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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

ConditionsCOPD ExacerbationOxygen ToxicityAbdominal ObesitySurgery
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorFrançois Lellouche

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

Age < 18

Pregnancy

Respiratory distress or other clinical situation requiring continuous NIV or CPAP

Glasgow < 12 or agitation/delirium/dementia (limiting NIV)

Trial design

Design model

Crossover

Treatments tested in this trial

  • Washout period

    Other intervention

    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.

  • NIV - FreeO2

    Device

    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.

  • Nasal High flow Oxygen therapy - FreeO2

    Device

    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.

  • CPAP - Oxygen constant flow

    Other intervention

    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.

  • CPAP - FreeO2

    Other intervention

    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.

Treatment groups

10 Participants
are divided into 2 treatment groups
Group A: COPD patientsOther 3 interventions
Group B: Bariatric surgery patientsOther 2 interventions

Trial outcomes

Primary outcomes

1

Percentage of time within SpO2 target

(SpO2 90 +/- 2%)

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 outcomes

1

Percentage of time in hypoxemia

(SpO2 \< -2% of 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).
2

Percentage of time in severe hypoxemia

(SpO2 \< -5% of 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).
3

Percentage of time in hyperoxia

(\> +5% of 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).
4

PCO2 value after each period

Measure PCO2 with blood gases 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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

François Lellouche

Lead sponsor

Laval University

Sponsor institution

Source ClinicalTrials.gov
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