Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06203353
Other study ID # Diaphram Tissue Doppler
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date November 1, 2023
Est. completion date December 30, 2024

Study information

Verified date December 2023
Source Mongi Slim Hospital
Contact Mhamed Mebazaa, professor
Phone 22252589
Email msmebazaa@gmail.com
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Prospective observationnal study, including ICU adult patients with invasive mechanical ventilation for at least 48 hours. Patients are included when performing weaning from mechanical ventilation with pressure support (lowest level of pressure support). Before separating the patient from the ventilator and performing a T tube spontaneous breathing test, diaphragm ultrasound is performed bilaterally : diaphragm excursion, diaphragm thickening fraction and maximal contraction and relaxation velocities with tissue doppler imaging.


Description:

This observationnal study will include patients during weaning from invasive mechanical ventilation: ventilation in pressure support with the lowest level With normal neurological status: glasgow coma scale > 13 Requiring no vasopressor support conventionnal diaphragm parameters: diaphram excursion and thickening fraction will be collected bilaterally with the tissue doppler measures: maximal contraction and relaxation velocities, immediately before a T Tube test. Patients will be divided into 2 groups according to their weaning from mechanicla ventilation outcome, and diaphragm ultrasound patterns will be compared between the 2 groups in order to evaluate the performance of tissue doppler in predicting weaning outcome.


Recruitment information / eligibility

Status Recruiting
Enrollment 50
Est. completion date December 30, 2024
Est. primary completion date November 30, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Invasive mechanical ventilation for at least 48 hours Exclusion Criteria: - reintubation for extra respiratory failure (neurologic or hemodynamic) - Patients with chronic repiratory failure

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
diaphragm ultrasound monitoring
Ultrasound measure the diaphragm excursion, thickening fraction and maximal contraction and relaxation velocities

Locations

Country Name City State
Tunisia Mongi Slim hospital 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 weaning from mechanical ventilation success no need of non invasive ventilation or reintubation Day 2
See also
  Status Clinical Trial Phase
Completed NCT05539599 - Comprehensive Ultrasound Evaluation as a Predictor of Weaning
Completed NCT01779297 - New Integrated Weaning Indexes N/A
Completed NCT02883465 - Ultrasound Diagnostic for Diaphragmatic Dysfunction in Reanimation N/A