◽  
Patient Management ◽  
Point Of Care ◽  
Controlled Trial ◽  
Hospital Length ◽  
Hospital Length Of Stay ◽  
Point Of Care Ultrasound ◽  
Randomized Controlled

Abstract Background Point-of-care ultrasound (POCUS) is emerging as a reliable and valid clinical tool that impacts diagnosis and clinical decision making, and timely intervention for optimal patient management. This makes its utility in patients admitted to internal medicine wards attractive. However, there is still an evidence gap in all the medical setting of how its use affects clinical variables such as length of stay, morbidity and mortality. Methods/design A prospective randomized controlled trial assessing the effect of a surface POCUS of the heart, lungs, and femoral and popliteal veins performed by an internal medicine physician during the first 24 hours of patient admission to the unit with a presumptive cardiopulmonary diagnosis. The University of Melbourne iHeartScan, iLungScan and 2-point venous compression protocols are followed to identify left and right ventricular function, significant valvular heart disease, pericardial and pleural effusion, consolidation, pulmonary edema, pneumothorax and proximal deep venous thrombosis. Patient management is not commanded by the protocol and is at the discretion of the treating team. A total of 250 patients will be recruited at one tertiary hospital. Participants are randomized to receive POCUS or no POCUS. The primary outcome measured will be hospital length of stay. Secondary outcomes include the change in diagnosis and management, 30-day hospital readmission and health care costs. Discussion This study will evaluate the clinical impact of multi-organ POCUS in internal medicine patients admitted with cardiopulmonary diagnosis on the hospital length of stay. Recruitment of participants has commenced in September of 2018 and is estimated to be completed by March 2020.

scholarly journals Effect of Vitamin D3 Supplementation vs Placebo on Hospital Length of Stay in Patients with Severe COVID-19: A Multicenter, Double-blind, Randomized Controlled Trial

2020 ◽  
Author(s):  
Igor H. Murai ◽  
Alan L. Fernandes ◽  
Lucas P. Sales ◽  
Ana J. Pinto ◽  
Karla F. Goessler ◽  
...  
Keyword(s):  
Vitamin D ◽  
Length Of Stay ◽  
Controlled Trial ◽  
Hospital Length ◽  
Hospitalized Patients ◽  
Hospital Length Of Stay ◽  
Double Blind ◽  
Hydroxyvitamin D ◽  
Randomized Controlled ◽  
25 Hydroxyvitamin D

ImportancePatients with COVID-19 may exhibit 25-hydroxyvitamin D deficiency, but the beneficial effects of vitamin D3 supplementation in this disease remain to be proven by randomized controlled trials.ObjectiveTo investigate the efficacy and safety of vitamin D3 supplementation in patients with severe COVID-19.Design, Setting, and ParticipantsThis is a multicenter, double-blind, randomized, placebo-controlled trial conducted in two centers (a quaternary hospital and a field hospital) in Sao Paulo, Brazil. The trial included 240 hospitalized patients with severe COVID-19. The study was conducted from June 2, 2020 to October 7, 2020.InterventionsPatients were randomly allocated (1:1 ratio) to receive either a single oral dose of 200,000 IU of vitamin D3 or placebo.Main Outcomes and MeasuresThe primary outcome was hospital length of stay, defined as hospital discharge from the date of randomization or death. Secondary outcomes were mortality, admission to ICU, mechanical ventilation requirement, and serum levels of 25-hydroxyvitamin D, creatinine, calcium, C-reactive protein, and D-dimer.ResultsOf 240 randomized patients (mean age, 56 years; 56% men), 232 (96.7%) were included in the primary analysis. Log-rank test showed that hospital length of stay was comparable between the vitamin D3 supplementation and placebo groups (7.0 days [95% CI, 6.1 to 7.9] and 7.0 days [95% CI, 6.2 to 7.8 days]; hazard ratio, 1.12 [95% CI, 0.9 to 1.5]; P = .379; respectively). The rate of mortality (7.0% vs 5.1%; P = .590), admission to ICU (15.8% vs 21.2%; P = .314), and mechanical ventilation requirement (7.0% vs 14.4%; P = .090) did not significantly differ between groups. Vitamin D3 supplementation significantly increased serum 25-hydroxyvitamin D levels compared to placebo (difference, 24.0 ng/mL [95% CI, 21.0% to 26.9%]; P = .001). No adverse events were observed.Conclusions and RelevanceAmong hospitalized patients with severe COVID-19, vitamin D3 supplementation was safe and increased 25-hydroxyvitamin D levels, but did not reduce hospital length of stay or any other relevant outcomes vs placebo. This trial does not support the use of vitamin D3 supplementation as an adjuvant treatment of patients with COVID-19.Key pointsQuestionCan vitamin D3 supplementation reduce hospital length of stay in hospitalized patients with severe COVID-19?FindingsIn this double-blind, randomized, placebo-controlled trial involving 240 hospitalized patients with severe COVID-19, a single dose of 200,000 IU of vitamin D3 supplementation was safe and effective in increasing 25-hydroxyvitamin D levels, but did not significantly reduce hospital length of stay (hazard ratio, 1.12) or any other clinically-relevant outcomes compared with placebo.MeaningVitamin D3 supplementation does not confer therapeutic benefits among hospitalized patients with severe COVID-19.

scholarly journals Efficacy of prophylactic methylprednisolone on reducing the risk of post-extubation stridor in patients after an emergency intubation: study protocol for a randomized controlled trial

