NCT03984175

Brief Summary

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).

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
350

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jul 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 8, 2018

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

June 3, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

June 12, 2019

Completed
3.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 23, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 23, 2022

Completed
Last Updated

August 3, 2022

Status Verified

August 1, 2022

Enrollment Period

4.5 years

First QC Date

June 3, 2019

Last Update Submit

August 1, 2022

Conditions

Acute Respiratory Distress Syndrome

Keywords

ARDSLung Protective Mechanical VentilationClinical Decision Support

Outcome Measures

Primary Outcomes (1)

  • LTVV Compliance

    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

Secondary Outcomes (7)

  • PEEP FI02 Compliance (continuous variable)

    through study completion - 6 months

  • Utilization of Ventilation Protocol (continuous)

    through study completion - 6 months

  • Utilization of Oxygenation Protocol (continuous)

    through study completion - 6 months

  • LTVV Compliance >90% (binary)

    through study completion - 6 months

  • PEEP FI02 Compliance >70% (binary)

    through study completion - 6 months

  • +2 more secondary outcomes

Study Arms (1)

Patients with ARDS at three Intermountain tertiary hospitals

EXPERIMENTAL
Procedure: Implementation of Processes

Interventions

Implementation of ProcessesPROCEDURE

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

Patients with ARDS at three Intermountain tertiary hospitals

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Intermountain Medical Center

Murray, Utah, 84107, United States

RECRUITING

Related Publications (1)

  • 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.

    PMID: 36350983DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration Disorders

Central Study Contacts

Colin K Grissom, MD

CONTACT

801-507-6554colin.grissom@imail.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
SINGLE GROUP
Model Details: Before and After Comparison
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 3, 2019

First Posted

June 12, 2019

Study Start

July 8, 2018

Primary Completion

December 23, 2022

Study Completion

December 23, 2022

Last Updated

August 3, 2022

Record last verified: 2022-08

Locations

US(1)