RecruitingCOPD ExacerbationOxygen ToxicityAbdominal Obesity
Influence of FreeO2 on Percentage of Time Within Oxygen Saturation Target Using Noninvasive Ventilation (NIV) and Continuous Positive Airway Pressure (CPAP) for Patients Admitted for AECOPD or Bariatric Surgery
Eligible age
18+ yrs
Accepts
All genders
Locations
0 states
Healthy volunteers
No
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About this study
The main objective is to evaluate the FreeO2 device combined with noninvasive respiratory support technique for COPD patients and postoperative bariatric surgery patients. The main hypothesis is that FreeO2 device for oxygen therapy associated with NIV or nasal high flow oxygen therapy (NHFOT) allows to reach better oxygenation and avoid hypoxemia and hyperoxia.
Sponsor: François Lellouche
You may qualify if…
- ✓ Respiratory acidosis (pH \<= 7.35 and PaCO2 \> 45 mmHg), with or without NIV (last blood gas available during hospitalization)
- ✓ Oxygen therapy and/or SpO2 \<90% room air (FiO2 \<= 50% or nasal cannula \<= 7 L/min to maintain SpO2 90%)
- ✓ High flow nasal cannula with flow \<= 30 L/min
- ✓ Patients using CPAP before the surgery (obstructive sleep apnea documented).
- ✓ Patients with obesity hypoventilation syndrome in addition to obstructive sleep apnea can be included.
You may not qualify if…
- ✕ Age \< 18
- ✕ Pregnancy
- ✕ Respiratory distress or other clinical situation requiring continuous NIV or CPAP
- ✕ Glasgow \< 12 or agitation/delirium/dementia (limiting NIV)
- ✕ Any contraindication to NIV (state requiring immediate endotracheal intubation, pneumothorax, recent esophagus surgery)
- ✕ Hemodynamic instability (at the beginning of the study) (increasing doses of vasopressors or inotropes)
- ✕ Refusal to consent to the study
- ✕ 5 patient with AECOPD and 5 patient with bariatric surgery will be included.
Source: ClinicalTrials.gov · NCT04136717 · last updated 2025-09-04