Prevalence, Determinants and Consequences of Dyspnea During Weaning in Critically Ill Obese Patients
Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Mar 7, 2025
Trial Information
Current as of June 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying how common breathlessness, or dyspnea, is in critically ill obese patients who are trying to stop using a ventilator. Dyspnea can be very distressing and has been overlooked in many cases, even though it greatly affects patients' well-being. The trial aims to understand the differences between obese patients and those who are not obese regarding their experience of dyspnea and the challenges they face while trying to breathe on their own after being on a ventilator. This understanding is important, as it can help improve care for these patients and reduce complications during recovery.
To be eligible for this trial, participants must be adults who have been on a ventilator for at least 48 hours and have a body mass index (BMI) over 30, which indicates obesity. They need to be in a stable condition, showing signs that they might be ready to breathe on their own, such as adequate oxygen levels and a stable heart rate. Patients will be monitored for their experience of breathlessness and will undergo tests to see how well they can breathe independently. This research is not yet recruiting participants, but it aims to shed light on a significant aspect of care for critically ill obese patients.
Gender
ALL
Eligibility 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)
About Assistance Publique Hôpitaux De Paris
Assistance Publique - Hôpitaux de Paris (AP-HP) is a leading public hospital system in France, renowned for its commitment to healthcare excellence and innovative medical research. As a prominent clinical trial sponsor, AP-HP plays a pivotal role in advancing medical knowledge and improving patient care through rigorous scientific investigations across a wide range of therapeutic areas. With a focus on collaboration and interdisciplinary approaches, AP-HP leverages its extensive network of hospitals and expert clinicians to facilitate high-quality clinical trials that adhere to the highest ethical and regulatory standards, ultimately aiming to translate research findings into tangible health benefits for diverse patient populations.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Paris, , France
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported