Clinical Decision Support for Mechanical Ventilation of Patients With ARDS

NCT ID: NCT03984175

Last Updated: 2022-08-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

350 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-07-08

Study Completion Date

2022-12-23

Brief Summary

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Perform a pilot study of quality improvement interventions for critical care physicians (intensivists) and respiratory therapists (RTs) to improve application of low tidal volume mechanical ventilation (LTVV) for patients with the acute respiratory distress syndrome (ARDS) using the computerized mechanical ventilation protocols currently available in the investigator's Cerner electronic health record (EHR).

Detailed Description

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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

Conditions

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Acute Respiratory Distress Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Before and After Comparison
Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

NONE

Study Groups

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Patients with ARDS at three Intermountain tertiary hospitals

Group Type EXPERIMENTAL

Implementation of Processes

Intervention Type PROCEDURE

Implementation of processes to improve compliance with low tidal volume ventilation in patients with ARDS using a computerized protocol

Interventions

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Implementation of Processes

Implementation of processes to improve compliance with low tidal volume ventilation in patients with ARDS using a computerized protocol

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

1. Invasive mechanical ventilation
2. PF ratio \<255
3. Bilateral infiltrates on chest radiograph (adjudicated by a co-investigator)
4. Presence of ≥1 risk factor for ARDS as determined by review of the HER

Exclusion Criteria

1. Age \<18 years
2. Pulmonary capillary wedge pressure \>18 mm Hg if a right heart catheter is present
3. Prisoner
4. Known to be pregnant
5. Death \<24 hours from initial intubation
6. Placed comfort care \<24 hours from initial intubation
7. Mechanically ventilated for \>7 days prior to meeting ARDS criteria
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Institutes of Health (NIH)

NIH

Sponsor Role collaborator

McKay-Dee Hospital

OTHER

Sponsor Role collaborator

Utah Valley Hospital

UNKNOWN

Sponsor Role collaborator

Dixie Regional Hospital

UNKNOWN

Sponsor Role collaborator

Intermountain Health Care, Inc.

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Intermountain Medical Center

Murray, Utah, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Colin K Grissom, MD

Role: CONTACT

801-507-6554

Facility Contacts

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Valerie Aston

Role: primary

801-507-4606

Carlos Barbagelata

Role: backup

801-507-4607

References

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Peltan ID, Knighton AJ, Barney BJ, Wolfe D, Jacobs JR, Klippel C, Allen L, Lanspa MJ, Leither LM, Brown SM, Srivastava R, Grissom CK. Delivery of Lung-protective Ventilation for Acute Respiratory Distress Syndrome: A Hybrid Implementation-Effectiveness Trial. Ann Am Thorac Soc. 2023 Mar;20(3):424-432. doi: 10.1513/AnnalsATS.202207-626OC.

Reference Type DERIVED
PMID: 36350983 (View on PubMed)

Other Identifiers

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1050867

Identifier Type: -

Identifier Source: org_study_id

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