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

Last updated: September 3, 2020
Sponsor: François Lellouche
Overall Status: Active - Recruiting

Phase

N/A

Condition

Surgery

Obesity

Treatment

N/A

Clinical Study ID

NCT04136717
2020-3275, 21796
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria (AECOPD):

  • Respiratory acidosis (pH <= 7.35 and PaCO2 > 45 mmHg), with or without NIV (last bloodgas available during hospitalization)

  • Oxygen therapy and/or SpO2 <90% room air (FiO2 <= 50% or nasal cannula <= 7 L/min tomaintain 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 apneacan be included.

Exclusion

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 ofvasopressors or inotropes)

  • Refusal to consent to the study

5 patient with AECOPD and 5 patient with bariatric surgery will be included.

Study Design

Total Participants: 10
Study Start date:
October 28, 2019
Estimated Completion Date:
April 30, 2021

Study 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.

Connect with a study center

  • Institut universitaire de Cardiologie et de Pneumologie - Université Laval

    Quebec city, Quebec G1V 4G5
    Canada

    Active - Recruiting

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