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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03480828
Other study ID # rea1
Secondary ID
Status Completed
Phase
First received March 22, 2018
Last updated March 28, 2018
Start date April 1, 2017
Est. completion date December 31, 2017

Study information

Verified date March 2018
Source Mongi Slim Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 36
Est. completion date December 31, 2017
Est. primary completion date December 31, 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms

  • Accuracy of DE and DTF in Prediction of Extubation Success

Intervention

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

Locations

Country Name City State
Tunisia Mongi Slim Hospital La Marsa Tunis

Sponsors (1)

Lead Sponsor Collaborator
Mongi Slim Hospital

Country where clinical trial is conducted

Tunisia, 

Outcome

Type Measure Description Time frame Safety issue
Primary extubation success comparaison between DE and DTF values in successfully extubated patients 48 hours after extubation