RecruitingNot ApplicableNCT04136717

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

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

Sponsor

François Lellouche

Enrollment

10 participants

Start Date

Oct 28, 2019

Study Type

INTERVENTIONAL

Conditions

Surgery COPD Exacerbation Abdominal Obesity Oxygen Toxicity

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

Min Age: 18 Years

Inclusion Criteria5

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
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 Criteria8

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

Interventions

OTHERWashout 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.

DEVICENIV - 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.

DEVICENasal 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.

OTHERCPAP - 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.

OTHERCPAP - 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.