Respiratory Support and Treatment for Efficient and Cost-Effective Care

NCT05909566 | Recruiting DMC FDA Device

• 1 other identifier: STUDY23010030
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

Brief Summary

This project aims to answer the essential questions about the management of acute, pediatric respiratory illness, accelerate recovery from these all-too-common diseases, curb unnecessary costs of care, and demonstrate UPMC Children's Hospital of Pittsburgh's capabilities as the premier, world-class leader in the arena of pediatric learning healthcare systems. REST EEC will focus on the question of whether clinical decision support (CDS) facilitates the standardization of the initiation and weaning of heated high flow nasal cannula (HHFNC) for bronchiolitis.REST EEC will focus on whether the application of CDS improves adherence to a standardized guideline and leads to improved patient-centered outcomes.

Conditions

Bronchiolitis

Outcome Measures

Primary Outcomes (1)

• HFNC duration

  Amount of time patient is on HFNC

  Timeframe consists of a start time of either randomization or the last documentation of positive pressure ventilation (whichever is later) and the last documentation of HFNC in the electronic flowsheet, up to 30 days

Secondary Outcomes (8)

• Respiratory support free days

  From date the start of respiratory support until the first documented respiratory support free day, up to 30 days

• Hospital length of stay

  From date of admission until discharge or date of death from any cause, whichever came first, assessed up to 90 days.

• Organ support free days

  From date of admission until the first day of ICU-based respiratory or cardiovascular organ support or discharge or date of death from any case, whichever came first, assessed up to 30 days

• Time to oral intake

  From date of ending HHFNC until first documented oral intake, assessed up to 30 days

• Ostensible respiratory distress measured by a respiratory severity score

  Through study completion, an average of 1 week

Study Arms (2)

HHFNC + Clinical decision Support

EXPERIMENTAL

Standardized HHFNC weaning coupled with clinical decision support consisting of electronic record embedded reminders to the clinical team to wean HHFNC

Other: Clinical Decision Support (CDS); Device: HHFNC Weaning

HHFNC Weaning

ACTIVE COMPARATOR

Team does not receive clinical decision support reminders to wean the HHFNC

Other: Clinical Decision Support (CDS); Device: HHFNC Weaning

Interventions

Clinical Decision Support (CDS) OTHER

Education to front line clinicians and staff on standardized implementation and weaning of HHFNC and standardized assessments of patient work of breathing. HHFNC implementation and weaning strategies will be based on age-specific practices recommended by the American Academy of Pediatrics. Education will be undertaken by dedicated clinical educators.

HHFNC + Clinical decision Support; HHFNC Weaning

HHFNC Weaning DEVICE

Wean patient off oxygen and flow as oxygenation and work of breathing improves.

HHFNC + Clinical decision Support; HHFNC Weaning

Eligibility Criteria

• Age: Up to 2 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• \<2 years of age Bronchiolitis WOB Score \>2

You may not qualify if:

• Immunocompromised
• Immunosuppressed
• Chronic lung disease
• Congenital heart disease with baseline cardiorespiratory manifestations

Sponsors & Collaborators

• Christopher Horvat: lead
• Beckwith Foundation: collaborator

Study Sites (1)

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

RECRUITING

Related Publications (1)

• Horvat CM, Suresh S, James N, Aneja RK, Au AK, Berry S, Blumer A, Bricker K, Clark RSB, Dolinich H, Hahner S, Jockel C, Kalivoda J, Loar I, Marasco D, Marcinick A, Marroquin O, O'brien J, Pelletier J, Ramgopal S, Venkataraman S, Angus DC, Butler G. A randomized, embedded, pragmatic, Bayesian clinical trial examining clinical decision support for high flow nasal cannula management in children with bronchiolitis: design and statistical analysis plan. Trials. 2024 Jul 16;25(1):484. doi: 10.1186/s13063-024-08327-y.

  PMID: 39014495 DERIVED

MeSH Terms

Conditions

Bronchiolitis

Condition Hierarchy (Ancestors)

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

Study Officials

• Christopher Horvat, MD

  UPMC Children's Hospital of Pittsburgh

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christopher Horvat, MD

CONTACT

4126925298; christopher.horvat@chp.edu

India Loar

CONTACT

4126480613; idl1@pitt.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Model Details: We will be providing clinical decision support tools for children receiving HHFNC for bronchiolitis, testing the impact of decision support compared to usual care in a pragmatic randomized trial. All subjects will receive standard of care. Decisions regarding management will be at the discretion of the treating provider and will not be restricted or altered in any way.

Study Record Dates

• First Submitted: May 24, 2023
• First Posted: June 18, 2023
• Study Start: October 25, 2023
• Primary Completion: April 1, 2026
• Study Completion: May 1, 2026
• Last Updated: July 11, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)