Breathlessness during ventilator weaning in obese ICU patients
Prevalence, Determinants and Consequences of Dyspnea During Weaning in Critically Ill Obese Patients
This project will measure how often and how severe breathlessness is when obese ICU patients try to breathe on their own during ventilator weaning.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 80 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris, Paris) |
| Trial ID | NCT06867354 on ClinicalTrials.gov |
What this trial studies
This is an observational study of obese patients in the ICU who have been mechanically ventilated and are undergoing a spontaneous breathing trial (SBT). Investigators will use patient-reported Dyspnea-VAS and the Respiratory Distress Observation Scale (MV-RDOS) to document breathlessness during weaning. The study will record physiological factors, ventilator settings, and weaning outcomes including success or need for reintubation to identify determinants and consequences of dyspnea. All data are collected at the medical intensive care unit of Hôpital Tenon (AP-HP) in Paris.
Who should consider this trial
Good fit: Adults with obesity who have been mechanically ventilated for at least 48 hours and are undergoing a spontaneous breathing trial in the ICU while meeting oxygenation and stability criteria are the intended participants.
Not a fit: Patients who are not obese, not mechanically ventilated, too unstable for a spontaneous breathing trial, or who decline participation are unlikely to benefit from this project.
Why it matters
Potential benefit: If successful, the results could help clinicians better recognize and manage breathlessness during weaning in obese ICU patients, potentially reducing failed extubations and psychological distress.
How similar studies have performed: Previous ICU research has shown dyspnea is common and measurable with tools like Dyspnea-VAS and MV-RDOS, but focused data on obese patients during weaning are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients placed on mechanical ventilation for at least 48 hours * On spontaneous ventilation mode with inspiratory support (only possible ventilation mode during ventilation weaning) allowing a tidal volume \> 6 mL/kg and a positive end-expiratory pressure set by the attending physician between 5 and 8 cmH2O * Decision by the attending physician to perform a spontaneous breathing trial (SBT) after verifying the prerequisites for weaning: resolution of the acute phase of the illness for which the patient is placed on invasive mechanical ventilation, low bronchial congestion, adequate cough, adequate oxygenation defined by SpO2 \> 90% with FiO2 ≤ 40% and PEEP ≤ 8 cmH2O, respiratory rate ≤ 40 breaths/min, Ramsay sedation score \< 4, and stable cardiovascular state (heart rate ≤ 120 beats/min, systolic blood pressure ≤ 180 mmHg, and no or minimal vasopressors \[norepinephrine \< 5 μg/kg/min\]) * After information,no opposition from the patient or the relative (if the patient is unable to express his non opposition) to participating in the research * Person affiliated with a social security regime or eligible * Patient with a BMI \> 30 kg/m² for those included in the case group (obesity) Exclusion Criteria: * Under 18 years old * Pregnant or breastfeeding women * Patients for whom weaning is impossible (pre-existing neuromuscular disorders, cervical spinal cord lesions) * Patients for whom repeated dyspnea assessment is likely to be difficult (known history of cognitive or psychiatric disorders, delirium, Richmond Agitation-Sedation Scale score less than -2 or greater than 2) * Patients under legal protection measures (guardianship, curatorship)
Where this trial is running
Paris, Paris
- Service de Médecine Intensive-Réanimation Hôpital Tenon, AP-HP — Paris, Paris, France (Recruiting)
Study contacts
- Study coordinator: Alexandra BEURTON, Doctor
- Email: alexandra.beurton@aphp.fr
- Phone: 00 33 6 23 08 64 88
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.