NCT06321848

Brief 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.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
190

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2024

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 27, 2024

Completed
22 days until next milestone

First Posted

Study publicly available on registry

March 20, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

April 22, 2024

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2026

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2026

Completed
Last Updated

February 3, 2026

Status Verified

February 1, 2026

Enrollment Period

1.9 years

First QC Date

February 27, 2024

Last Update Submit

February 1, 2026

Conditions

Keywords

echocardiographylung ultrasounddiaphragm ultrasoundventilator weaning

Outcome Measures

Primary Outcomes (1)

  • The ventilator weaning outcome

    The outcome of weaning ventilation process (successful or failure)

    after 48 hours of extubation

Secondary Outcomes (3)

  • The hospital length of stay

    Approximately 5-15 days postextubation

  • The ICU length of stay

    Approximately 2-15 days postextubation

  • The duration of mechanical ventilation

    Daily assessment of requirement of mechanical ventilation from the time of intubation until the date of weaning mechanical ventilation, up to 12 months

Study Arms (1)

The ventilator weaning patients

Patients who have been on mechanical breathing for longer than 48 hours using an endotracheal tube and who fit the requirements to be weaned off of it

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients with a duration of mechanical ventilation through an endotracheal tube of more than 48 hours and meeting the criteria of readiness to wean off mechanical ventilation will be included in the study.

You may qualify if:

  • Age \>= 18
  • The duration of postoperative mechanical ventilation \>= 48 hours

You may not qualify if:

  • Patient had a diagnosis of progressive neuromuscular diseases
  • Patient had a history of cardiovascular or respiratory disease who depend on a ventilator at home (COPD, severe bronchial asthma)
  • Patients had thoracic surgery or mitral valve surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hanoi Medical University Hospital

Hanoi, 100000, Vietnam

RECRUITING

Study Officials

  • Tu Nguyen, Professor

    Hanoi Medical University

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Target Duration
30 Days
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 27, 2024

First Posted

March 20, 2024

Study Start

April 22, 2024

Primary Completion

March 1, 2026

Study Completion

April 1, 2026

Last Updated

February 3, 2026

Record last verified: 2026-02

Data Sharing

IPD Sharing
Will share

The investigators agree that all results and conclusion of this research will be used fully for other researchers

Shared Documents
STUDY PROTOCOL, ICF, CSR
Time Frame
from March 2026 to the unidentified time
Access Criteria
anesthesiologists all over the world

Locations