NCT04136717Active, not recruiting
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
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
Source: ClinicalTrials.gov · Last updated 5 Nov 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Active, not recruiting
- Study type
- Interventional
- Enrollment
- 10 (estimated)
- First submitted
- 15 Oct 2019
- Start date
- 28 Oct 2019
- Primary completion date
- Jul 2028
- Lead sponsor
- François Lellouche
- Diseases
- Obesity
- NCT number
- NCT04136717
What you commit to
- Study type: Interventional
- Planned participants: 10
- From 28 Oct 2019 to the primary completion date, Jul 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any contraindication to NIV (state requiring immediate endotracheal intubation, pneumothorax, recent esophagus surgery)
- Refusal to consent to the study
- 5 patient with AECOPD and 5 patient with bariatric surgery will be included.
Other illness
- Glasgow \< 12 or agitation/delirium/dementia (limiting NIV)
Age
- Age \< 18
Other
- Pregnancy
- Respiratory distress or other clinical situation requiring continuous NIV or CPAP
- Hemodynamic instability (at the beginning of the study) (increasing doses of vasopressors or inotropes)
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Institut universitaire de Cardiologie et de Pneumologie - Université Laval Coordinator of this site? Confirm its status | Québec | Canada | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.