Using high flow nasal cannula for kids after heart surgery
High Flow Nasal Cannula in Pediatric Patients After Cardiothoracic Surgery:A Randomized Controlled Trial
This study is testing if a special type of oxygen therapy called high flow nasal cannula can help young children breathe better after heart surgery compared to regular oxygen therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 286 (estimated) |
| Ages | N/A to 2 Years |
| Sex | All |
| Sponsor | Osaka University Academic / other |
| Locations | 1 site (Osaka) |
| Trial ID | NCT04451057 on ClinicalTrials.gov |
What this trial studies
This multi-center randomized controlled trial aims to evaluate the effectiveness of high flow nasal cannula (HFNC) therapy compared to conventional oxygen therapy in reducing treatment failure after extubation in pediatric patients who have undergone cardiothoracic surgery. The study will enroll 380 children under two years old from various intensive care units in Japan. Participants will be randomly assigned to receive either HFNC or standard oxygen therapy immediately after extubation, and their outcomes will be monitored for 72 hours. The goal is to determine if HFNC can lower the need for escalation of care due to treatment failure.
Who should consider this trial
Good fit: Ideal candidates are pediatric patients under two years old who have been ventilated for more than 12 hours following cardiothoracic surgery.
Not a fit: Patients who have tracheostomy, do-not-resuscitate orders, or those who do not require oxygen therapy will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve recovery outcomes for pediatric patients after heart surgery by reducing the rate of treatment failure.
How similar studies have performed: While HFNC has shown promise in other pediatric populations, this specific application in post-cardiothoracic surgery patients is novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Osaka
- Department of Anesthesiology and Intensive Care Medicine, Osaka University — Osaka, Japan (Recruiting)
Study contacts
- Study coordinator: Takeshi Yoshida, MDPhD
- Email: takeshiyoshida@hp-icu.med.osaka-u.ac.jp
- Phone: +81668795820
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.