Wspomaganie oddychania i leczenie dla wydajnej i ekonomicznej opieki (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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
-
-
Pennsylvania
-
Pittsburgh, Pennsylvania, Stany Zjednoczone, 15224
- UPMC Children's Hospital of Pittsburgh
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- <2 years of age Bronchiolitis WOB Score >2
Exclusion Criteria:
- Immunocompromised
- Immunosuppressed
- Chronic lung disease
- Congenital heart disease with baseline cardiorespiratory manifestations
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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. |
|
Aktywny 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. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
HFNC duration
Ramy czasowe: 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
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Respiratory support free days
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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
Ramy czasowe: 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.
|
Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Christopher Horvat, MD, UPMC Children's Hospital of Pittsburgh
Publikacje i pomocne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Szacowany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- STUDY23010030
Plan dla danych uczestnika indywidualnego (IPD)
Planujesz udostępniać dane poszczególnych uczestników (IPD)?
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .