Implementation of Lung Protective Ventilation in Patients With Acute Respiratory Failure

Acute Respiratory Distress Syndrome Clinical Trial

— IMPROVENT  

Official title:

Implementation of Lung Protective Ventilation in Patients With Acute Respiratory Failure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03225807
• Other study ID #: 1050159
• Status: Completed
• Start date: March 2016
• Est. completion date: December 1, 2022

Study information

• Verified date: March 2024
• Source: Intermountain Health Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8692
• Est. completion date: December 1, 2022
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Lung Injury
• Acute Respiratory Distress Syndrome
• ARDS
• Respiratory Distress Syndrome
• Respiratory Distress Syndrome, Acute
• Respiratory Distress Syndrome, Newborn
• Respiratory Insufficiency
• Severe Acute Respiratory Syndrome
• Shock Lung
• Syndrome

Locations

Country	Name	City	State
United States	Colin Grissom	Murray	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Intermountain Health Care, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Ventilator free days to day 28		28 days
Secondary	30 day mortality		30 days
Secondary	90 day mortality		90 days
Secondary	Hospital discharge disposition		30 days
Secondary	Hospital mortality		1 week
Secondary	Time to first ICU activity		24 hours