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

Overview

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.

Interventions

• Other Washout period
  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.
• Device NIV - FreeO2
  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.
• Device Nasal High flow Oxygen therapy - FreeO2
  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.
• Other CPAP - Oxygen constant flow
  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.
• Other CPAP - FreeO2
  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 measures

• 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).]

Secondary outcome measures (4)

• 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).]
• 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).]
• 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).]
• 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.]

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Crossover

Masking

Open label

Primary purpose

Treatment

Study locations

Canada · 1 center

• Institut universitaire de Cardiologie et de Pneumologie - Université Laval — Québec

Identifiers

NCT: NCT04136717 · 2020-3275, 21796

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