WeaningDIASTNCT06009731
Diaphragmatic Speckle Tracking During Spontaneous Breathing Trial
An observational study of Weaning and Spontaneous Breathing Trial, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Currently, measurement of transdiaphragmatic pressure (Pdi) using oesophageal and gastric balloons is the gold standard for the assessment of diaphragmatic effort. This technique is relatively invasive and its interpretation may be complex. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Weaning, Spontaneous Breathing Trial, Mechanical Ventilation
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 12 Jun 2023to Jul 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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
- Adult, Older adult
Study population: Consecutive adult patients (≥18 years old) undergoing mechanical ventilation for at least 24h (regardless of the reason of intubation) and fulfilling criteria for an SBT will be included in the study. Briefly, to be eligible for an SBT, patients will have to (i) be able to trigger ventilator breaths with a reasonable level of assistance, (ii) lack of severe impairment in gas exchange, and (iii) not require significant hemodynamic support. Patients will be recruited by the study coordinator following completion of informed consent from the patient or legally authorized substitute decision maker.
Who may be able to join
- Consecutive adult patients (≥18 years old) undergoing mechanical ventilation for at least 24h (regardless of the reason of intubation)
- patients fulfilling criteria for an SBT
- patients will have to be able to trigger ventilator breaths with a reasonable level of assistance,
- patients with lack of severe impairment in gas exchange,
- patients that not require significant hemodynamic support.
- Patients will be recruited by the study coordinator following completion of informed consent from the patient or legally authorized substitute decision maker.
Who cannot join
- Use of pressure support during the SBT.
- Severe hemodynamic instability (>30% increase in vasopressors in the last 6 hours or norepinephrine > 0.5 µg/kg/min).
- Severe or very severe chronic obstructive pulmonary disease (COPD) according to the GOLD criteria (stage III: FEV1 30-50% predicted; stage IV: FEV1 < 30% predicted).
- Known or suspected severe or progressive neuromuscular disorder likely to result in prolonged or chronic ventilator dependence
- Clinical judgement of the attending physician.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Amiens
Amiens, 80480
Clement Brault, MD
Yoann Zerbib, MD
About this study
Official title: DIAPHRAGMATIC SPECKLE TRACKING DURING SPONTANEOUS BREATHING TRIAL
Currently, measurement of transdiaphragmatic pressure (Pdi) using oesophageal and gastric balloons is the gold standard for the assessment of diaphragmatic effort. This technique is relatively invasive and its interpretation may be complex. The diaphragmatic longitudinal strain (LSdi) and strain rate (LSRdi) might provide additional information in the assessment of diaphragmatic effort and movement during SBT, allowing early detection of diaphragmatic dysfunction. Patients will be monitored during a 30-120 minutes SBT consisting of no assistance on the ventilator using CPAP with a pressure level of 0 cmH2O. Parameters to evaluate diaphragm function will include diaphragmatic strain (LSdi and LSRdi), diaphragmatic thickening fraction (TFdi), and airway occlusion pressure (ΔP0.1 and ΔPocc). These parameters will be measured immediately before ('baseline') the SBT, as well as 2 minutes ('early' assessment), 15 ('intermediate' assessment) and 30 minutes ('late' assessment) after the beginning of the SBT.
- Conditions
- Weaning, Spontaneous Breathing Trial, Mechanical Ventilation, Speckle Tracking, Strains, Diaphragm
- Keywords
- weaning, spontaneous breathing trial, mechanical ventilation, speckle tracking, Strains, diaphragm
- Medical subject headings
- Sprains and Strains
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| adult patients undergoing mechanical ventilation | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes of diaphragmatic longitudinal strain between baseline and during Spontaneous breathing trial
diaphragmatic longitudinal strain is LSdi Spontaneous breathing trial is SBT
Measured: 7 days
changes of diaphragmatic longitudinal strain strain rate between baseline and during Spontaneous breathing trial
diaphragmatic longitudinal strain strain rate is LSRdi Spontaneous breathing trial is SBT
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2023
- Study start12 Jun 2023
- Primary completionJun 2027 (estimated)
- Study completionJul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for WeaningStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06009731
- Sponsor's protocol ID
- PI2023_843_0040
- Acronym
- DIAST
- Status last verified
- May 2026
- First submitted
- 18 Jul 2023
- Last updated
- 15 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DIAPHRAGMATIC SPECKLE TRACKING DURING SPONTANEOUS BREATHING TRIAL
- ClinicalTrials.gov ID
- NCT06009731
- Acronym / sponsor ID
- DIAST / PI2023_843_0040
- Conditions
- Weaning, Spontaneous Breathing Trial, Mechanical Ventilation, Speckle Tracking, Strains, Diaphragm
- Keywords
- weaning, spontaneous breathing trial, mechanical ventilation, speckle tracking, Strains, diaphragm
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 12 Jun 2023 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jul 2027 (estimated)
- First posted
- 24 Aug 2023 (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.