2020 ◽  
Author(s):  
Jingyi Wang ◽  
Joseph Harold Walline ◽  
Lu Yin ◽  
Yili Dai ◽  
Jiayuan Dai ◽  
...  
Keyword(s):  
Adverse Effects ◽  
Controlled Trial ◽  
Extubation Failure ◽  
Hospital Length ◽  
Hospital Length Of Stay ◽  
Respiratory Support ◽  
Corticosteroid Administration ◽  
Emergency Intubation ◽  
Treatment Regimens ◽  
Cuff Leak

Abstract Background: Post-extubation stridor (PES) is one of the most common complications of invasive respiratory support, with severe cases leading to possible extubation failure (reintubation within 48 hours) and increased mortality. Previous studies confirmed that prophylactic corticosteroids play an important role in reducing the risk of PES and extubation failure. However, few studies have looked at the efficacy of corticosteroids on preventing PES in patients after an emergency intubation.Aim: To evaluate whether a single dose of methylprednisolone given over a set timeframe before extubation is effective in preventing PES in patients after an emergency intubation.Methods: A multicenter, randomized, placebo-controlled trial will be performed in an emergency department (ED) setting. The trial will include 132 patients who fail a cuff-leak test (CLT) prior to the intervention. Patients will be randomly assigned to either intravenous methylprednisolone (40mg) or placebo four hours prior to extubation. Other eligible patients who pass the CLT will be included in a non-intervention (observation) group. The primary endpoint is the incidence of PES within 48 hours after extubation. Secondary endpoints include oxygen therapy, respiratory support requirements, reintubation secondary to PES, adverse effects within 48 hours after extubation, hospital length of stay and hospital mortality.Discussion: Patients who are intubated on an emergency basis have a higher risk of intubation-related complications. Previous studies have examined treatment regimens involving more than 10 different variations on corticosteroid treatments for PES prevention, while for ED therapy only a simple and effective treatment would be appropriate. Corticosteroid administration is usually accompanied by adverse effects, thus this study will be important for further risk stratification among intubated ED patients. Trial registration: Chictr.org.cn, ChiCTR2000030349. Registered on 29 Feb 2020.

Effect of Early versus Late Tracheostomy Placement on Survival in Patients Receiving Mechanical Ventilation

2018 ◽  
pp. 157-162
Author(s):  
J. Michael Guthrie ◽  
Vadim Gudzenko
Keyword(s):  
Mechanical Ventilation ◽  
Prolonged Mechanical Ventilation ◽  
Controlled Trial ◽  
Hospital Length ◽  
Hospital Length Of Stay ◽  
Icu Patients ◽  
Early Tracheostomy ◽  
Mechanically Ventilated ◽  
Study Intervention

The TracMan randomized controlled trial examined mortality among patients randomized to receive early (first 4 days) versus late (after 10 days) tracheostomy. This chapter describes the basics of the study, including funding, study location, who was studied, how many patients, study design, study intervention, follow-up, endpoints, results, and criticism and limitations. It briefly reviews other relevant studies and information, discusses implications, and concludes with a relevant clinical case. The study found that early tracheostomy did not improve mortality in mechanically ventilated ICU patients. Early tracheostomy did not improve important patient outcomes such as ICU or hospital length of stay. The study also demonstrated that clinicians’ ability to predict which ICU patients will require prolonged mechanical ventilation is severely limited.

scholarly journals Efficacy of prophylactic methylprednisolone on reducing the risk of post-extubation stridor in an emergency setting: study protocol for a randomized controlled trial

2020 ◽  
Author(s):  
Jingyi Wang ◽  
Joseph Harold Walline ◽  
Lu Yin ◽  
Yili Dai ◽  
Jiayuan Dai ◽  
...  
Keyword(s):  
Adverse Effects ◽  
Controlled Trial ◽  
Extubation Failure ◽  
Time Frame ◽  
Hospital Length ◽  
Hospital Length Of Stay ◽  
Respiratory Support ◽  
Emergency Setting ◽  
Emergency Intubation ◽  
Cuff Leak

Abstract Background: Post-extubation stridor (PES) is one of common complications of invasive respiratory support, with severe cases leading to extubation failure (need reintubation within 48 hours after extubation) and increased mortality. Previous studies confirmed that prophylactic corticosteroids play an important role in reducing the risk of PES and extubation failure. However, few study the efficacy of corticosteroid on preventing PES in patients with an emergency intubation. Aim: To evaluate whether a single dose of methylprednisolone given over a set time-frame before extubation is effective in preventing PES in patients with an emergency intubation. Methods: A multicenter, randomized, placebo-controlled trial will be performed. The trial will include 242 patients who fail the cuff-leak test (CLT) in the intervention. The patients will be randomly assigned to either intravenous methylprednisolone 40mg or placebo four hours prior to extubation. Other eligible patients who pass the CLT will be included in non-intervention (observation). The primary endpoint is the incidence of PES within 48 hours after extubation, the secondary endpoints are the oxygen therapy, requirement for respiratory support, reintubation secondary to PES, adverse effects within 48 hours after extubation, hospital length of stay and hospital mortality.Discussion: Patients who are intubated on an emergency basis have a higher risk of intubation-related complications due to some inevitable reasons. Earlier studies showed more than 10 different corticosteroids treatments on PES prevention, while only a simple and effective treatment will be appropriate for Emergency Department therapy. Additionally, corticosteroids administration is usually companied by adverse effects, thus the recording of adverse effects is important for further pros and cons analysis of prophylactic corticosteroid use among emergency patients. Trial registration: Chictr.org.cn, ChiCTR2000030349. Registered on 29 Feb 2020.

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