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

François Lellouche

Status: Unknown

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

Treatments: Other: Washout period; Device: Nasal High flow Oxygen therapy - FreeO2; Other: CPAP - FreeO2; Other: CPAP - Oxygen constant flow; Device: NIV - FreeO2

Study type: Interventional

Funder types: Other

Identifiers

NCT04136717

2020-3275, 21796

Details and patient eligibility

About

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.

Full 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.

Enrollment: 10 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

COPD patients

Other group

Description:

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

Treatment:

Device: NIV - FreeO2

Other: Washout period

Device: Nasal High flow Oxygen therapy - FreeO2

Bariatric surgery patients

Other group

Description:

Obese patients after gastric surgery under CPAP.

Treatment:

Other: CPAP - FreeO2

Other: CPAP - Oxygen constant flow