Implementation of Lung Protective Ventilation in Patients With Acute Respiratory Failure

NCT03225807 | Completed

• 1 other identifier: 1050159
• Study Type: observational
• Target: 8,692
• Locations: 1 country
• Sites: 1

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

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

Outcome Measures

Primary Outcomes (1)

• Ventilator free days to day 28

  28 days

Secondary Outcomes (5)

• 30 day mortality

  30 days

• 90 day mortality

  90 days

• Hospital discharge disposition

  30 days

• Hospital mortality

  1 week

• Time to first ICU activity

  24 hours

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Intermountain Health Care, Inc.: lead

Study Sites (1)

Colin Grissom

Murray, Utah, 84121, United States

Location

Related Publications (1)

• Grissom CK, Lanspa MJ, Groat D, Jacobs JR, Carpenter L, Kuttler KG, Leither L, Peltan ID, Brown SM, Srivastava R. Implementation of Lung-Protective Ventilation in Patients With Acute Respiratory Failure. Crit Care Med. 2023 Jun 1;51(6):797-807. doi: 10.1097/CCM.0000000000005840. Epub 2023 Mar 29.

  PMID: 36988337 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome; Respiratory Insufficiency; Severe Acute Respiratory Syndrome; Inflammation

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Respiratory Tract Infections; Infections; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Colin Grissom, MD

  Intermountain Health Care, Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 14, 2017
• First Posted: July 21, 2017
• Study Start: March 1, 2016
• Primary Completion: December 1, 2022
• Study Completion: December 1, 2022
• Last Updated: March 12, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)