ClinicalTrials.gg
RecruitingNCT06009731DIASTUpdated May 15, 2026

Diaphragmatic Speckle Tracking During Spontaneous Breathing Trial

An observational study in Weaning, Spontaneous Breathing Trial and Mechanical Ventilation, sponsored by Centre Hospitalier Universitaire, Amiens. Recruiting at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-15.

Sponsored by Centre Hospitalier Universitaire, Amiens · Observational

From the registry’s dates

  • Started Jun 2023; still recruiting 3 years 5 months later.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
60
Ages
18 Years and older
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 29 studies in Sprains and Strains with a site in France — 7 open to participants now, 8 under way, none of them phase 3. Sprains and Strains · France.

Planned enrollment
12th of 16
60 · median 101
Started
2023
with 1 other
Observational
16 of 29
5 open now
Registered
23rd of 29
by date
Lead sponsor
4 of 29
Centre Hospitalier Universitaire, Amiens

Among the 29 studies in Sprains and Strains with a site in France, this one is the 12th largest by planned enrollment of the 16 observational ones that give a count, is one of 2 that started in 2023, is one of 16 observational ones, and was the 23rd registered.

Sprains and Strains

246 studies on the registry are indexed under Sprains and Strains; 49 are open to participants now.

Browse Sprains and Strains studies →

Open to participants now

7 of the 29 studies in Sprains and Strains with a site in France are open now. Recruiting first, the newest first:

1 more — sign in →

All 7 open studies →

A study can be open while its sites in France have not opened yet or have stopped. Only those recruiting at a site in France →

Who these studies take

Of the 36 Sprains and Strains studies recruiting now, 13 (36%) set no upper age limit and 20 (56%) stop at 75 or younger; 7 take children under 18; 9 take healthy volunteers.

This study: 18 Years and older · all sexes.

The full table on the hub →

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 29 studies in Sprains and Strains with a site in France, or all of them as a file.
02

Study 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. 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.

03

Conditions studied

  • Weaning
  • Spontaneous Breathing Trial
  • Mechanical Ventilation
  • Speckle Tracking
  • Strains
  • Diaphragm

Browse trials for

Keywords

  • weaning
  • spontaneous breathing trial
  • mechanical ventilation
  • speckle tracking
  • Strains
  • diaphragm
04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

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.

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

  • 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 from the patient or legally authorized substitute decision maker.

Exclusion criteria

Exclusion Criteria:

  • 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 (COPD) according to the GOLD criteria (stage III: 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.
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

COPD

Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.

FEV1

From a breathing test (spirometry): how much air you can blow out in the first second. Often given as a percentage of what is expected for your age, height and sex.

05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
60 participants (estimated)
Patient registry
No

Groups and cohorts

  • adult patients undergoing mechanical ventilation
06

What researchers measure

Primary outcomes

  1. changes of diaphragmatic longitudinal strain between baseline and during Spontaneous breathing trial

    diaphragmatic longitudinal strain is LSdi Spontaneous breathing trial is SBT

    Time frame: 7 days

  2. 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

    Time frame: 7 days

07

Study locations

1 of 1 sites recruiting
  • CHU Amiens
    Amiens, 80480, France
    Recruiting
    • Clement Brault, MD · Contact
    • Yoann Zerbib, MD · Sub investigator
    • Julien Maizel, Pr · Sub investigator
    • Michel Slama, Pr · Sub investigator
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Jun 2023 (actual). Primary completion is estimated for Jun 2027, 48 months after the start.

Of 36 observational studies under Sprains and Strains, half reached primary completion within 25 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 36. This study's planned 48 months is above that.

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

Registered
Jul 18, 2023
First posted
Aug 24, 2023
StartActual
Jun 12, 2023
Primary completionEst.
Jun 2027
CompletionEst.
Jul 2027
Last update
May 15, 2026
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 May 15, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06009731
Responsible party
Sponsor
First posted
Aug 24, 2023
Start date
Jun 12, 2023
Primary completion
Jun 2027 (estimated)
Completion
Jul 2027 (estimated)
Last update
May 15, 2026

Study contacts

Clément Brault, MD
Contact
brault.clement@chu-amiens.fr
03 22 08 89 09

Oversight

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

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