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NCT Number: NCT05909566

Respiratory Support and Treatment for Efficient and Cost-Effective Care

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Conditions

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

Age range

Up to 2 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UPMC Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • <2 years of age Bronchiolitis WOB Score >2

Exclusion criteria

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

Treatment and study plan

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 Weaning

Device

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

Primary outcomes

  1. HFNC duration

    Time frame: 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

    Amount of time patient is on HFNC

Secondary outcomes

  1. Respiratory support free days

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

    Days alive and free of intensive care unit-based respiratory

  2. Hospital length of stay

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

    Days admitted in hospital

  3. Organ support free days

    Time frame: 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

    Days alive and free of ICU-based respiratory or cardiovascular organ support

  4. Time to oral intake

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

    Time from HHFNC and oral intake

  5. Ostensible respiratory distress measured by a respiratory severity score

    Time frame: Through study completion, an average of 1 week

    The product of mean airway pressure and the fraction of inspired oxygen

  6. Cost of hospitalization

    Time frame: Days 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

  7. Mortality

    Time frame: From date of admission until death from any cause, assessed up to 90 days

    Patient Death

  8. PICU length of stay

    Time frame: From 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.

Sponsors and collaborators

Lead sponsor

Christopher Horvat

Other

Collaborators

  • The Greg Beckwith Foundation

Registry information

Acronym: REST EEC

Important dates

Study start
2023
Primary completion
2026
Study completion
2026
First posted
Jun 18, 2023
Registry last updated
Jul 21, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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