ClinicalTrials.gg
RecruitingNCT06203353Updated Jan 12, 2024

Evaluation of the Diaphragm Performance During Weaning From Mechanical Ventilation

An observational study in Mechanical Ventilation Weaning, sponsored by Mongi Slim Hospital. Recruiting at 1 site in Tunisia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-01-12.

Sponsored by Mongi Slim Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Nov 2024, 1 year 11 months ago, but the record still lists the study as recruiting.
  • Started Nov 2023; still recruiting 3 years later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
50
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed 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.

02

Conditions studied

  • Mechanical Ventilation Weaning
03

In context

Lead sponsor

Mongi Slim Hospital is the lead sponsor of 38 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Invasive mechanical ventilation for at least 48 hours

Exclusion criteria

Exclusion Criteria:

  • reintubation for extra respiratory failure (neurologic or hemodynamic)
  • Patients with chronic repiratory failure
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
50 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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

  • Diagnostic testdiaphragm ultrasound monitoring

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

06

What researchers measure

Primary outcomes

  1. weaning from mechanical ventilation success

    no need of non invasive ventilation or reintubation

    Time frame: Day 2

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Nov 2023 (actual). Primary completion is estimated for Nov 2024, 12 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 28, 2023
First posted
Jan 12, 2024
StartActual
Nov 1, 2023
Primary completionEst.
Nov 30, 2024
CompletionEst.
Dec 30, 2024
Last update
Jan 12, 2024
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jan 12, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06203353
Lead sponsor
Mongi Slim Hospital
Responsible party
Mhamed Sami Mebazaa (Professor head of anesthesiology and ICU department, Mongi Slim Hospital) — Principal investigator
First posted
Jan 12, 2024
Start date
Nov 1, 2023
Primary completion
Nov 30, 2024 (estimated)
Completion
Dec 30, 2024 (estimated)
Last update
Jan 12, 2024

Study contacts

Mhamed Mebazaa, professor
Contact
msmebazaa@gmail.com
22252589 ext. 00216
Asma Ben Souissi, Asso Prof
Contact
bsouissiasma@gmail.com
98336883 ext. 00216

Oversight

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

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion