Interest of High Flow Nasal Cannula Oxygen Therapy in Pediatric Intensive Care Unit (NCT03505814) | Clinical Trial Compass
UnknownNot Applicable
Interest of High Flow Nasal Cannula Oxygen Therapy in Pediatric Intensive Care Unit
Tunisia126 participantsStarted 2017-03-01
Plain-language summary
monocentric randomized controlled trial starting from Mars 2017, recruitment is still ongoing. Patients aged between 0-45 days needing mechanical ventilation (MV) with tracheal intubation were included random assignation in two groups for post-extubation management: Group Optiflow (GO) for patients receiving High Flow Nasal Cannula Oxygen Therapy HNFC and Control Group (CG) for conventional treatment.
Patients were evaluated during the first 72h following extubation. Primary endpoint was the incidence of reintubation. Secondary endpoints were incidence of post-extubation respiratory failure, time to reintubate and weaning time from oxygen. Respiratory and hemodynamic parameters were assessed and compared between the two groups upon extubation, after 2 hours (H2), at H6, H12, H24, H36, H48 and H72. Length of stay (LOS) and mortality were also estimated.
Who can participate
Age range
1 Day – 45 Days
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:
* need for mechanical ventilation
* tracheal intubation
* surgical intensive care admission
* availability of extubation criteria
Exclusion Criteria:
* prior extubation and mechanical ventilation to the actual episode
* weaning failure due to neurological status
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
reintubation rate
Timeframe: 72 hours following prior weaning and extubation