Clinical Decision Support for Mechanical Ventilation of Patients With ARDS
Implementation of Computerized Clinical Decision Support for Mechanical Ventilation of Patients With Acute Respiratory Distress Syndrome
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
A multidisciplinary team of implementation researchers and clinical effectiveness researchers has been assembled to adapt the Consolidated Framework for Implementation Research (CFIR) for this planning study. The team identified the baseline clinical care delivery for LTVV in patients with ARDS across Intermountain hospitals and identified the barriers and facilitators to this standard of care. This pilot implementation study will focus on a Pilot Solution aimed at achieving ideal clinical care delivery of LTVV for patients with ARDS.
Abbreviations for Mechanical Ventilation:
PEEP: positive end expiratory pressure FIO2: fraction of inspired oxygen CPAP: continuous positive airway pressure PS: pressure support VC: volume control VC+: hybrid mode for volume targeted ventilation on Puritan Bennett ventilators PRVC: pressure regulated volume control, hybrid mode for volume targeted ventilation on Draeger ventilators PF ratio: ratio of partial pressure of arterial oxygen (PaO2 mmHg) divided by the FIO2 expressed in liters
Studietype
Inschrijving (Verwacht)
Fase
- Niet toepasbaar
Contacten en locaties
Studiecontact
- Naam: Colin K Grissom, MD
- Telefoonnummer: 801-507-6554
- E-mail: colin.grissom@imail.org
Studie Locaties
-
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Utah
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Murray, Utah, Verenigde Staten, 84107
- Werving
- Intermountain Medical Center
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Contact:
- Valerie Aston
- Telefoonnummer: 801-507-4606
- E-mail: valerie.aston@imail.org
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Onderonderzoeker:
- Ithan Peltan, MD
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Onderonderzoeker:
- Samuel Brown, MD
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Onderonderzoeker:
- Lindsay Leither, DO
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Onderonderzoeker:
- Michael Lanspa, MD
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Onderonderzoeker:
- Joseph Bledsoe, MD
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Onderonderzoeker:
- Scott Stevens, MD
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Contact:
- Carlos Barbagelata
- Telefoonnummer: 801-507-4607
- E-mail: carlos.barbagelata@imail.org
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Onderonderzoeker:
- Lori Carpenter
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Onderonderzoeker:
- Andrew Knighton, PhD
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Onderonderzoeker:
- Scott Narus, MD
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Onderonderzoeker:
- Rajendu Srivastava, MD
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
Inclusion Criteria:
- Invasive mechanical ventilation
- PF ratio <255
- Bilateral infiltrates on chest radiograph (adjudicated by a co-investigator)
- Presence of ≥1 risk factor for ARDS as determined by review of the HER
Exclusion Criteria:
- Age <18 years
- Pulmonary capillary wedge pressure >18 mm Hg if a right heart catheter is present
- Prisoner
- Known to be pregnant
- Death <24 hours from initial intubation
- Placed comfort care <24 hours from initial intubation
- Mechanically ventilated for >7 days prior to meeting ARDS criteria
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Onderzoek naar gezondheidsdiensten
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: Patients with ARDS at three Intermountain tertiary hospitals
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Implementation of processes to improve compliance with low tidal volume ventilation in patients with ARDS using a computerized protocol
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
LTVV Compliance
Tijdsspanne: through study completion - 6 months
|
Defined as: % of time each patient is on a compliant tidal volume for the duration of mechanical ventilation. Measured as: VC, PRVC, or VC+ with volume set to 6.5 ml/kg or less for each patient (proportion of mechanically ventilated hours, excluding hours on appropriate CPAP/PS) |
through study completion - 6 months
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
PEEP FI02 Compliance (continuous variable)
Tijdsspanne: through study completion - 6 months
|
Defined as: % of time each patient is on a compliant FI02 and PEEP combination. Measured as: using recommended (per most recently run oxygenation protocol) PEEP-FIO2 combinations, (proportion of ventilated hours, excluding the first four hours of mechanical ventilation and excluding hours on appropriate CPAP/PS) |
through study completion - 6 months
|
|
Utilization of Ventilation Protocol (continuous)
Tijdsspanne: through study completion - 6 months
|
Defined as: % of time each patient is managed with the computerized ventilation protocol. Measured as: Running the computerized ventilation protocol whenever a ventilator check is performed and an arterial blood gas was done within the previous hour, excluding hours on appropriate CPAP/PS |
through study completion - 6 months
|
|
Utilization of Oxygenation Protocol (continuous)
Tijdsspanne: through study completion - 6 months
|
Defined as: % of time each patient is managed with the computerized oxygenation protocol. Measured as: Running the computerized oxygenation protocol at least every four hours when a ventilator check was performed, excluding hours on appropriate CPAP/PS |
through study completion - 6 months
|
|
LTVV Compliance >90% (binary)
Tijdsspanne: through study completion - 6 months
|
Defined as: meeting, or not meeting, the target LTVV compliance of >90% for each patient. Measured as: VC, PRVC, or VC+ with volume set to 6.5 ml/kg or less for 90% or more of mechanically ventilated hours, excluding hours on appropriate CPAP/PS |
through study completion - 6 months
|
|
PEEP FI02 Compliance >70% (binary)
Tijdsspanne: through study completion - 6 months
|
Defined as: meeting, or not meeting, the target PEEP FI02 compliance of >70% for each patient. Measured as: Using recommended (per most recently run oxygenation protocol) PEEP-FIO2 combinations for at least 70% of mechanically ventilated hours (excluding the first four hours of mechanical ventilation and excluding hours on appropriate CPAP/PS) |
through study completion - 6 months
|
|
Ventilator-Free Days (VFD) to Day 28
Tijdsspanne: through study completion - 6 months
|
through study completion - 6 months
|
|
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% of Patients who do not survive to day 28
Tijdsspanne: through study completion - 6 months
|
through study completion - 6 months
|
Medewerkers en onderzoekers
Publicaties en nuttige links
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 1050867
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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