Evaluation of the Diaphragm Performance During Weaning From Mechanical Ventilation

Mechanical Ventilation Weaning Clinical Trial

Official title:

Evaluation of the Diaphragm Tissue Doppler Parameters in Predicting Weaning From Mechanical Ventilation Outcome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06203353
• Other study ID #: Diaphram Tissue Doppler
• Status: Recruiting
• 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
• 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

Related Conditions & MeSH terms

• Mechanical Ventilation Weaning

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