Institut universitaire de Cardiologie et de Pneumologie - Université Laval
Québec, Quebec, G1V 4G5, Canada
Location status: Recruiting
NCT Number: NCT04136717
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Québec, Quebec, G1V 4G5, Canada
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
(AECOPD):
Inclusion criteria
(Bariatric surgery post-op):
Exclusion criteria
5 patient with AECOPD and 5 patient with bariatric surgery will be included.
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.
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.
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.
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.
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.
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).
(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).
(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).
(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).
(> +5% of SpO2 target)
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.
Measure PCO2 with blood gases after each period
Contact information is provided by the study sponsor or research team.
François Lellouche
Other
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
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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