Diaphragm Ultrasound to Predict Weaning Outcomes in Mechanically Ventilated Patients

• Sponsor: Mongi Slim Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT03480828
• Collaborator: (none)
• Enrollment: 36
• Location: 1
• Actual Duration (Months): 9
• Patients Per Site Per Month: 4

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Accuracy of DE and DTF in Prediction of Extubation Success	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 Design

• Study Type: Observational
• Actual Enrollment: 36 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Diaphragm Ultrasound to Predict Weaning Outcomes in Mechanically Ventilated Patients
• Actual Study Start Date: Apr 1, 2017
• Actual Primary Completion Date: Dec 31, 2017
• Actual Study Completion Date: Dec 31, 2017

Outcome Measures

Primary Outcome Measures

1. extubation success [48 hours after extubation]

   comparaison between DE and DTF values in successfully extubated patients

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mongi Slim Hospital	La Marsa	Tunis	Tunisia	2046

Sponsors and Collaborators

• Mongi Slim Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Mhamed Sami Mebazaa, Professor head of the anesthesia and intensive care department, Mongi Slim Hospital
• ClinicalTrials.gov Identifier: NCT03480828
• Other Study ID Numbers: rea1
• First Posted: Mar 29, 2018
• Last Update Posted: Mar 30, 2018
• Last Verified: Mar 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Mar 30, 2018