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

Plain Language Summary

Simplified for easier understanding

This study is testing an automated oxygen delivery device called FreeO2, which adjusts oxygen levels in real time during non-invasive breathing support (such as NIV or CPAP), for two groups: people hospitalized for a worsening of COPD (chronic obstructive pulmonary disease), and people who use CPAP after bariatric (weight loss) surgery. **You may be eligible if...** - For COPD group: you are hospitalized with an acute worsening of COPD and need oxygen therapy, and have certain blood gas (CO2 and acid) measurements - For bariatric surgery group: you use CPAP at home before surgery (for sleep apnea) or have obesity-related hypoventilation syndrome - You are 18 or older **You may NOT be eligible if...** - You are under 18 or pregnant - You are in severe respiratory distress requiring constant breathing support - You have hemodynamic instability (worsening blood pressure requiring increasing medications) - You have a contraindication to non-invasive ventilation (such as pneumothorax or recent esophageal surgery) - You refuse to consent Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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.