Respiratory Support and Treatment for Efficient and Cost-Effective Care

Bronchiolitis Clinical Trial

— REST EEC  

Official title:

Respiratory Support and Treatment for Efficient and Cost-Effective Care

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05909566
• Other study ID #: STUDY23010030
• Status: Recruiting
• Phase: N/A
• Start date: October 25, 2023
• Est. completion date: May 2026

Study information

• Verified date: March 2024
• Source: University of Pittsburgh
• Contact: Christopher Horvat, MD
• Phone: 4126925298
• Email: christopher.horvat[@]chp.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 198
• Est. completion date: May 2026
• Est. primary completion date: April 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 2 Years

Eligibility

Inclusion Criteria:

• <2 years of age Bronchiolitis WOB Score >2

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Bronchiolitis

Intervention

Other:
• Clinical Decision Support (CDS)
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.

Device:
• HHFNC Weaning
Wean patient off oxygen and flow as oxygenation and work of breathing improves.

Locations

Country	Name	City	State
United States	UPMC Children's Hospital of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Christopher Horvat	Beckwith Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Respiratory support free days	Days alive and free of intensive care unit-based respiratory	Days from start of respiratory support to respiratory support free day
Secondary	Hospital length of stay	Days admitted in hospital	Days from admission to discharge from hospital or death
Secondary	Organ support free days	Days alive and free of ICU-based respiratory or cardiovascular organ support	Days from admission to organ support free days
Secondary	Time to oral intake	Time from HHFNC and oral intake	Days from being off HFNC until oral intake
Secondary	Ostensible respiratory distress measured by a respiratory severity score	The product of mean airway pressure and the fraction of inspired oxygen	Through study completion, an average of 1 week
Secondary	Cost of hospitalization	Totality of expenses incurred by a hospital in providing its services and care	Days from admission to discharge from hospital or date of death, up to 90 days
Secondary	90-day cost of care	Total cost is your premium + deductible + out-of-pocket costs + any total resource use and unit price(s), by payer or consumer, for a healthcare service or group of healthcare services, associated with a specified patient population?, time period, and unit(s) of clinical accountability for 90 days	Days of care from admission to 90 days
Secondary	Mortality	Patient Death	Days from admission to death