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Respiratory Support and Treatment for Efficient and Cost-Effective Care

Respiratory Support and Treatment for Efficient and Cost-Effective Care

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05909566
Acronym
REST EEC
Enrollment
362
Registered
2023-06-18
Start date
2023-10-25
Completion date
2026-08-01
Last updated
2026-07-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bronchiolitis

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.

Interventions

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.

DEVICEHHFNC Weaning

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

Sponsors

Christopher Horvat
Lead SponsorOTHER
The Greg Beckwith Foundation
CollaboratorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
No minimum to 2 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
HFNC durationTimeframe 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 daysAmount of time patient is on HFNC

Secondary

MeasureTime frameDescription
Respiratory support free daysFrom date the start of respiratory support until the first documented respiratory support free day, up to 30 daysDays alive and free of intensive care unit-based respiratory
Hospital length of stayFrom date of admission until discharge or date of death from any cause, whichever came first, assessed up to 90 days.Days admitted in hospital
Organ support free daysFrom 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 daysDays alive and free of ICU-based respiratory or cardiovascular organ support
Time to oral intakeFrom date of ending HHFNC until first documented oral intake, assessed up to 30 daysTime from HHFNC and oral intake
Ostensible respiratory distress measured by a respiratory severity scoreThrough study completion, an average of 1 weekThe product of mean airway pressure and the fraction of inspired oxygen
Cost of hospitalizationDays from admission to discharge from hospital or date of death, up to 90 days. Of note, an earlier outcome was listed for 90-day cost of care and the redundancy with this outcome was recognized, so the 90-day cost of care outcome was removed.Totality of expenses incurred by a hospital in providing its services and care
MortalityFrom date of admission until death from any cause, assessed up to 90 daysPatient Death
PICU length of stayFrom data of admission to PICU to discharge from the PICU or death from any cause, whichever came first, assessed up to 90 days.Days admitted in the PICU. This is added to reconcile the plan to evaluate this outcome and its noted absence from this website, as pointed out by a reviewer while working to publish the trial design.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORChristopher Horvat, MD

UPMC Children's Hospital of Pittsburgh

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Jul 22, 2026