Supporto respiratorio e trattamento per un'assistenza efficiente ed economica (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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, Stati Uniti, 15224
- UPMC Children's Hospital of Pittsburgh
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- <2 years of age Bronchiolitis WOB Score >2
Exclusion Criteria:
- Immunocompromised
- Immunosuppressed
- Chronic lung disease
- Congenital heart disease with baseline cardiorespiratory manifestations
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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. |
|
Comparatore attivo: 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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
HFNC duration
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Respiratory support free days
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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
Lasso di tempo: 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.
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Christopher Horvat, MD, UPMC Children's Hospital of Pittsburgh
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Effettivo)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- STUDY23010030
Piano per i dati dei singoli partecipanti (IPD)
Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .