An interventional study of Washout period and NIV - FreeO2 in COPD Exacerbation, Oxygen Toxicity and Abdominal Obesity, sponsored by François Lellouche. Recruiting at 1 site in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-04.
Sponsored by François Lellouche · Not applicable, Interventional, and Treatment
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.
Bariatric surgery patients:
The main objective of this study is to evaluate the time spent in the SpO2 target (+/- 2% SpO2 target) and partial pressure of carbon dioxide (PCO2) values on patients with morbid obesity after bariatric surgery.
COPD patients:
The main objective of this study is to evaluate the time spent in the SpO2 target (+/- 2% SpO2 target) and PCO2 values on patients with exacerbation of COPD (hypercapnic patients) with different ventilatory supports (NIV and NHFOT) associated with FreeO2.
274 studies on the registry are indexed under Obesity, Abdominal; 44 are open to participants now.
This study's planned enrollment of 10 is below the median of 60 across 216 interventional studies indexed under Obesity, Abdominal.
Browse Obesity, Abdominal studies →François Lellouche is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria (AECOPD):
Inclusion Criteria (Bariatric surgery post-op):
Exclusion Criteria:
Refusal to consent to the study
5 patient with AECOPD and 5 patient with bariatric surgery will be included.
Patients with acute exacerbation of COPD and respiratory acidosis under oxygen therapy.
Other: Washout period · Device: NIV - FreeO2 · Device: Nasal High flow Oxygen therapy - FreeO2
Obese patients after gastric surgery under CPAP.
Other: CPAP - Oxygen constant flow · Other: CPAP - FreeO2
During this period the patients will breath spontaneously oxygen titrated using the FreeO2 device with a SpO2 target set at 90%. The period duration is 30 minutes.
During this period the patients will receive NIV using FreeO2 device for oxygen titration with a SpO2 target set at 90%. Initially, the inspiratory pressure will be set to obtain a tidal volume between 6 to 8 mL/Kg of predictive body weight and positive end-expiratory end pressure (PEEP) at 5 centimeters of water (cmH2O). After NIV initiation, the parameters can be adjusted to improve patient comfort. The period duration is 30 minutes.
During this period the patients will receive NHFOT using the FreeO2 device for oxygen titration with a SpO2 target set at 90%. The high flow device will be set at 30 lpm.The period duration is 30 minutes.
During this period, the patients will have their own CPAP with oxygen adjusted by hospital staff according to hospital protocol. The period duration is 15 minutes.
During this period, the patients will have their own CPAP with oxygen adjusted using the FreeO2 device. SpO2 target will be set at 90% The period duration is 60 minutes.
Percentage of time within SpO2 target
(SpO2 90 +/- 2%)
Time frame: AECOPD Patients: Day 1; Up to 120 minutes after start study procedures. Bariatric surgery patients: Day 1; up to 75 minutes after start study procedures(post-op).
Percentage of time in hypoxemia
(SpO2 \< -2% of SpO2 target)
Time frame: AECOPD Patients: Day 1; Up to 120 minutes after start study procedures. Bariatric surgery patients: Day 1; up to 75 minutes after start study procedures(post-op).
Percentage of time in severe hypoxemia
(SpO2 \< -5% of SpO2 target)
Time frame: AECOPD Patients: Day 1; Up to 120 minutes after start study procedures. Bariatric surgery patients: Day 1; up to 75 minutes after start study procedures(post-op).
Percentage of time in hyperoxia
(\> +5% of SpO2 target)
Time frame: AECOPD Patients: Day 1; Up to 120 minutes after start study procedures. Bariatric surgery patients: Day 1; up to 75 minutes after start study procedures(post-op).
PCO2 value after each period
Measure PCO2 with blood gases after each period
Time frame: AECOPD Patients: Day 1; 30 minutes, 60 minutes, 90 minutes, 120 minutes after start study procedures. Bariatric surgery patient: Day 1; 15 minutes and 75 minutes after start study procedures.
Plan to share: No
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François Lellouche