Evaluation of the Diaphragm Performance During Weaning From Mechanical Ventilation

January 11, 2024 updated by: Mhamed Sami Mebazaa, Mongi Slim Hospital

Evaluation of the Diaphragm Tissue Doppler Parameters in Predicting Weaning From Mechanical Ventilation Outcome

Prospective observationnal study, including ICU adult patients with invasive mechanical ventilation for at least 48 hours. Patients are included when performing weaning from mechanical ventilation with pressure support (lowest level of pressure support).

Before separating the patient from the ventilator and performing a T tube spontaneous breathing test, diaphragm ultrasound is performed bilaterally : diaphragm excursion, diaphragm thickening fraction and maximal contraction and relaxation velocities with tissue doppler imaging.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This observationnal study will include patients during weaning from invasive mechanical ventilation: ventilation in pressure support with the lowest level With normal neurological status: glasgow coma scale > 13 Requiring no vasopressor support

conventionnal diaphragm parameters: diaphram excursion and thickening fraction will be collected bilaterally with the tissue doppler measures: maximal contraction and relaxation velocities, immediately before a T Tube test.

Patients will be divided into 2 groups according to their weaning from mechanicla ventilation outcome, and diaphragm ultrasound patterns will be compared between the 2 groups in order to evaluate the performance of tissue doppler in predicting weaning outcome.

Study Type

Observational

Enrollment (Estimated)

50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Tunisia
      • Tunis, Tunisia, 2085
        • Recruiting
        • Mongi Slim hospital
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients undergoing weaning from mechanical ventilation: Pressure support ventilation with the lowest level of support Glasgow coma scale of at least 13 Hemodynamic stability with no vasopressors

Description

Inclusion Criteria:

  • Invasive mechanical ventilation for at least 48 hours

Exclusion Criteria:

  • reintubation for extra respiratory failure (neurologic or hemodynamic)
  • Patients with chronic repiratory failure

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
weaning success
Patients extubated with no need to non invasive ventilatry support during 48 hours
Diagnostic test: diaphragm ultrasound monitoring
Ultrasound measure the diaphragm excursion, thickening fraction and maximal contraction and relaxation velocities
weaning failure
patients requiring reintubation or non invasive ventilation within 48 hours after extubation
Diagnostic test: diaphragm ultrasound monitoring
Ultrasound measure the diaphragm excursion, thickening fraction and maximal contraction and relaxation velocities

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
weaning from mechanical ventilation success
Time Frame: Day 2
no need of non invasive ventilation or reintubation
Day 2

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mongi Slim Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2023

Primary Completion (Estimated)

November 30, 2024

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

December 28, 2023

First Submitted That Met QC Criteria

January 11, 2024

First Posted (Actual)

January 12, 2024

Study Record Updates

Last Update Posted (Actual)

January 12, 2024

Last Update Submitted That Met QC Criteria

January 11, 2024

Last Verified

December 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • Diaphram Tissue Doppler

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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