NCT06203353

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 28, 2023

Completed
15 days until next milestone

First Posted

Study publicly available on registry

January 12, 2024

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2024

Completed
Last Updated

January 12, 2024

Status Verified

December 1, 2023

Enrollment Period

1.1 years

First QC Date

December 28, 2023

Last Update Submit

January 11, 2024

Conditions

Mechanical Ventilation Weaning

Outcome Measures

Primary Outcomes (1)

  • weaning from mechanical ventilation success

    no need of non invasive ventilation or reintubation

    Day 2

Study Arms (2)

weaning success

Patients extubated with no need to non invasive ventilatry support during 48 hours

Diagnostic Test: diaphragm ultrasound monitoring

weaning failure

patients requiring reintubation or non invasive ventilation within 48 hours after extubation

Diagnostic Test: diaphragm ultrasound monitoring

Interventions

diaphragm ultrasound monitoringDIAGNOSTIC_TEST

Ultrasound measure the diaphragm excursion, thickening fraction and maximal contraction and relaxation velocities

weaning failureweaning success

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients undergoing weaning from mechanical ventilation: Pressure support ventilation with the lowest level of support Glasgow coma scale of at least 13 Hemodynamic stability with no vasopressors

You may qualify if:

  • Invasive mechanical ventilation for at least 48 hours

You may not qualify if:

  • reintubation for extra respiratory failure (neurologic or hemodynamic)
  • Patients with chronic repiratory failure

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mongi Slim hospital

Tunis, 2085, Tunisia

RECRUITING

Central Study Contacts

Mhamed Mebazaa, professor

CONTACT

22252589msmebazaa@gmail.com

Asma Ben Souissi, Asso Prof

CONTACT

98336883bsouissiasma@gmail.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor head of anesthesiology and ICU department

Study Record Dates

First Submitted

December 28, 2023

First Posted

January 12, 2024

Study Start

November 1, 2023

Primary Completion

November 30, 2024

Study Completion

December 30, 2024

Last Updated

January 12, 2024

Record last verified: 2023-12

Locations

TU(1)