High Flow Nasal Cannula in Pediatric Patients After Cardiothoracic Surgery (NCT04451057) | Clinical Trial Compass
UnknownNot Applicable
High Flow Nasal Cannula in Pediatric Patients After Cardiothoracic Surgery
Japan286 participantsStarted 2020-08-11
Plain-language summary
High flow nasal cannula(HFNC) ventilation can provide such effects as wash-out effect of the carbon dioxide inside the anatomical dead space,some level of continuous airway pressure and humidified oxygen gases.
Therefore because of its physiological benefits, it has been reported that HFNC can reduce "treatment failure" after extubation in pediatric patients like preterm babies,or infants who suffer from bronchitis.
However there is no evidence showing that HFNC can reduce "treatment failure" after extubation in pediatric patients after cardiothoracic surgery.
This multi-center randomized controlled trial (RCT) involving pediatric patients after cardiothoracic surgery will be conducted to determine whether HFNC,compared with conventional oxygen therapy,after extubation can reduce the rate of"escalation of care due to treatment failure".
Who can participate
Age range
2 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:
* pediatric patients younger than two years old after cardiothoracic surgery
* pediatric patients who have been ventilated for more than 12 hours after surgery
Exclusion Criteria:
* patients with tracheostomy
* patients with do-not-resuscitate (DNR)
* patients who have be treated by noninvasive positive pressure ventilation or high flow nasal cannula before surgery
* patients who undergo unplanned extubation
* patients who have withdrawn consent from their legal guardian
* patients who don't need oxygen therapy
* patients who are planned to receive treatment with noninvasive positive pressure ventilation after extubation
* patients who are planned to inhale nitric oxide(NO) after extubation
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
the rate of"escalation of care due to treatment failure" within 72 hours after extubation
Timeframe: Final outcome measure is assessed when total patients have been recruited.Outcome measure is assessed within 72 hours after extubation.