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
Recruiting · NCT04136717 · Interventional (participants receive a specific treatment) · Lead sponsor: François Lellouche
View the official record on ClinicalTrials.gov →Interventions studied
CPAP - FreeO2CPAP - Oxygen constant flowNIV - FreeO2Nasal High flow Oxygen therapy - FreeO2Washout period
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
- patient with AECOPD and 5 patient with bariatric surgery will be included.
Where it is running
1 location listed.
- Institut universitaire de Cardiologie et de Pneumologie - Université Laval - Québec, Quebec, Canada