Clinical Trial Details
— Status: Recruiting
Administrative data
| NCT number |
NCT05632822 |
| Other study ID # |
K2603 |
| Secondary ID |
|
| Status |
Recruiting |
| Phase |
|
| First received |
|
| Last updated |
|
| Start date |
September 1, 2022 |
| Est. completion date |
January 1, 2023 |
Study information
| Verified date |
November 2022 |
| Source |
Peking Union Medical College Hospital |
| Contact |
Shitong Diao, Dr |
| Phone |
13833117878 |
| Email |
diaost[@]foxmail.com |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Observational
|
Clinical Trial Summary
The reason of failure of weaning from mechanical ventilation is that their respiratory loads
exceeding the capacity of their respiratory muscles. The electric activity of diaphragm
(EADI) allows quantification of the neural respiratory drive to the diaphragm. The aim of
this study is to evaluate diaphragmatic ultrasound related parameters and electric activity
of diaphragm (EADI) during SBT and postural changes to predict weaning outcome.
Description:
The reason of failure of weaning from mechanical ventilation is that their respiratory loads
exceeding the capacity of their respiratory muscles. The aim of this study is to evaluate
diaphragmatic ultrasound related parameters and electric activity of diaphragm (EADI) during
SBT and postural changes to predict weaning outcome. EADI catheter consists of a nasogastric
feeding tube equipped with a multiple-array esophageal electrode that provides real time
access to EADI.
Patients intubated and ventilated for at least 48 h were eligible for inclusion in the study.
After the ward physician judged that the patients' condition met the offline standard,
patients were prepared to conduct spontaneous breathing trial (SBT). All recruited patients
were placed EADI catheter.
The protocol started with patients ventilated on a PSV of 10 cm H2O above a positive
end-expiratory pressure (PEEP) of 4-5 cm H2O. Then record ventilator parameters, EADI
parameters (including maximum EADI, minimum EADI, area under the curve of the EADI during
inspiratory time) and diaphragmatic ultrasound related parameters (diaphragm thickness and
diaphragm displacement) respectively in the semi-seated and supine positions. Then assist was
removed and a 30-minute SBT was performed with continuous positive airway pressure (CPAP) of
4-5 cm H2O at the previous level of FiO2. At 0, 1, 5, 10, 20 and 30 minutes into the SBT
vital signs, ventilatory parameters (including RR, Vt, Ppeak, PEEP, P0.1, MV) were collected.
Arterial blood gases were sampled at the start and the end of the SBT.
The SBT was considered to be a failure if at least one the following criteria was present:
(1) blood oxygen saturation (SpO2) of <90 % with a fraction of inspired oxygen (FiO2) of≥50
%; (2) acute respiratory distress (RR≥40/min, agitation, cyanosis); (3) systolic arterial
blood pressure of ≥180 mmHg; (4) cardiac arrhythmias; (5) respiratory acidosis [pH<7.32 with
an arterial carbon dioxide tension (PaCO2) of ≥50 mmHg]. If none of these failure criteria
was present, the SBT was considered as successfully completed.
Patient was reconnected if signs of intolerance were present. The separation from the
ventilator and the endotracheal tube was considered a success when spontaneous breathing
could be sustained without any form of ventilatory support at 48h after extubation. Failure
cases included patients who failed the SBT and patients requiring reintubation or any form of
ventilator support (including non-invasive ventilation for post-extubation acute respiratory
failure) during the first 48 h after extubation.
