Nurse-led High-flow Nasal Cannula Weaning Protocol in Pediatric Intensive Care Unit

NCT06621641 | Completed DMC

• 1 other identifier: 02024/GOA-80
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 6

Brief 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.

Conditions

Bronchiolitis; Respiratory Failure (Pediatric Patients); High Flow Nasal Cannula

Keywords

bronchiolitis; high flow nasal cannula; Quality Improvement (QI); HFNC protocol

Outcome Measures

Primary Outcomes (4)

• HFNC duration

  HFNC duration calculated during intensive care hospitalization

  Through study completion, an average of 1 year

• Hospital length of stay

  Total hospital stay time including intensive care unit

  Through study completion, an average of 1 year

• Need for non-invasive ventilation

  It will be compared whether there is a difference between the two groups in terms of niv needs.

  Through study completion, an average of 1 year

• Associated costs

  HFNC costs and total hospitalization costs will be calculated

  Through study completion, an average of 1 year

Study Arms (2)

Standard Protocol Group

NO INTERVENTION

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.

New Protocol Group

ACTIVE COMPARATOR

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.

Behavioral: The new HFNC weaning protocol

Interventions

The new HFNC weaning protocol BEHAVIORAL

Patients will be randomly assigned to two groups: one following the new HFNC weaning protocol and another using the standard care protocol. The new protocol includes stepwise flow reduction based on the patient's clinical stability and uses the Respiratory Assessment Scale (RAS) to monitor weaning progress. The protocol emphasizes a multidisciplinary approach involving pediatricians, nurses, and respiratory therapists, with consistent training and application of weaning criteria

New Protocol Group

Eligibility Criteria

• Age: 1 Month - 24 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Dr. Behcet Uz Children's Hospital: lead
• Hamilton Medical AG: collaborator

Study Sites (6)

Aydin Obstetric and pediatrics Hospital

Aydin, 09020, Turkey (Türkiye)

Location

Erzurum Regional Research and Training Hospital

Erzurum, 25180, Turkey (Türkiye)

Location

Cam Sakura Research and Training Hospital

Istanbul, 34001, Turkey (Türkiye)

Location

Acibadem University, Acibadem Altunizade Hospital

Istanbul, Turkey (Türkiye)

Location

Istanbul Aydin University

Istanbul, Turkey (Türkiye)

Location

The Health Sciences University Izmir Behçet Uz Child Health and Diseases Research and Training Hospital

Izmir, Turkey (Türkiye)

Location

Related Publications (9)

• Huang JX, Colwell B, Vadlaputi P, Sauers-Ford H, Smith BJ, McKnight H, Witkowski J, Padovani A, Aghamohammadi S, Tzimenatos L, Beck Rn S, Reneau K, Nill B, Harbour D, Pegadiotes J, Natale J, Hamline M, Siefkes H. Protocol-Driven Initiation and Weaning of High-Flow Nasal Cannula for Patients With Bronchiolitis: A Quality Improvement Initiative. Pediatr Crit Care Med. 2023 Feb 1;24(2):112-122. doi: 10.1097/PCC.0000000000003136. Epub 2022 Dec 16.

  PMID: 36661418 BACKGROUND

• Ralston SL, Lieberthal AS, Meissner HC, Alverson BK, Baley JE, Gadomski AM, Johnson DW, Light MJ, Maraqa NF, Mendonca EA, Phelan KJ, Zorc JJ, Stanko-Lopp D, Brown MA, Nathanson I, Rosenblum E, Sayles S 3rd, Hernandez-Cancio S; American Academy of Pediatrics. Clinical practice guideline: the diagnosis, management, and prevention of bronchiolitis. Pediatrics. 2014 Nov;134(5):e1474-502. doi: 10.1542/peds.2014-2742.

