Abdominal Obesity, COPD Exacerbation, Oxygen Toxicity, Surgery
Conditions
Brief 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.
Detailed 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.
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.
Sponsors
François Lellouche
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of time within SpO2 target | 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%) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of time in hypoxemia | 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) |
| Percentage of time in severe hypoxemia | 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) |
| Percentage of time in hyperoxia | 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) |
| PCO2 value after each period | 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 |
Countries
Canada
Contacts
Primary ContactFrançois Lellouche, MD, PhD
Backup ContactMiguel Trottier, MD, CM
Outcome results
None listed