Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT06321848 |
Other study ID # |
DUCGM2426 |
Secondary ID |
|
Status |
Recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
April 22, 2024 |
Est. completion date |
April 2026 |
Study information
Verified date |
May 2024 |
Source |
Hanoi Medical University |
Contact |
Duc Tran, MD |
Phone |
+84983817388 |
Email |
ductran.hmu[@]gmail.com |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational [Patient Registry]
|
Clinical Trial Summary
Postextubation distress is detrimental to the prognosis of critically ill patients with
successful spontaneous breathing trial. Failure to wean is known to be connected with heart,
lung, and diaphragm problems. The aim of this study was to investigate how a composite model
comprising diaphragm, lung, and heart ultrasonography indications could predict the weaning
outcome.
Methods: Ultrasonic features of the diaphragm, heart, and lungs are going to be collected
along with clinical data about the patients. Either the successful weaning group or the
failed weaning group is going to comprised the patients. Multivariate logistic regression
analysis is going to be used to identify the variables that may be associated with the
likelihood of weaning failure. A multiindicator combination model is going to be developed to
increase the predictive accuracy after the possible indicators' accuracy in foretelling the
weaning outcome was assessed.
Description:
- Research participants: From March 2024 to March 2026 in the Department of Anesthesia,
critical care and pain medicine, Hanoi Medical University Hospital, patients ages over 18
years who will have mechanically ventilated for over 48 h will be recruited. Patients will be
excluded if they had a diagnosis of progressive neuromuscular diseases, a history of
cardiovascular or respiratory disease who depend on a ventilator at home (COPD, severe
bronchial asthma), patients with thoracic surgery and mitral valve surgery. All patients and
their families signed informed consents.
- Clinical data collection: Clinical data including gender, age, body mass index, primary
disease, length of stay in ICU, duration of mechanical ventilation, acute physiology and
chronic health evaluation II, Charlson Comorbidity Index, history of surgery/internal
diseases will be collected.
- Spontaneous breathing trial (SBT): Patients will be undergone a 60-min SBT when they meet
all the readiness weaning criteria with PS 7cmH2O, PEEP 5cmH2O, FiO2 40%. The vital signs,
rapid shallow breathing index (RSBI), NIF, P0.1, tidal volume, respiratory rate, arterial
blood gases will be recorded at the beginning and at the end of SBT.
GE Logiq P7 (GE Healthcare, USA) and Philips Affiniti 70G (Philips Ultrasound, USA)
ultrasound diagnostic instruments will be used in this study. The heart, lung and diagphragm
ultrasonic findings will be recorded by the sonographer well trained in point-of-care
ultrasound at the begining and at the end of the SBT.
Tracheal extubation is carried out if the patient does not exhibit symptoms of intolerance,
indicating that the SBT treatment was successful. In case intolerance symptoms manifest,
return to the initially chosen breathing mode (SIMV, A/C) and record the SBT failure.
- Extubation: After successful SBT: proceed with extubation. The patient is given an oxygen
mask at 5L/minute. If the patient does not show intolerance symptoms within 48 hours, the
extubation is considered successful. If the patient develops one of the intolerance symptoms
during this time period, the extubation failure will be recorded and the patients will be
reintubated. Record the values of vital signs and arterial blood gas variables every 24, 48
hours after extubation.