Monitoring diaphragm function during breathing trials
DIAPHRAGMATIC SPECKLE TRACKING DURING SPONTANEOUS BREATHING TRIAL
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 |
|---|---|
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Centre Hospitalier Universitaire, Amiens Academic / other |
| Locations | 1 site (Amiens) |
| Trial ID | NCT06009731 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
Not a fit: Patients with severe hemodynamic instability or severe chronic obstructive pulmonary disease may not benefit from this study.
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 performed: While the use of speckle tracking for diaphragm assessment is relatively novel, similar approaches in monitoring respiratory function have shown promise in other studies.
Eligibility criteria
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 this trial is running
Amiens
- CHU Amiens — Amiens, France (Recruiting)
Study contacts
- Study coordinator: Clément Brault, MD
- Email: brault.clement@chu-amiens.fr
- Phone: 03 22 08 89 09
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.