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 ◽  
...  

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.

Trials ◽  
2021 ◽  
Vol 22 (1) ◽  
Author(s):  
Jingyi Wang ◽  
Joseph Harold Walline ◽  
Lu Yin ◽  
Yili Dai ◽  
Jiayuan Dai ◽  
...  

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.


2020 ◽  
Author(s):  
Jingyi Wang ◽  
Joseph Harold Walline ◽  
Lu Yin ◽  
Yili Dai ◽  
Jiayuan Dai ◽  
...  

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.


2020 ◽  
Author(s):  
Jingyi Wang ◽  
Joseph Walline ◽  
Yili Dai ◽  
Lu Yin ◽  
Jiayuan Dai ◽  
...  

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.


Author(s):  
RIO RAHMADI ◽  
NUR RASYID ◽  
PONCO BIROWO

Objective: This study was designed to compare the efficacy and safety of the supine and prone positions in percutaneous nephrolithotomies (PCNLs) used for the treatment of kidney stones in Indonesian patients. Methods: This was a single-blinded randomized controlled trial of those patients undergoing PCNLs from February to May of 2018. There were 19 subjects in the supine group and 19 in the prone group for a total of 38 study subjects. The study outcomes that were compared included the operative time, hospital length of stay (LOS), stone-free rate, blood loss, conversion to open surgery, blood transfusion, and complications. These outcomes were evaluated using the Student’s t test and the chi-squared test. Results: There were no significant differences in the patient demographics or stone locations between the two groups. Additionally, the medians of the operative times, LOSs, blood losses, and blood transfusions were not statistically different. There was a higher stone-free rate in the supine group than in the prone group (70.0% vs. 47.4%, respectively, p = 0.151). More subjects were transfused in the supine group (30.0%) than in the prone group (15.8%), but this difference was not statistically significant (p = 0.292). The only complications were infundibular lacerations, which occurred in 20% of the subjects in the supine group and 15.8% of the subjects in the prone group (p = 0.732). Conclusion: This study showed that the supine and prone positions for PCNLs had similar efficacy and safety outcomes.


2018 ◽  
Vol 17 (8) ◽  
pp. 751-759 ◽  
Author(s):  
Gianfranco Sanson ◽  
Massimiliano Sartori ◽  
Lorella Dreas ◽  
Roberta Ciraolo ◽  
Adam Fabiani

Background: Extubation failure (ExtF) is associated with prolonged hospital length of stay and mortality in adult cardiac surgery patients postoperatively. In this population, ExtF-related variables such as the arterial partial pressure of oxygen to fraction of inspired oxygen ratio (PaO2/FiO2), rapid shallow breathing index, cough strength, endotracheal secretions and neurological function have been sparsely researched. Aim: To identify variables that are predictive of ExtF and related outcomes. Method: Prospective observational longitudinal study. Consecutively presenting patients ( n=205) undergoing open-heart cardiac surgery and admitted to the Cardiosurgical Intensive Care Unit (CICU) were recruited. The clinical data were collected at CICU admission and immediately prior to extubation. ExtF was defined as the need to restart invasive or non-invasive mechanical ventilation while the patient was in the CICU. Results: The ExtF incidence was 13%. ExtF related significantly to hospital mortality, CICU length of stay and total hospital length of stay. The risk of ExtF decreased significantly, by 93% in patients with good neurological function and by 83% in those with a Rapid Shallow Breathing Index of ≥57 breaths/min per litre. Conversely, ExtF risk increased 27 times when the PaO2/FiO2 was <150 and 11 times when it was ≥450. Also, a reassuring PaO2/FiO2 value may hide critical pulmonary or extra-pulmonary conditions independent from alveolar function. Conclusion: The decision to extubate patients should be taken after thoroughly discussing and combining the data derived from nursing and medical clinical assessments. Extubation should be delayed until the patient achieves safe respiratory, oxygenation and haemodynamic conditions, and good neurocognitive function.


Trials ◽  
2020 ◽  
Vol 21 (1) ◽  
Author(s):  
Ximena Cid ◽  
David Canty ◽  
Alistair Royse ◽  
Andrea B. Maier ◽  
Douglas Johnson ◽  
...  

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.


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