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
NCT ID: NCT04136717
Last Updated: 2025-09-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
NA
10 participants
INTERVENTIONAL
2019-10-28
2028-06-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
EPO2-PV: Evaluation of Pre-Oxygenation Conditions in Morbidly Obese Volunteer: Effect of Position and Ventilation Mode
NCT02121808
Does High Intraoperative Inspired Oxygen Reduce Postoperative Arterial Oxygen Saturation?
NCT00715741
Intra-Operative Modified Ventilator Mechanical Power in Laparoscopic Bariatric Surgeries
NCT07065370
Effect of Positive End Expiratory Pressure at the Time of Induction in Morbidly Obese Patients
NCT03024658
Preoxygenation Optimisation in Obese Patients
NCT03106441
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
CROSSOVER
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
COPD patients
Patients with acute exacerbation of COPD and respiratory acidosis under oxygen therapy.
Washout 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.
NIV - 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.
Nasal 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.
Bariatric surgery patients
Obese patients after gastric surgery under CPAP.
CPAP - 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.
CPAP - 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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Washout 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.
NIV - 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.
Nasal 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.
CPAP - 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.
CPAP - 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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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).
* Patients with obesity hypoventilation syndrome in addition to obstructive sleep apnea can be included.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
François Lellouche
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
François Lellouche
Principal Investigator
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Institut universitaire de Cardiologie et de Pneumologie - Université Laval
Québec, Quebec, Canada
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
François Lellouche
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2020-3275, 21796
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.