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 | Recruiting

• 1 other identifier: 2020-3275, 21796
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• Percentage of time within SpO2 target

  (SpO2 90 +/- 2%)

  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).

Secondary Outcomes (4)

• Percentage of time in hypoxemia

  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).

• Percentage of time in severe hypoxemia

  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).

• Percentage of time in hyperoxia

  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).

• PCO2 value after each period

  AECOPD Patients: Day 1; 30 minutes, 60 minutes, 90 minutes, 120 minutes after start study procedures. Bariatric surgery patient: Day 1; 15 minutes and 75 minutes after start study procedures.

Study Arms (2)

COPD patients

OTHER

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

Other: Washout period; Device: NIV - FreeO2; Device: Nasal High flow Oxygen therapy - FreeO2

Bariatric surgery patients

OTHER

Obese patients after gastric surgery under CPAP.

Other: CPAP - Oxygen constant flow; Other: CPAP - FreeO2

Interventions

Washout period OTHER

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.

COPD patients

NIV - FreeO2 DEVICE

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.

COPD patients

Nasal High flow Oxygen therapy - FreeO2 DEVICE

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.

COPD patients

CPAP - Oxygen constant flow OTHER

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.

Bariatric surgery patients

CPAP - FreeO2 OTHER

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.

Bariatric surgery patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• François Lellouche: lead

Study Sites (1)

Institut universitaire de Cardiologie et de Pneumologie - Université Laval

Québec, Quebec, G1V 4G5, Canada

RECRUITING

MeSH Terms

Conditions

Obesity, Abdominal

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Central Study Contacts

François Lellouche, MD, PhD

CONTACT

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

Miguel Trottier, MD, CM

CONTACT

miguel.trottier.1@ulaval.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 15, 2019
• First Posted: October 23, 2019
• Study Start: October 28, 2019
• Primary Completion (Estimated): July 1, 2027
• Study Completion (Estimated): June 1, 2028
• Last Updated: September 4, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)