Respiration, Artificial
Conditions
Keywords
PEEP, pressure support ventilation, SBT
Brief summary
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
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.
Interventions
PROCEDUREPEEP
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.
Sponsors
First Affiliated Hospital, Sun Yat-Sen University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Extubation success rate | during 48 hours after the first SBT | The success rate of extubation (during 48 hours after the first SBT if successfully removed from the ventilator). |
| Reintubation rate | during 48 hours after extubation | The reintubation rate of respiratory failure after extubation. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| No mechanical ventilation duration in ICU | From first transfer in ICU to transfer out ICU up to 28 days after randomization | No mechanical ventilation duration in ICU |
| Length of ICU stay | From admission to discharge from ICU up to 28 days after randomization | Length of ICU stay |
| ICU mortality, 28-day mortality | 28 day | ICU mortality, 28-day mortality |
| Respiratory mechanical parameters | every 30 min during SBT up to one hour | lung compliance monitoring： Static and dynamic lung compliance |
| Predictors of withdrawal of patients on mechanical ventilation | every 30 min during SBT up one hour and before extubation | airway occlusion pressure |
| Vital signs | every 15 min during SBT up to one hour and 30 min after extubation | Heart Rate |
| Results of blood gas analysis | every 30 min during SBT up one hour to and 30min after extubation | PaCO2 and PaO2 (SBT screening, SBT completion, 30min after extubation) |
| Reintubation rate at 72 hours | during 72 hours after extubation | Reintubation rate at 72 h |
Other
| Measure | Time frame | Description |
|---|---|---|
| Chest electrical impedance imaging (EIT) | from the start to the end of SBT up to one hour and 30min after extubation | region of interests(RI),Center of Ventilation(COV),end expiratory lung inmpedance(EELI), △EELi |
| Subjective score of patients with dyspnea | every 30 min during SBT up to one hour and 30min after extubation | Score 0-10: 0 for no dyspnea, 10 for severe dyspnea |
Countries
China
Contacts
Primary ContactZiMeng Liu, Doctor
Outcome results
None listed