Currently, measurement of transdiaphragmatic pressure (Pdi) using oesophageal and gastric balloons is the gold standard for the assessment of diaphragmatic effort. This technique is relatively invasive and its interpretation may be complex. The diaphragmatic longitudinal strain (LSdi) and strain rate (LSRdi) might provide additional information in the assessment of diaphragmatic effort and movement during SBT, allowing early detection of diaphragmatic dysfunction. Patients will be monitored during a 30-120 minutes SBT consisting of no assistance on the ventilator using CPAP with a pressure level of 0 cmH2O. Parameters to evaluate diaphragm function will include diaphragmatic strain (LSdi and LSRdi), diaphragmatic thickening fraction (TFdi), and airway occlusion pressure (ΔP0.1 and ΔPocc). These parameters will be measured immediately before ('baseline') the SBT, as well as 2 minutes ('early' assessment), 15 ('intermediate' assessment) and 30 minutes ('late' assessment) after the beginning of the SBT.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adult patients undergoing mechanical ventilation | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Consecutive adult patients (≥18 years old) undergoing mechanical ventilation for at least 24h (regardless of the reason of intubation) and fulfilling criteria for an SBT will be included in the study. Briefly, to be eligible for an SBT, patients will have to (i) be able to trigger ventilator breaths with a reasonable level of assistance, (ii) lack of severe impairment in gas exchange, and (iii) not require significant hemodynamic support. Patients will be recruited by the study coordinator following completion of informed consent from the patient or legally authorized substitute decision maker.
Key inclusion criteria (6 listed)
- Consecutive adult patients (≥18 years old) undergoing mechanical ventilation for at least 24h (regardless of the reason of intubation)
- patients fulfilling criteria for an SBT
- patients will have to be able to trigger ventilator breaths with a reasonable level of assistance,
- patients with lack of severe impairment in gas exchange,
- patients that not require significant hemodynamic support.
Key exclusion criteria (5 listed)
- Use of pressure support during the SBT.
- Severe hemodynamic instability (>30% increase in vasopressors in the last 6 hours or norepinephrine > 0.5 µg/kg/min).
- Severe or very severe chronic obstructive pulmonary disease (COPD) according to the GOLD criteria (stage III: FEV1 30-50% predicted; stage IV: FEV1 < 30% predicted).
- Known or suspected severe or progressive neuromuscular disorder likely to result in prolonged or chronic ventilator dependence
- Clinical judgement of the attending physician.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
changes of diaphragmatic longitudinal strain between baseline and during Spontaneous breathing trial
Time frame: 7 days
diaphragmatic longitudinal strain is LSdi Spontaneous breathing trial is SBT
changes of diaphragmatic longitudinal strain strain rate between baseline and during Spontaneous breathing trial
Time frame: 7 days
diaphragmatic longitudinal strain strain rate is LSRdi Spontaneous breathing trial is SBT
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 May 2026.
- Individual participant dataSharing planned: No
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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.
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 Weaning and Spontaneous Breathing Trial, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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 6 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 15 May 2026. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clément Brault, MD (03 22 08 89 09, brault.clement@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes of diaphragmatic longitudinal strain between baseline and during Spontaneous breathing trial (time frame: 7 days). The study lists 2 primary outcomes in all. 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 15 May 2026.