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

Not Applicable

• Conditions: Surgery; COPD Exacerbation; Oxygen Toxicity; Abdominal Obesity

• Registration Number: NCT04136717
• Lead Sponsor: François Lellouche

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.

Study Timeline

• Study First Submitted: 2019-10-15
• Study First Submitted QC: 2019-10-22
• Study First Posted: 2019-10-23
• Study Start: 2019-10-28
• Status Verified: 2020-09
• Last Update Submitted: 2020-09-03
• Last Update Posted: 2020-09-04
• Primary Completion: 2021-01
• Study Completion: 2021-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

Not provided

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

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Primary Outcome Measures

Name	Time	Method
Percentage of time within SpO2 target	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 Outcome Measures

Name	Time	Method
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.	Measure PCO2 with blood gases after each period
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).	(\> +5% of SpO2 target)
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).	(SpO2 \< -5% of SpO2 target)
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).	(SpO2 \< -2% of SpO2 target)

Trial Locations

Locations (1)

Institut universitaire de Cardiologie et de Pneumologie - Université Laval; 🇨🇦 Quebec city, Quebec, Canada