Influence of FreeO2 on Percentage of Time Within Oxygen Saturation Target Using Noninvasive Venti… (NCT04136717) | Clinical Trial Compass
RecruitingNot Applicable
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
Canada10 participantsStarted 2019-10-28
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of time within SpO2 target
Timeframe: 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).