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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
50
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.
The first affiliated hospital of SunYatSen University
Guanzhou, Guangdong, China
RECRUITINGExtubation success rate
The success rate of extubation (during 48 hours after the first SBT if successfully removed from the ventilator).
Time frame: during 48 hours after the first SBT
Reintubation rate
The reintubation rate of respiratory failure after extubation.
Time frame: during 48 hours after extubation
Reintubation rate at 72 hours
Reintubation rate at 72 h
Time frame: during 72 hours after extubation
No mechanical ventilation duration in ICU
No mechanical ventilation duration in ICU
Time frame: From first transfer in ICU to transfer out ICU up to 28 days after randomization
Length of ICU stay
Length of ICU stay
Time frame: From admission to discharge from ICU up to 28 days after randomization
ICU mortality, 28-day mortality
ICU mortality, 28-day mortality
Time frame: 28 day
Results of blood gas analysis
PaCO2 and PaO2 (SBT screening, SBT completion, 30min after extubation)
Time frame: every 30 min during SBT up one hour to and 30min after extubation
Respiratory mechanical parameters
lung compliance monitoring: Static and dynamic lung compliance
Time frame: every 30 min during SBT up to one hour
Predictors of withdrawal of patients on mechanical ventilation
airway occlusion pressure
Time frame: every 30 min during SBT up one hour and before extubation
Predictors of withdrawal of patients on mechanical ventilation
negativeinspiratory force
Time frame: every 30 min during SBT up one hour and before extubation
Predictors of withdrawal of patients on mechanical ventilation
Rapid Shallow Breathing Index
Time frame: every 30 min during SBT up to one hour and before extubation
Vital signs
Heart Rate
Time frame: every 15 min during SBT up to one hour and 30 min after extubation
Vital signs
SpO2
Time frame: every 15 min during SBT up to one hour and 30 min after extubation
Vital signs
Blood Pressure
Time frame: every 15 min during SBT up to one hour and 30 min after extubation
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