Measuring brain activity related to breathing difficulties in ICU patients
Analysis of the Relationship Between Dyspnea and Cerebral Cortex Activation Measured by Functional Near-Infrared Spectroscopy During a Spontaneous Breathing Trial
This study looks at how breathing difficulties affect ICU patients during a breathing trial to help better understand and measure their discomfort.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 22 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT06211738 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess dyspnea in ICU patients who are undergoing a spontaneous breathing trial (SBT). It utilizes established methods for measuring dyspnea, including the dyspnea visual analogue scale (D-VAS) and the Mechanical Ventilation Respiratory Distress Observational Scale (MV-RDOS). The study will not alter patient management but will collect data on dyspnea and related physiological responses during the SBT. The goal is to improve the detection and quantification of dyspnea in patients who may be unable to communicate their symptoms effectively.
Who should consider this trial
Good fit: Ideal candidates include ICU patients on invasive mechanical ventilation for more than 24 hours who are deemed ready for a spontaneous breathing trial.
Not a fit: Patients who are minors, pregnant, or under sedation/agitation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance the ability to detect and manage dyspnea in non-communicating ICU patients, leading to improved patient outcomes.
How similar studies have performed: Other studies have explored similar observational scales for dyspnea detection, indicating potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Invasive mechanical ventilation \> 24h * Ability to realize a spontaneous breathing trial, defined by the following criteria: Effective cough, no excessive tracheo-bronchial secretions, resolution of the disease that prompted the intubation, heart rate ≤ 140/min, pressure systolic blood pressure between 90 and 160 mmHg, no or very low dose of amines, SpO2 \> 90% in 40% FiO2 (or PaO2/FiO2 \> 150), positive expiratory pressure \< 8 cmH2O, respiratory rate ≤ 35/min, tidal volume \> 5ml/kg of theoretical body weight, respiratory rate / tidal volume ratio \< 105 cycles/min/L * Decision by the clinician in charge of the patient to perform a SBT, * Patient or relative consent obtained. Exclusion Criteria: * Minor patient, * Pregnant or breastfeeding woman * Agitation/sedation: RASS ( Richmond Agitation-Sedation Scale) \> 2 or \< 2, * Person under legal protection (guardianship, curators), safeguarded by justice.
Where this trial is running
Paris
- Service de Médecine Intensive Réanimation du département R3S, hôpital Pitié salpêtrière — Paris, France (Recruiting)
Study contacts
- Principal investigator: Maxens DECAVELE, MD — GHU APHP- Sorbonne Université
- Study coordinator: Maxens DECAVELE, MD
- Email: maxens.decavele@aphp.fr
- Phone: 07.71.27.58.10
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.