Using FreeO2 to keep oxygen levels on target during noninvasive breathing support after COPD flare-ups or bariatric surgery
Influence of Automatic Oxygen Titration Device (FreeO2) on Percentage of Time Within Oxygen Saturation Target and Induced Hypercapnia During Noninvasive Ventilation for Patients Hospitalized for an Acute Exacerbation of COPD or a Bariatric Surgery
This trial tests whether the FreeO2 automatic oxygen controller with noninvasive breathing support can help people hospitalized for COPD exacerbations or after bariatric surgery stay within their oxygen target and avoid low or excessive oxygen and CO2 problems.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 10 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Laval University Academic / other |
| Locations | 1 site (Québec, Quebec) |
| Trial ID | NCT04136717 on ClinicalTrials.gov |
What this trial studies
This interventional single-center study compares automated oxygen titration with the FreeO2 device against standard constant-flow oxygen across noninvasive ventilation (NIV), nasal high-flow oxygen therapy (NHFOT), and CPAP modes. Participants include adults hospitalized for hypercapnic COPD exacerbations or patients recovering from bariatric surgery who use CPAP. The primary outcome is the percentage of time spent within the prespecified SpO2 target (±2%) and concurrent PCO2 values, with interventions separated by washout periods. Continuous monitoring during each intervention arm is used to quantify oxygenation stability and CO2 changes.
Who should consider this trial
Good fit: Adults hospitalized with hypercapnic COPD exacerbation who require NIV or high-flow oxygen, or adults after bariatric surgery who use CPAP (including those with obesity hypoventilation), meeting oxygenation and safety criteria, are ideal candidates.
Not a fit: Patients needing continuous invasive ventilation, those with contraindications to noninvasive ventilation, hemodynamic instability, pregnancy, or inability to tolerate NIV/CPAP are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, this approach could keep patients' oxygen levels within target more consistently, reducing episodes of hypoxemia or hyperoxia and limiting CO2 retention.
How similar studies have performed: Previous studies of automated oxygen titration devices such as FreeO2 have shown improved time in target SpO2 and reduced hyperoxia, but evidence specifically combining FreeO2 with NIV/NHFOT in hypercapnic COPD and postoperative bariatric patients is limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria (AECOPD): * 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 Inclusion Criteria (Bariatric surgery post-op): * Patients using CPAP before the surgery (obstructive sleep apnea documented). * Patients with obesity hypoventilation syndrome in addition to obstructive sleep apnea can be included. Exclusion Criteria: * 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.
Where this trial is running
Québec, Quebec
- Institut universitaire de Cardiologie et de Pneumologie - Université Laval — Québec, Quebec, Canada (Recruiting)
Study contacts
- Study coordinator: François Lellouche, MD, PhD
- Email: Francois.Lellouche@criucpq.ulaval.ca
- Phone: 418-656-8711
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.