Mechanical Ventilation WeaningNCT06203353
Evaluation of the Diaphragm Performance During Weaning From Mechanical Ventilation
An observational study of Mechanical Ventilation Weaning, run by Mongi Slim Hospital at 1 site in Tunisia.
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mechanical Ventilation Weaning
- What is being tested?
- diaphragm ultrasound monitoring
- How many people
- 50 participants
- Where
- 1 siteTunisia
- Study dates
- 1 Nov 2023to 30 Dec 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- Invasive mechanical ventilation for at least 48 hours
Who cannot join
- reintubation for extra respiratory failure (neurologic or hemodynamic)
- Patients with chronic repiratory failure
Trial locations and contacts
1 site in 1 country.
Tunisia1 site, 1 recruiting
- Recruiting
Mongi Slim hospital
Tunis, 2085
Mhamed sami Mebazaa, Pr, 22252589 ext. 00216, msmebazaa@gmail.com
Asma Ben Souissi, Asso Pr, 98336883 ext. 00216, bsouissiasma@gmail.com
About this study
Official title: Evaluation of the Diaphragm Tissue Doppler Parameters in Predicting Weaning From Mechanical Ventilation Outcome
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.
- Conditions
- Mechanical Ventilation Weaning
- Being tested
- diaphragm ultrasound monitoring
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diaphragm ultrasound monitoringDiagnostic test
Ultrasound measure the diaphragm excursion, thickening fraction and maximal contraction and relaxation velocities
| Study group | Role | What they receive |
|---|---|---|
| weaning success | Patients extubated with no need to non invasive ventilatry support during 48 hours Receives: Diagnostic Test: diaphragm ultrasound monitoring | |
| weaning failure | patients requiring reintubation or non invasive ventilation within 48 hours after extubation Receives: Diagnostic Test: diaphragm ultrasound monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
weaning from mechanical ventilation success
no need of non invasive ventilation or reintubation
Measured: Day 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2024
- Study start1 Nov 2023
- Primary completion30 Nov 2024 (estimated)
- Study completion30 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mechanical Ventilation WeaningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mongi Slim Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mhamed Sami Mebazaa, Mongi Slim Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06203353
- Sponsor's protocol ID
- Diaphram Tissue Doppler
- Status last verified
- Dec 2023
- First submitted
- 28 Dec 2023
- Last updated
- 12 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Diaphragm Tissue Doppler Parameters in Predicting Weaning From Mechanical Ventilation Outcome
- ClinicalTrials.gov ID
- NCT06203353
- Acronym / sponsor ID
- Diaphram Tissue Doppler
- Conditions
- Mechanical Ventilation Weaning
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Mongi Slim HospitalUniversity, hospital or other
- Study start
- 1 Nov 2023 (actual)
- Primary completion
- 30 Nov 2024 (estimated)
- Study completion
- 30 Dec 2024 (estimated)
- First posted
- 12 Jan 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| weaning success | – | Diagnostic Test: diaphragm ultrasound monitoringPatients extubated with no need to non invasive ventilatry support during 48 hours |
| weaning failure | – | Diagnostic Test: diaphragm ultrasound monitoringpatients requiring reintubation or non invasive ventilation within 48 hours after extubation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- Invasive mechanical ventilation for at least 48 hours
Key exclusion criteria (2 listed)
- reintubation for extra respiratory failure (neurologic or hemodynamic)
- Patients with chronic repiratory failure
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| diaphragm ultrasound monitoringUltrasound measure the diaphragm excursion, thickening fraction and maximal contraction and relaxation velocities | Diagnostic test | weaning failure, weaning success |
Primary outcome
weaning from mechanical ventilation success
Time frame: Day 2
no need of non invasive ventilation or reintubation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2024.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mechanical Ventilation Weaning, run by Mongi Slim Hospital at 1 site in Tunisia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 12 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Tunisia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mhamed Mebazaa, professor (22252589 ext. 00216, msmebazaa@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
weaning from mechanical ventilation success (time frame: Day 2). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jan 2024.