NCT04136717 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 |
| Status | Recruiting |
| Phase | — |
| Sponsor | François Lellouche |
| Condition | COPD Exacerbation |
| Study Type | INTERVENTIONAL |
| Enrollment | 10 participants |
| Start Date | 2019-10-28 |
| Primary Completion | 2027-07 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 10 participants in total. It began in 2019-10-28 with a primary completion date of 2027-07.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT04136717 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying COPD Exacerbation. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT04136717 currently recruiting?
Yes, NCT04136717 is actively recruiting participants. Contact the research team at Francois.Lellouche@criucpq.ulaval.ca for enrollment information.
Where is the NCT04136717 trial being conducted?
This trial is being conducted at Québec, Canada.
Who is sponsoring the NCT04136717 clinical trial?
NCT04136717 is sponsored by François Lellouche. The trial plans to enroll 10 participants.
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