Recruiting

FreeO2

Sponsor:

François Lellouche

Code:

NCT04136717

Conditions

COPD Exacerbation

Oxygen Toxicity

Abdominal Obesity

Surgery

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Washout period

NIV - FreeO2

Nasal High flow Oxygen therapy - FreeO2

CPAP - Oxygen constant flow

CPAP - FreeO2

Study Details

Brief 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.

Conditions

COPD Exacerbation

Oxygen Toxicity

Abdominal Obesity

Surgery

Study ID

NCT04136717

Start date

Oct 28, 2019

Status verified date

Aug, 2025

Completion date

Jun, 2028

Anticipated

Primary completion date

Jul, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

10 participants

Anticipated

Allocation

Non randomized

Intervention Model

Crossover

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

other: COPD patients

Patients with acute exacerbation of COPD and respiratory acidosis under oxygen therapy.

other: Bariatric surgery patients

Obese patients after gastric surgery under CPAP.

Interventions

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.

Primary outcome measure

  • Percentage of time within 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). ]

Central Contacts and Locations

Central contacts

François Lellouche, MD, PhD

418-656-8711Francois.Lellouche@criucpq.ulaval.ca

Miguel Trottier, MD, CM

miguel.trottier.1@ulaval.ca

Locations

Institut universitaire de Cardiologie et de Pneumologie - Université Laval

Recruiting

Québec, Quebec, Canada, G1V 4G5

Contacts

François Lellouche

418-656-8711

More Information

Sponsor

François Lellouche

Last update posted

Sep 4, 2025

Last verified

Aug, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by François Lellouche on 2025-09-04.