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

NCT04136717 · tracked via the Priya Life Science Canada tracker

Sponsor

François Lellouche

Phase

Not applicable

Started

2019-10-28

Last updated

2025-09-04

Condition(s) studied

COPD ExacerbationOxygen ToxicityAbdominal ObesitySurgery

Investigational drug(s) / intervention(s)

Washout periodNIV - FreeO2Nasal High flow Oxygen therapy - FreeO2CPAP - Oxygen constant flowCPAP - FreeO2

Washout period: 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.

NIV - FreeO2: 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.

Nasal High flow Oxygen therapy - FreeO2: 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.

CPAP - Oxygen constant flow: 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.

CPAP - FreeO2: 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.

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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.

Primary outcome measure(s)

Percentage of time within SpO2 target — 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).
(SpO2 90 +/- 2%)

Trial sites (1)

Facility	City	Region	Status
Institut universitaire de Cardiologie et de Pneumologie - Université Laval	Québec	Quebec	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04136717 on ClinicalTrials.gov ↗ ← All trials in Canada