Clinical trial NCT03225807: Implementation of Lung Protective Ventilation in Patients With Acute Respiratory Failure
Official title: Implementation of Lung Protective Ventilation in Patients With Acute Respiratory Failure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Respiratory Distress Syndrome
ARDS
Respiratory Distress Syndrome, Acute
Respiratory Insufficiency
Respiratory Distress Syndrome
Shock Lung
Severe Acute Respiratory Syndrome
Keywords: Intubated
Intubation
Ventilator
Ventilator-free days
Ventilator free days
Mechanical Ventilation
Meta-Analysis
Tidal Volume
Tidal Volumes
inflammation
cytokines
Pulmonary Infiltrate
Pulmonary Infiltrates
Low Tidal Volumes
Protective Ventilation
Lead sponsor: Intermountain Health Care, Inc.
Sponsor class: OTHER
First posted: 2017-07-21
Enrollment: 8692
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patient Selection Those to be enrolled must have respiratory failure requiring intubation and initiation of mechanical ventilation. Patients will be divided into two different groups: those patients who are managed with the computerized lung protective ventilation protocol as ordered by the attending physician and those patients managed with physician specified mechanical ventilation settings.

Brief summary: This is a quality improvement study with the purpose of observing and measuring the effects of implementation of a proven standardized lung protective ventilation protocol in the new electronic medical record system iCentra across all Intermountain Healthcare hospitals. Approximately 14,000 records will be accessed for this study from a database of mechanically ventilated patients established for quality improvement purposes.

The investigators hypothesize that implementation of a standardized computerized lung protective ventilation protocol across all Intermountain Healthcare hospitals will be feasible, will decrease initial tidal volumes to the target 6 ml/kg PBW, and will improve outcomes.

The objectives of this study are to:

* Determine if the implementation of lung protective ventilation (with a 6 ml/kg PBW tidal volume ventilation protocol on initiation of mechanical ventilation) improves outcomes in patients with acute respiratory failure requiring mechanical ventilation
* Determine if the implementation of lung protective ventilation (with a 6 ml/kg PBW tidal volume ventilation protocol on initiation of mechanical ventilation) improves outcomes in the sub-group of patients with the acute respiratory distress syndrome (ARDS)
* Measure compliance with the implementation of a computerized lung protective ventilation protocol at 12 Intermountain Healthcare hospitals

Detailed description: Study Design:

This is an observational quality improvement study comparing outcomes before, and after, implementation of a proven lung protective ventilation protocol in an electronic medical record system, iCentra, that will be implemented in phases across Intermountain Healthcare hospitals. A phased implementation with a two-month washout period will be used to evaluate the primary outcome of interest, ventilator free days (VFDs) to 28 days. Secondary outcomes will include: use of the protocol by clinicians, compliance with protocol instructions, hospital discharge disposition, hospital, 30-day, and 90-day mortality, time to first ICU activity, hospital length of stay, ICU length of stay, heath care utilization, quality of life, and costs of care. As the iCentra electronic medical record is implemented at Intermountain Healthcare hospitals, clinicians will have the opportunity to use the computerized lung protective ventilation protocol, or to order mechanical ventilation settings independently. This is an observational study designed to measure how often the computerized lung protective ventilation protocol will be ordered, compliance with the instructions of the protocol, and clinical outcomes among patients who are managed with the protocol. Physicians may choose to use the protocol on intubated patients requiring mechanical ventilation or they may choose to order other specific mechanical ventilator settings.

Eligibility criteria: Inclusion Criteria

1. Initiation of mechanical ventilation in the emergency department or intensive care unit at an Intermountain Healthcare hospital
2. Age ≥ 18 years

Exclusion Criteria

1. Transition to comfort care in the emergency department or on the same day of admission to the ICU
2. Death on the same day of admission to the emergency department or ICU

Primary outcomes:
measure: Ventilator free days to day 28
timeFrame: 28 days
Secondary outcomes:
measure: 30 day mortality
timeFrame: 30 days
measure: 90 day mortality
timeFrame: 90 days
measure: Hospital discharge disposition
timeFrame: 30 days
measure: Hospital mortality
timeFrame: 1 week
measure: Time to first ICU activity
timeFrame: 24 hours
Other outcomes:
Locations:
city: Murray
country: United States
facility: Colin Grissom
state: Utah
Study officials:
affiliation: Intermountain Health Care, Inc.
name: Colin Grissom, MD
role: PRINCIPAL_INVESTIGATOR
References: