Effect of PEEP=5cmH2O vs PEEP=0cmH2O PSV Strategies During SBT on Successful Disconnection From Mechanical Ventilation

Study Overview
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Brief Summary
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Mechanical ventilation is the most common means of life support in intensive care unit. Daily spontaneous breathing trial (SBT) is the most effective method to evaluate whether patients on mechanical ventilation can be removed from the ventilator, thus reducing mechanical ventilation duration and ventilator-related complications. Pressure support ventilation and T-piece ventilation are the two most commonly used SBT methods, lasting from 30 minutes to 2 hours. However, the parameter setting for SBT using PSV method has not been completely agreed, especially regarding the use of positive end-expiratory pressure (PEEP). Therefore, we intend to conduct a single-center, prospective, randomized, controlled study to evaluate the impact of PEEP=0cmH2O and PEEP=5cmH2O on extubation success rate and re-intubation rate in mechanically ventilated patients, to provide high-level clinical evidence on the use of PEEP for SBT in patients with mechanical ventilation, so as to reduce the duration of mechanical ventilation and complications related to mechanical ventilation.

Detailed Description
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Patients who met the withdrawal screening criteria were randomly divided into groups for self-breathing test by PSV method with low pressure support level. Parameters of each group were as follows. In the experimental group, PS = 8 cmH2O, PEEP= 5 cmH2O, and FiO2 level was consistent with that before SBT.The control group: PSV mode, PS = 8 cmH2O, PEEP=0 cmH2O, FiO2 level was consistent with that before SBT.The duration of the spontaneous breathing test was 30 minutes, and the results of the spontaneous breathing test were evaluated at the end of the test.Endotracheal intubation was removed if the patient was successfully assessed for spontaneous breathing. Record the date and time of extubation.Patients with endotracheal intubation were treated with nasal hyperflow oxygen therapy for respiratory support.Patients with SBT failure were reconnected to the ventilator, and mechanical ventilation was given according to the ventilation mode and parameters before the spontaneous breathing test.The reasons for SBT failure were recorded and these patients were not randomized to SBT.If respiratory failure occurs within 48 hours after extubation, the attending physician decides the respiratory treatment plan.These patients were also not included in the subsequent SBT randomization.

Official Title
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Effect of PEEP=5cmH2O vs PEEP=0cmH2O PSV Strategies During SBT on Successful Disconnection From Mechanical Ventilation: A Randomized Clinical Trial

Conditions
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Respiration, Artificial

Intervention / Treatment
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* Procedure: PEEP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 1) Older than 18; 2) Patients with mechanical ventilation for 24h; 3) Meet the screening standards for daily disconnection; 4) The study complies with the Declaration of Helsinki and China's regulations on clinical trial research, and the patient or his/her family members have informed and agreed to participate in the study. Exclusion Criteria: 1) Patients undergoing tracheotomy; 2) Patients who refuse to be intubated again after endotracheal intubation is removed; 3) Patients on long-term mechanical ventilation: mechanical ventilation duration was continuous for 21 days, >6 h/d; 4) The attending physician decides the withdrawal plan (e.g., the potential pathology is more favorable to the specific withdrawal plan).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PEEP=5cmH2O<br>In PSV mode,PS = 8 cmH2O,PEEP= 5 cmH2O, and FiO2 level was consistent with that before SBT | Procedure: PEEP<br>* The patients who met the withdrawal screening criteria were randomly divided into low pressure support level PSV spontaneous respiration test.The duration of the spontaneous breathing test was 30 minutes, and the results of the spontaneous breathing test were evaluated at the end of the test.<br>|
| Experimental: PEEP=0cmH2O<br>In PSV mode,PS = 8 cmH2O,PEEP=0 cmH2O, and FiO2 level was consistent with that before SBT | Procedure: PEEP<br>* The patients who met the withdrawal screening criteria were randomly divided into low pressure support level PSV spontaneous respiration test.The duration of the spontaneous breathing test was 30 minutes, and the results of the spontaneous breathing test were evaluated at the end of the test.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Extubation success rate | The success rate of extubation (during 48 hours after the first SBT if successfully removed from the ventilator). | during 48 hours after the first SBT | 
| Reintubation rate | The reintubation rate of respiratory failure after extubation. | during 48 hours after extubation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reintubation rate at 72 hours | Reintubation rate at 72 h | during 72 hours after extubation | 
| No mechanical ventilation duration in ICU | No mechanical ventilation duration in ICU | From first transfer in ICU to transfer out ICU up to 28 days after randomization | 
| Length of ICU stay | Length of ICU stay | From admission to discharge from ICU up to 28 days after randomization | 
| ICU mortality, 28-day mortality | ICU mortality, 28-day mortality | 28 day | 
| Results of blood gas analysis | PaCO2 and PaO2 (SBT screening, SBT completion, 30min after extubation) | every 30 min during SBT up one hour to and 30min after extubation | 
| Respiratory mechanical parameters | lung compliance monitoring： Static and dynamic lung compliance | every 30 min during SBT up to one hour | 
| Predictors of withdrawal of patients on mechanical ventilation | airway occlusion pressure | every 30 min during SBT up one hour and before extubation | 
| Predictors of withdrawal of patients on mechanical ventilation | negativeinspiratory force | every 30 min during SBT up one hour and before extubation | 
| Predictors of withdrawal of patients on mechanical ventilation | Rapid Shallow Breathing Index | every 30 min during SBT up to one hour and before extubation | 
| Vital signs | Heart Rate | every 15 min during SBT up to one hour and 30 min after extubation | 
| Vital signs | SpO2 | every 15 min during SBT up to one hour and 30 min after extubation | 
| Vital signs | Blood Pressure | every 15 min during SBT up to one hour and 30 min after extubation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PEEP, pressure support ventilation, SBT