Atemunterstützung und -behandlung für eine effiziente und kostengünstige Pflege (REST EEC)
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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, Vereinigte Staaten, 15224
- UPMC Children's Hospital of Pittsburgh
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- <2 years of age Bronchiolitis WOB Score >2
Exclusion Criteria:
- Immunocompromised
- Immunosuppressed
- Chronic lung disease
- Congenital heart disease with baseline cardiorespiratory manifestations
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: HHFNC + Clinical decision Support
Standardized HHFNC weaning coupled with clinical decision support consisting of electronic record embedded reminders to the clinical team to wean HHFNC |
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. Wean patient off oxygen and flow as oxygenation and work of breathing improves. |
|
Aktiver Komparator: HHFNC Weaning
Team does not receive clinical decision support reminders to wean the HHFNC |
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. Wean patient off oxygen and flow as oxygenation and work of breathing improves. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
HFNC duration
Zeitfenster: 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 |
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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Respiratory support free days
Zeitfenster: 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 |
From date the start of respiratory support until the first documented respiratory support free day, up to 30 days
|
|
Hospital length of stay
Zeitfenster: 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 |
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
Zeitfenster: 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 |
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
Zeitfenster: From date of ending HHFNC until first documented oral intake, assessed up to 30 days
|
Time from HHFNC and 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
Zeitfenster: Through study completion, an average of 1 week
|
The product of mean airway pressure and the fraction of inspired oxygen |
Through study completion, an average of 1 week
|
|
Cost of hospitalization
Zeitfenster: 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 |
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.
|
|
Mortality
Zeitfenster: From date of admission until death from any cause, assessed up to 90 days
|
Patient Death |
From date of admission until death from any cause, assessed up to 90 days
|
|
PICU length of stay
Zeitfenster: 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. |
From data of admission to PICU to discharge from the PICU or death from any cause, whichever came first, assessed up to 90 days.
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Christopher Horvat, MD, UPMC Children's Hospital of Pittsburgh
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Tatsächlich)
Primärer Abschluss (Tatsächlich)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- STUDY23010030
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Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
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