Nurse-led protocol for weaning high-flow nasal cannula in pediatric patients
Outcomes of a Nurse-led High-flow Nasal Cannula Weaning Protocol in Pediatric Critical Bronchiolitis Patients
This study is testing a new plan for safely reducing high-flow nasal oxygen support in babies with bronchiolitis to see if it helps them get better faster and reduces hospital costs.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 150 (estimated) |
| Ages | 1 Month to 24 Months |
| Sex | All |
| Sponsor | Dr. Behcet Uz Children's Hospital Academic / other |
| Locations | 6 sites (Aydın and 5 other locations) |
| Trial ID | NCT06621641 on ClinicalTrials.gov |
What this trial studies
This study implements a high-flow nasal cannula (HFNC) initiation and weaning protocol for infants aged 1-24 months admitted with bronchiolitis at Aydın Maternity and Children's Hospital. It aims to address the increasing use of HFNC despite limited clinical benefits by utilizing quality improvement methodologies to standardize treatment. A multidisciplinary team will evaluate patients using the Respiratory Assessment Scale (RAS) to classify severity and compare outcomes such as HFNC duration, hospital stay, and associated costs before and after the protocol implementation.
Who should consider this trial
Good fit: Ideal candidates are infants aged 1-24 months hospitalized in the pediatric intensive care unit with moderate to severe respiratory distress requiring HFNC.
Not a fit: Patients with significant comorbidities, such as congenital abnormalities or those requiring immediate noninvasive ventilation, may not benefit from this study.
Why it matters
Potential benefit: If successful, this protocol could reduce unnecessary HFNC usage and hospital stays for pediatric patients with bronchiolitis.
How similar studies have performed: Previous studies using quality improvement methodologies have shown success in reducing HFNC usage through weaning protocols.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients older than 1 month and younger than 24 months of age; hospitalized at the PICU with the intention of treatment with HFNC at least for the upcoming 4 hours * Patients with moderate and severe RAS(Respiratory Assessment Scale) requiring HFNC * Written informed consent signed and dated by the patient or one relative in case that the patient is unable to consent, after full explanation of the study by the investigator and prior to study participation Exclusion Criteria: * İnfants born before 32 weeks of gestation or those with cardiopulmonary, genetic, congenital, or neuromuscular abnormalities. * Patient with an indication for immediate noninvasive ventilation (NIV) * Patients deemed at high risk for the need for non-invasive mechanical ventilation within the next 4 hours * Hemodynamic instability
Where this trial is running
Aydın and 5 other locations
- Aydin Obstetric and pediatrics Hospital — Aydın, Turkey (Recruiting)
- Erzurum Regional Research and Training Hospital — Erzurum, Turkey (Not_yet_recruiting)
- Cam Sakura Research and Training Hospital — Istanbul, Turkey (Recruiting)
- Acibadem University, Acibadem Altunizade Hospital — Istanbul, Turkey (Recruiting)
- Istanbul Aydin University — Istanbul, Turkey (Not_yet_recruiting)
- The Health Sciences University Izmir Behçet Uz Child Health and Diseases Research and Training Hospital — İzmir, Turkey (Recruiting)
Study contacts
- Study coordinator: Hasan Agin, Prof.Dr.
- Email: Hasanagin@gmail.com
- Phone: +905362013162
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.