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NCT Number: 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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Institut universitaire de Cardiologie et de Pneumologie - Université Laval

Québec, Quebec, G1V 4G5, Canada

Location status: Recruiting

Location contact

François Lellouche

CONTACT

418-656-8711 ext. 3572

About this study

Bariatric surgery patients:

The main objective of this study is to evaluate the time spent in the SpO2 target (+/- 2% SpO2 target) and partial pressure of carbon dioxide (PCO2) values on patients with morbid obesity after bariatric surgery.

COPD patients:

The main objective of this study is to evaluate the time spent in the SpO2 target (+/- 2% SpO2 target) and PCO2 values on patients with exacerbation of COPD (hypercapnic patients) with different ventilatory supports (NIV and NHFOT) associated with FreeO2.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

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.

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.

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.

Primary outcomes

  1. 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).

    (SpO2 90 +/- 2%)

Secondary outcomes

  1. Percentage of time in hypoxemia

    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).

    (SpO2 < -2% of SpO2 target)

  2. Percentage of time in severe hypoxemia

    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).

    (SpO2 < -5% of SpO2 target)

  3. Percentage of time in hyperoxia

    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).

    (> +5% of SpO2 target)

  4. PCO2 value after each period

    Time frame: 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.

    Measure PCO2 with blood gases after each period

Study contacts

Contact information is provided by the study sponsor or research team.

François Lellouche, MD, PhD

CONTACT

[email protected]

418-656-8711 ext. 3572

Miguel Trottier, MD, CM

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

François Lellouche

Other

Registry information

Official study title

Influence of Automatic Oxygen Titration Device (FreeO2) on Percentage of Time Within Oxygen Saturation Target and Induced Hypercapnia During Noninvasive Ventilation for Patients Hospitalized for an Acute Exacerbation of COPD or a Bariatric Surgery

Important dates

Study start
2019
Primary completion
2027
Study completion
2028
First posted
Oct 23, 2019
Registry last updated
Sep 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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