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Diaphragm Ultrasound to Predict Weaning Outcomes in Mechanically Ventilated Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03480828
Recruitment Status : Completed
First Posted : March 29, 2018
Last Update Posted : March 30, 2018
Sponsor:
Information provided by (Responsible Party):
Mhamed Sami Mebazaa, Mongi Slim Hospital

Study Description
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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
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
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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 : April 1, 2017
Actual Primary Completion Date : December 31, 2017
Actual Study Completion Date : December 31, 2017
Groups and Cohorts
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Intervention Details:
  • Diagnostic Test: comparaison between DE and DTF in prediction of extubation success
    diaphragm ultrasound and measurement of DE and DTF in patients meeting all extubation criteria during spontaneous breathing trial

Outcome Measures
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Primary Outcome Measures :
  1. extubation success [ Time Frame: 48 hours after extubation ]
    comparaison between DE and DTF values in successfully extubated patients


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03480828


Locations
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Tunisia
Mongi Slim Hospital
La Marsa, Tunis, Tunisia, 2046
Sponsors and Collaborators
Mongi Slim Hospital
Investigators
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Principal Investigator: Mhamed Sami Mebazaa, Professor Mongi Slim Hospital
More Information
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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: March 29, 2018    Key Record Dates
Last Update Posted: March 30, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No