Studies Breathlessness During Weaning in Critically Ill Obese Patients
Observes breathlessness and ventilator weaning difficulty in critically ill adults with obesity.
Key facts
- Who runs it
- Assistance Publique - Hôpitaux de Paris
- Where
- Paris, FranceSee the site
- Trial code
- Registry title
- Prevalence, Determinants and Consequences of Dyspnea During Weaning in Critically Ill Obese Patients
- Status
- Recruiting
- People taking part
- 80 people, planned
- Started
- 21 Mar 2025
- Expected to end
- May 2027
- Type of study
- Observational, 2 groups
- Record updated
- 5 June 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults in intensive care who have been on a ventilator for at least 48 hours and are about to start a breathing test before ventilator weaning. It compares obese and non-obese patients.
- Age
- 18 years or older
- Sex
- All sexes can join
- Disease stage
- Patients in intensive care on a ventilator for at least 48 hours, when the doctor decides to do a spontaneous breathing trial, with the acute illness resolved and stable breathing and circulation. Obese group: BMI above 30 kg/m².
- Earlier treatment
- On a ventilator for at least 48 hours, using a mode that supports each breath.
Main reasons for not taking part
- Under 18 years old
- Pregnant or breastfeeding women
- Weaning is impossible (for example, existing nerve and muscle disease or neck spinal cord injury)
- Repeated dyspnea checks likely to be difficult (for example, cognitive or psychiatric disorders, delirium, or very agitated or very sedated)
- Under legal protection measures (guardianship, curatorship)
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- 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)
Who cannot take part
- 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)
- Under 18 years old
- Pregnant or breastfeeding women
- Patients under legal protection measures (guardianship, curatorship)
Where in France
- Service de Médecine Intensive-Réanimation Hôpital Tenon, AP-HPParis, FranceContact: Muriel FARTOUKH, ProfessorTaking people
About the trial
What the trial wants to find out
ICU patients encounter numerous discomforts, with dyspnea (the sensation of breathlessness) being among the most distressing and impactful. Unlike pain, dyspnea in ICU settings has historically received limited attention, despite its severe psychological impact. ICU clinicians often use assessment tools like the simple numerical dyspnea scale (Dyspnea-VAS) and the Respiratory Distress Observation Scale (MV-RDOS) to measure dyspnea. These scales are also utilized during the weaning process, an essential phase when patients attempt to breathe independently without ventilator assistance. Weaning is crucial for ICU patients, as delayed or unsuccessful extubation increases the risk of complications and mortality.
Read full original descriptionShow less
Obese ICU patients, often admitted due to respiratory failure, present unique challenges due to physiological changes in the respiratory system, such as reduced functional residual capacity and decreased lung compliance. These factors contribute to an increased likelihood of dyspnea and weaning complications. Approximately 50% of obese ICU patients require mechanical ventilation, and once ventilated, obese patients exhibit an elevated risk for dyspnea and ventilator weaning failure.
Understanding the prevalence, causes, and consequences of dyspnea and failure in weaning process in obese ICU patients is critical. In this study, the aim is to compare obese patients with non-obese patients in terms of dyspnea prevalence, causes and consequences as weaning failure prevalence, causes and consequences.
The 2 groups in the trial
- Patients with (BMI of ≥30 kg/m²) obesity
- Patients without obesity
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Prevalence, Determinants and Consequences of Dyspnea During Weaning in Critically Ill Obese Patients
- Plain-language title
- Studies Breathlessness During Weaning in Critically Ill Obese PatientsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 5 June 2025