Diaphragm Ultrasound to Predict Weaning Outcomes in Mechanically Ventilated Patients

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.

Study Overview

• Status: Completed
• Conditions: Accuracy of DE and DTF in Prediction of Extubation Success
• Intervention / Treatment: Diagnostic test: comparaison between DE and DTF in prediction of extubation success

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: Observational
• Enrollment (Actual): 36

Contacts and Locations

Study Locations

• Tunisia
  • Tunis
    • La Marsa, Tunis, Tunisia, 2046
      • Mongi Slim Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All adult patients who were mechanically ventilated for more than 48 hours and meeting all extubation criteria without a history of neuromuscular disease or severe chronic respiratory failure

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	comparaison between DE and DTF values in successfully extubated patients	48 hours after extubation

Collaborators and Investigators

• Sponsor: Mongi Slim Hospital
• Investigators: Principal Investigator: Mhamed Sami Mebazaa, Professor, Mongi Slim Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2017
• Primary Completion (Actual): December 31, 2017
• Study Completion (Actual): December 31, 2017

Study Registration Dates

• First Submitted: March 22, 2018
• First Submitted That Met QC Criteria: March 22, 2018
• First Posted (Actual): March 29, 2018

Study Record Updates

• Last Update Posted (Actual): March 30, 2018
• Last Update Submitted That Met QC Criteria: March 28, 2018
• Last Verified: March 1, 2018

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)?: 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