Actively Recruiting
Prevalence, Determinants and Consequences of Dyspnea During Weaning in Critically Ill Obese Patients
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2025-06-05
80
Participants Needed
1
Research Sites
110 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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. 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.
CONDITIONS
Official Title
Prevalence, Determinants and Consequences of Dyspnea During Weaning in Critically Ill Obese Patients
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients placed on mechanical ventilation for at least 48 hours
- On spontaneous ventilation mode with inspiratory support allowing a tidal volume greater than 6 mL/kg
- Positive end-expiratory pressure set between 5 and 8 cmH2O
- Decision by the attending physician to perform a spontaneous breathing trial after meeting weaning prerequisites
- Resolution of the acute illness phase, low bronchial congestion, adequate cough, and adequate oxygenation (SpO2 > 90% with FiO2 ≤ 40% and PEEP ≤ 8 cmH2O)
- Respiratory rate ≤ 40 breaths/min
- Ramsay sedation score less than 4
- Stable cardiovascular state (heart rate ≤ 120 beats/min, systolic blood pressure ≤ 180 mmHg, no or minimal vasopressors)
- No opposition from patient or relative after information
- Person affiliated with a social security regime or eligible
- BMI greater than 30 kg/m² for obese group
You will not qualify if you...
- Under 18 years old
- Pregnant or breastfeeding women
- Patients for whom weaning is impossible (pre-existing neuromuscular disorders, cervical spinal cord lesions)
- Patients with cognitive or psychiatric disorders, delirium, or Richmond Agitation-Sedation Scale score less than -2 or greater than 2
- Patients under legal protection measures (guardianship, curatorship)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Service de Médecine Intensive-Réanimation Hôpital Tenon, AP-HP
Paris, Paris, France, 75020
Actively Recruiting
Research Team
A
Alexandra BEURTON, Doctor
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here