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OpenTrials
Completed

NCT Number: NCT03225807

Implementation of Lung Protective Ventilation in Patients With Acute Respiratory Failure

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Primary outcomes

  1. Ventilator free days to day 28

    Time frame: 28 days

Secondary outcomes

  1. 30 day mortality

    Time frame: 30 days

  2. 90 day mortality

    Time frame: 90 days

  3. Hospital discharge disposition

    Time frame: 30 days

  4. Hospital mortality

    Time frame: 1 week

  5. Time to first ICU activity

    Time frame: 24 hours

Sponsors and collaborators

Lead sponsor

Intermountain Health Care, Inc.

Other

Registry information

Acronym: IMPROVENT

Important dates

Study start
2016
Primary completion
2022
Study completion
2022
First posted
Jul 21, 2017
Registry last updated
Mar 12, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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