Status:
RECRUITING
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
Lead Sponsor:
François Lellouche
Conditions:
COPD Exacerbation
Oxygen Toxicity
Eligibility:
All Genders
18+ years
Phase:
NA
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...
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 wit...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
October 28 2019
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2028
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT04136717
Start Date
October 28 2019
End Date
June 1 2028
Last Update
September 4 2025
Active Locations (1)
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1
Institut universitaire de Cardiologie et de Pneumologie - Université Laval
Québec, Quebec, Canada, G1V 4G5