Clinical Decision Support for Mechanical Ventilation of Patients With ARDS

Acute Respiratory Distress Syndrome Clinical Trial

Official title:

Implementation of Computerized Clinical Decision Support for Mechanical Ventilation of Patients With Acute Respiratory Distress Syndrome

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03984175
• Other study ID #: 1050867
• Status: Recruiting
• Phase: N/A
• Start date: July 8, 2018
• Est. completion date: December 23, 2022

Study information

• Verified date: August 2022
• Source: Intermountain Health Care, Inc.
• Contact: Colin K Grissom, MD
• Phone: 801-507-6554
• Email: colin.grissom[@]imail.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Description:

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 350
• Est. completion date: December 23, 2022
• Est. primary completion date: December 23, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Newborn
• Syndrome

Intervention

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

Locations

Country	Name	City	State
United States	Intermountain Medical Center	Murray	Utah

Sponsors (5)

Lead Sponsor	Collaborator
Intermountain Health Care, Inc.	Dixie Regional Hospital, McKay-Dee Hospital, National Institutes of Health (NIH), Utah Valley Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	PEEP FI02 Compliance (continuous variable)	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
Secondary	Utilization of Ventilation Protocol (continuous)	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
Secondary	Utilization of Oxygenation Protocol (continuous)	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
Secondary	LTVV Compliance >90% (binary)	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
Secondary	PEEP FI02 Compliance >70% (binary)	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
Secondary	Ventilator-Free Days (VFD) to Day 28		through study completion - 6 months
Secondary	% of Patients who do not survive to day 28		through study completion - 6 months