Breathlessness during ventilator weaning in obese ICU patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Pulmonary and cardiovascular rehabilitation program for chronic respiratory and heart conditions

  This study tests a rehabilitation program that combines exercise for people with chronic lung and heart conditions to see if it helps them feel better and improve their daily activities.

  Recruiting University of Campinas, Brazil · Campinas, São Paulo · NCT06772922

• Assessing diaphragm function in patients with respiratory diseases

  This study is testing how well the diaphragm works in people with respiratory diseases to see if it affects their breathing difficulties and overall health.

  Recruiting RWTH Aachen University · Aachen, North Rhine-Westphalia · NCT05903001

• Ocular Changes in People Using Tirzepatide or Semaglutide

  This study checks whether eye structure and blood vessels change in adults with obesity who are taking semaglutide or tirzepatide as part of routine care.

  Recruiting Istanbul University · Istanbul, Istanbul · NCT07924618

• Whole-Body Vibration Training in Women With Obesity With and Without Type 2 Diabetes

  This study tests whether eight weeks of supervised whole-body vibration training changes ankle muscle activity and walking performance in women with obesity, comparing those with and without type 2 diabetes.

  Recruiting Pamukkale University · Denizli · NCT07924436

• Berobenatide for knee pain in adults who are overweight or with obesity

  This study tests berobenatide vs. placebo to see if it reduces knee pain and improves function while helping with weight in adults with knee osteoarthritis and overweight/obesity.

  Recruiting at 7 sites Phase 3 Pfizer · Tempe, Arizona and 39 other locations · NCT07919678

• Weekly berobenatide for knee osteoarthritis in adults who are overweight or obese

  This study tests whether weekly berobenatide helps reduce knee pain and improve function, while also affecting body weight, in adults with knee osteoarthritis who are overweight or obese (with or without type 2 diabetes).

  Recruiting Phase 3 Pfizer · Birmingham, Alabama and 3 other locations · NCT07915609

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.