Monitoring diaphragm function during breathing trials
Official title: DIAPHRAGMATIC SPECKLE TRACKING DURING SPONTANEOUS BREATHING TRIAL
Run by Centre Hospitalier Universitaire, Amiens · NCT06009731 · Data updated 2026-11-12
This study is testing a new way to monitor how well the diaphragm works in patients trying to breathe on their own without a ventilator.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Centre Hospitalier Universitaire, Amiens Academic / other |
| Locations | 1 site (Amiens) |
| Status | Recruiting |
| Started | June 12, 2023 |
| Main results expected | June 2027 |
| Study ends | July 2027 |
| Registry record updated | May 15, 2026 |
| Trial ID | NCT06009731 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include adult patients who have been mechanically ventilated for at least 24 hours and meet the criteria for a spontaneous breathing trial.
✕Probably not a fit
Patients with severe hemodynamic instability or severe chronic obstructive pulmonary disease may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This observational study aims to assess diaphragmatic effort in patients undergoing spontaneous breathing trials (SBT) using non-invasive speckle tracking technology. By measuring parameters such as diaphragmatic longitudinal strain and strain rate, the study seeks to provide a clearer understanding of diaphragm function during mechanical ventilation weaning. Patients will be monitored during a 30-120 minute SBT without ventilator assistance, allowing for the evaluation of diaphragm performance at various time points. This approach may offer a less invasive alternative to traditional methods of measuring diaphragmatic pressure.
Why it matters
Potential benefit: If successful, this study could lead to improved methods for assessing diaphragm function, potentially enhancing patient outcomes during weaning from mechanical ventilation.
How similar studies have gone: While the use of speckle tracking for diaphragm assessment is relatively novel, similar approaches in monitoring respiratory function have shown promise in other studies.
Who can join: the full rules
Show full inclusion / exclusion criteria
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 informed consent from the patient or legally authorized substitute decision maker. 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 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.
Where it's running
-
CHU Amiens
Amiens, France Recruiting
Study contacts
- Study coordinator: Clément Brault, MD
- Email: brault.clement@chu-amiens.fr
- Phone: 03 22 08 89 09
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.