  PMID: 25349312 BACKGROUND

• Kepreotes E, Whitehead B, Attia J, Oldmeadow C, Collison A, Searles A, Goddard B, Hilton J, Lee M, Mattes J. High-flow warm humidified oxygen versus standard low-flow nasal cannula oxygen for moderate bronchiolitis (HFWHO RCT): an open, phase 4, randomised controlled trial. Lancet. 2017 Mar 4;389(10072):930-939. doi: 10.1016/S0140-6736(17)30061-2. Epub 2017 Feb 2.

  PMID: 28161016 BACKGROUND

• Franklin D, Babl FE, Schlapbach LJ, Oakley E, Craig S, Neutze J, Furyk J, Fraser JF, Jones M, Whitty JA, Dalziel SR, Schibler A. A Randomized Trial of High-Flow Oxygen Therapy in Infants with Bronchiolitis. N Engl J Med. 2018 Mar 22;378(12):1121-1131. doi: 10.1056/NEJMoa1714855.

  PMID: 29562151 BACKGROUND

• Collins C, Chan T, Roberts JS, Haaland WL, Wright DR. High-Flow Nasal Cannula in Bronchiolitis: Modeling the Economic Effects of a Ward-Based Protocol. Hosp Pediatr. 2017 Jul 25:hpeds.2016-0167. doi: 10.1542/hpeds.2016-0167. Online ahead of print.

  PMID: 28743698 BACKGROUND

• Treasure JD, Hubbell B, Statile AM. Enough Is Enough: Quality Improvement to Deimplement High-Flow Nasal Cannula in Bronchiolitis. Hosp Pediatr. 2021 Apr;11(4):e54-e56. doi: 10.1542/hpeds.2021-005849. Epub 2021 Mar 22. No abstract available.

  PMID: 33753361 BACKGROUND

• Franklin D, Schibler A. Rising Intensive Care Costs in Bronchiolitis Infants-Is Nasal High Flow the Culprit? Pediatr Crit Care Med. 2022 Mar 1;23(3):218-222. doi: 10.1097/PCC.0000000000002900. No abstract available.

  PMID: 35238842 BACKGROUND

• Charvat C, Jain S, Orenstein EW, Miller L, Edmond M, Sanders R. Quality Initiative to Reduce High-Flow Nasal Cannula Duration and Length of Stay in Bronchiolitis. Hosp Pediatr. 2021 Apr;11(4):309-318. doi: 10.1542/hpeds.2020-005306. Epub 2021 Mar 22.

  PMID: 33753362 BACKGROUND

• Peterson RJ, Hassumani DO, Hole AJ, Slaven JE, Tori AJ, Abu-Sultaneh S. Implementation of a High-Flow Nasal Cannula Management Protocol in the Pediatric ICU. Respir Care. 2021 Apr;66(4):591-599. doi: 10.4187/respcare.08284. Epub 2020 Sep 11.

  PMID: 32917844 BACKGROUND

MeSH Terms

Conditions

Bronchiolitis; Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Bronchitis; Respiratory Tract Infections; Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiration Disorders

Study Officials

• Hasan Agin, Prof.Dr.

  Dr. Behcet Uz Children's Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. Doctor

Model Details: A prospective, randomized controlled trial will be conducted to evaluate the effectiveness of a newly developed HFNC (High-Flow Nasal Cannula) weaning protocol in infants aged 1-24 months with bronchiolitis, compared to the standard weaning protocol. Participants: Infants aged 1-24 months admitted with bronchiolitis and receiving HFNC therapy will be included. Exclusion criteria include infants born before 32 weeks of gestation or those with cardiopulmonary, genetic, congenital, or neuromuscular abnormalities. Randomization and Groups: Participants will be randomly assigned to one of two groups: Control Group: Will follow the existing HFNC weaning protocol. Intervention Group: The intervention group will follow the newly developed multidisciplinary HFNC weaning protocol.

Study Record Dates

• First Submitted: September 20, 2024
• First Posted: October 1, 2024
• Study Start: October 1, 2024
• Primary Completion: May 30, 2025
• Study Completion: June 30, 2025
• Last Updated: November 25, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

TU (6)