Outcomes of a Nurse-led High-flow Nasal Cannula Weaning Protocol in Pediatric Critical Bronchiolitis Patients

Status: Recruiting
Location: See all (6) locations...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Bronchiolitis is a leading cause of pediatric hospital admissions. Despite its limited clinical benefits, the use of HFNC in children with bronchiolitis is increasing. Previous studies using quality improvement (QI) methodologies have successfully reduced HFNC usage through weaning protocols and trials of standard oxygen therapy. This study involves implementing an HFNC initiation and weaning protocol at Aydın Maternity and Children's Hospital, involving infants aged 1-24 months admitted with bronchiolitis.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1 month
Maximum Age: 2
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Turkey
Aydin Obstetric and pediatrics Hospital
RECRUITING
Aydin
Erzurum Regional Research and Training Hospital
NOT_YET_RECRUITING
Erzurum
Acibadem University, Acibadem Altunizade Hospital
RECRUITING
Istanbul
Cam Sakura Research and Training Hospital
RECRUITING
Istanbul
Istanbul Aydin University
NOT_YET_RECRUITING
Istanbul
The Health Sciences University Izmir Behçet Uz Child Health and Diseases Research and Training Hospital
RECRUITING
Izmir
Contact Information
Primary
Hasan Agin, Prof.Dr.
Hasanagin@gmail.com
+905362013162
Time Frame
Start Date: 2024-10-01
Estimated Completion Date: 2025-06
Participants
Target number of participants: 150
Treatments
No_intervention: Standard Protocol Group
Control Arm (Pre-Protocol Implementation):~This group includes patients aged 1-24 months receiving HFNC (High-Flow Nasal Cannula) therapy for bronchiolitis based on the conventional, non-standardized approach. HFNC weaning decisions in this group are made at the treating clinicians' discretion, without following a formal protocol. Decisions are influenced by clinical presentation, respiratory effort, and clinician experience. This group serves as the control arm, representing the current standard of care.
Active_comparator: New Protocol Group
This group includes patients aged 1-24 months who are randomized to receive HFNC therapy under a newly implemented standardized weaning protocol, developed using Quality Improvement (QI) methodology. The protocol involves a structured, criteria-based weaning approach with clear steps for reducing HFNC support, focusing on clinical indicators like respiratory rate, work of breathing, and oxygen saturation. A multidisciplinary team, including pediatricians, nurses, and respiratory therapists, created this protocol, and staff received training before implementation.
Related Therapeutic Areas
Sponsors
Leads: Dr. Behcet Uz Children's Hospital
Collaborators: Hamilton Medical AG

This content was sourced from clinicaltrials.gov