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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

Primary Purpose

COPD Exacerbation, Oxygen Toxicity, Abdominal Obesity

Status

Unknown status

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Washout period

NIV - FreeO2

Nasal High flow Oxygen therapy - FreeO2

CPAP - Oxygen constant flow

CPAP - FreeO2

About this trial

This is an interventional treatment trial for COPD Exacerbation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

Institut universitaire de Cardiologie et de Pneumologie - Université LavalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Arm Label

COPD patients

Bariatric surgery patients

Arm Description

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

Obese patients after gastric surgery under CPAP.

Outcomes

Primary Outcome Measures

Percentage of time within SpO2 target

(SpO2 90 +/- 2%)

Secondary Outcome Measures

Percentage of time in hypoxemia

(SpO2 < -2% of SpO2 target)

Percentage of time in severe hypoxemia

(SpO2 < -5% of SpO2 target)

Percentage of time in hyperoxia

(> +5% of SpO2 target)

PCO2 value after each period

Measure PCO2 with blood gases after each period

Full Information

NCT ID

NCT04136717

First Posted

October 15, 2019

Last Updated

September 3, 2020

Sponsor

François Lellouche

1. Study Identification

Unique Protocol Identification Number

NCT04136717

Brief 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

Official 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

Study Type

Interventional

2. Study Status

Record Verification Date

September 2020

Overall Recruitment Status

Unknown status

Study Start Date

October 28, 2019 (Actual)

Primary Completion Date

January 2021 (Anticipated)

Study Completion Date

April 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

François Lellouche

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

Detailed Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COPD Exacerbation, Oxygen Toxicity, Abdominal Obesity, Surgery

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

COPD patients

Arm Type

Other

Arm Description

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

Arm Title

Bariatric surgery patients

Arm Type

Other

Arm Description

Obese patients after gastric surgery under CPAP.

Intervention Type

Other

Intervention Name(s)

Washout period

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

NIV - FreeO2

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Nasal High flow Oxygen therapy - FreeO2

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

CPAP - Oxygen constant flow

Intervention Description

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.

Intervention Type

Other

Intervention Name(s)

CPAP - FreeO2

Intervention Description

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 Information:

Title

Percentage of time within SpO2 target

Description

(SpO2 90 +/- 2%)

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).

Secondary Outcome Measure Information:

Title

Percentage of time in hypoxemia

Description

(SpO2 < -2% of 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).

Title

Percentage of time in severe hypoxemia

Description

(SpO2 < -5% of 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).

Title

Percentage of time in hyperoxia

Description

(> +5% of 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).

Title

PCO2 value after each period

Description

Measure PCO2 with blood gases 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.

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

François Lellouche, MD, PhD

Phone

418-656-8711

Ext

3572

Francois.Lellouche@criucpq.ulaval.ca

First Name & Middle Initial & Last Name or Official Title & Degree

Miguel Trottier, MD, CM

miguel.trottier.1@ulaval.ca

Facility Information:

Facility Name

Institut universitaire de Cardiologie et de Pneumologie - Université Laval

City

Quebec city

State/Province

Quebec

ZIP/Postal Code

G1V 4G5

Country

Canada

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

François Lellouche

Phone

418-656-8711

Ext

3572

12. IPD Sharing Statement

Plan to Share IPD

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