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CompletedNCT03480828Updated Mar 30, 2018

Diaphragm Ultrasound to Predict Weaning Outcomes in Mechanically Ventilated Patients

An observational study in Accuracy of DE and DTF in Prediction of Extubation Success, sponsored by Mongi Slim Hospital. Completed at 1 site in Tunisia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-03-30.

Sponsored by Mongi Slim Hospital · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
36
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Accuracy of DE and DTF in Prediction of Extubation Success
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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

Exclusion Criteria:

  • patients who needed reintubation for upper airway obstruction or neurological or hemodynamic instability
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
36 participants (actual)
Patient registry
No

Interventions

  • Diagnostic testcomparaison 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

05

What researchers measure

Primary outcomes

  1. extubation success

    comparaison between DE and DTF values in successfully extubated patients

    Time frame: 48 hours after extubation

06

Study locations

1 site
  • Mongi Slim Hospital
    La Marsa, Tunis 2046, Tunisia
07

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03480828
Lead sponsor
Mongi Slim Hospital
Responsible party
Mhamed Sami Mebazaa (Professor head of the anesthesia and intensive care department, Mongi Slim Hospital) — Principal investigator
First posted
Mar 29, 2018
Start date
Apr 1, 2017
Primary completion
Dec 31, 2017
Completion
Dec 31, 2017
Last update
Mar 30, 2018

Study contacts

Mhamed Sami Mebazaa, Professor
principal investigator · Mongi Slim Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Mar 2018. You cannot join it, but the record below documents what was studied.

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