- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03480828
Diaphragm Ultrasound to Predict Weaning Outcomes in Mechanically Ventilated Patients
Study Overview
Status
Intervention / Treatment
Detailed Description
This trial enrolled all the adult patients who were mechanically ventilated for more than 48 hours and met all creteria for extubation. Patients who needed reintubation for upper aiway obstruction, neurological or hemodynamic alteration were excluded. The diaphragm ultrasound was performed during spontaneous breathing test or pressure support ventilation trial measuring the dipahragmatic excursion (DE) and the diaphragm thickening fraction (DTF) whithin 24 hours before extubation. The investigators compared the median values of DE and DTF in the group of successfully extubated patients and the group of patients who needed reintubation.
Our study compared the utility of DTF and DE to predict extubation success.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Tunis
-
La Marsa, Tunis, Tunisia, 2046
- Mongi Slim hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- patients who were mechanically ventilated for more than 48h and meeting all criteria for extubation
- patients without history of neuromuscular disease, or severe chronic respiratory failure
Exclusion Criteria:
- patients who needed reintubation for upper airway obstruction or neurological or hemodynamic instability
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
extubation success
Time Frame: 48 hours after extubation
|
comparaison between DE and DTF values in successfully extubated patients
|
48 hours after extubation
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Mhamed Sami Mebazaa, Professor, Mongi Slim hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- rea1
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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