Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT06154811 |
Other study ID # |
269089632 |
Secondary ID |
|
Status |
Recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
September 1, 2022 |
Est. completion date |
December 2024 |
Study information
Verified date |
December 2023 |
Source |
Affiliated Hospital of Jiangnan University |
Contact |
Jun Liu, Master |
Phone |
+8617751500920 |
Email |
17751500920[@]sina.cn |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
Determining the appropriate extubation timing for mechanically ventilated patients is a
critical issue in the Intensive Care Unit (ICU). Early or delayed extubation may prolong
mechanical ventilation and ICU stay, leading to an increased mortality rate. Currently,
extubation timing relies solely on the Spontaneous Breathing Trial (SBT), but its reliability
is relatively low, with a extubation failure rate ranging from 10% to 40%. Therefore,
accurately predicting potential post-extubation issues and early identification of reasons
for SBT trial failure are crucial for improving patient outcomes. Commonly used parameters
for assessing readiness for extubation do not fully reflect organ dysfunction, and the
investigators plan to utilize comprehensive techniques, including bedside lung and diaphragm
ultrasound parameters, to enhance the accuracy of predicting extubation outcomes in patients
who pass the SBT trial.
Description:
All patients included in the study underwent a spontaneous breathing trial (SBT) using
pressure support ventilation (PSV) strategy. This strategy employed pressure support(PS)≤9
cmH2O and positive end-expiratory pressure (PEEP)≤5 cmH2O. The duration of the trial was 30
minutes, and the FiO2 level was set at the same level (≤0.5) used during mechanical
ventilation. After successful completion of the spontaneous breathing trial (SBT), ultrasound
images were promptly acquired, and the Rapid Shallow Breathing Index (RSBI) was calculated
based on the values displayed by the ventilator . Simultaneously, the Acute Physiology and
Chronic Health Evaluation II (APACHE II) score was computed and recorded. The decision to
extubate, made by the attending physician (unaware of the ultrasound examination parameters),
was based on clinical judgment. The primary endpoint event was extubation failure, defined as
successful completion of SBT but an inability to sustain spontaneous breathing for more than
48 hours without noninvasive or invasive ventilation support.