Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT04136717

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

Led by François Lellouche · Updated on 2025-09-04

10

Participants Needed

1

Research Sites

448 weeks

Total Duration

On this page

AI-Summary

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults with respiratory acidosis (pH ≤ 7.35 and PaCO2 > 45 mmHg), with or without NIV
  • Receiving oxygen therapy and/or have SpO2 below 90% on room air
  • Using high flow nasal cannula at flow rates up to 30 L/min (AECOPD patients)
  • Patients using CPAP before bariatric surgery due to obstructive sleep apnea
  • Patients with obesity hypoventilation syndrome alongside obstructive sleep apnea (bariatric surgery patients)
Not Eligible

You will not qualify if you...

  • Younger than 18 years old
  • Pregnant individuals
  • Respiratory distress or conditions requiring continuous NIV or CPAP
  • Glasgow coma scale below 12 or agitation/delirium/dementia limiting NIV use
  • Any contraindication to NIV such as need for immediate intubation, pneumothorax, or recent esophagus surgery
  • Hemodynamic instability at study start (increasing vasopressors or inotropes)
  • Refusal to consent to participate in the study

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Institut universitaire de Cardiologie et de Pneumologie - Université Laval

Québec, Quebec, Canada, G1V 4G5

Actively Recruiting

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Research Team

F

François Lellouche, MD, PhD

CONTACT

M

Miguel Trottier, MD, CM

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

CROSSOVER

Primary Purpose

TREATMENT

Number of Arms

2

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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 | DecenTrialz