Clinical trial NCT03243539: Implementation of Neuro Lung Protective Ventilation
Official title: Implementation of Neuro Lung Protective Ventilation in Patients With Acute Brain Injury
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Acute Brain Injury
Traumatic Brain Injury
Intracerebral Hemorrhage
Stroke
Cerebral Edema
Anoxic Brain Injury
Keywords: lung protective ventilation
Lead sponsor: Intermountain Health Care, Inc.
Sponsor class: OTHER
First posted: 2017-08-09
Enrollment: 728
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Patients who experience lung injury are often placed on a ventilator to help them heal; however, if the ventilator volume settings are too high, it can cause additional lung injury. It is proven that using lower ventilator volume settings improves outcomes. In patients with acute brain injury, it is proven that maintaining a normal partial pressure of carbon dioxide in the arterial blood improves outcomes. Mechanical ventilator settings with higher volumes and higher breathing rates are sometimes required to maintain a normal partial pressure of carbon dioxide. These 2 goals of mechanical ventilation, using lower volumes to prevent additional lung injury but maintaining a normal partial pressure of carbon dioxide, are both important for patients with acute brain injury. The investigators have designed a computerized ventilator protocol in iCentra that matches the current standard of care for mechanical ventilation of patients with acute brain injury by targeting a normal partial pressure of carbon dioxide with the lowest ventilator volume required.

This is a quality improvement study with the purpose of observing and measuring the effects of implementation of a standard of care mechanical ventilation protocol for patients with acute brain injury in the iCentra electronic medical record system at Intermountain Medical Center. We hypothesize that implementation of a standardized neuro lung protective ventilation protocol will be feasible, will achieve a target normal partial pressure of carbon dioxide, will decrease tidal volumes toward the target 6 mL/kg predicted body weight, and will improve outcomes.


Eligibility criteria: Inclusion Criteria:

1. Acute brain injury due to non-traumatic causes (stroke, spontaneous intracranial hemorrhage, cerebral edema, anoxic brain injury) or traumatic brain injury.
2. Initiation of mechanical ventilation in the emergency department or intensive care unit at an Intermountain Healthcare hospital
3. 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: Patient-Level Proportion of time on Mechanical Ventilation with a Tidal Volume <= 6.5 ml/kg PBW
timeFrame: Time of initiation of mechanical ventilation to time of cessation of mechanical ventilation, an average of 5 days
Secondary outcomes:
measure: Proportion of time with a target PaCO2 of 35 to 45 mm Hg
timeFrame: Time of initiation of mechanical ventilation to time of cessation of mechanical ventilation, an average of 5 days
measure: Average number of protocol deviations for all subjects (protocol compliance)
timeFrame: Time of initiation of mechanical ventilation to time of cessation of mechanical ventilation, an average of 5 days
measure: Hospital Discharge Disposition
timeFrame: Day of hospital discharge, an average of 10 days after admission
measure: Hospital, 28-Day, and 90-Day Mortality
timeFrame: Hospital admission through 90 days
measure: Ventilator-free days to day 28
timeFrame: Initiation of mechanical ventilation to day 28
measure: Time to First ICU Activity
timeFrame: Day of admission to day of first ICU activity, an average of 0.2 days
measure: Hospital, ICU Length of Stay
timeFrame: Day of admission to day of discharge, an average of 10 days
measure: Health Care Utilization
timeFrame: Day of admission to day of discharge, an average of 10 days
measure: Quality of Life - up to 1 year after day of discharge
timeFrame: Day of admission until up to 1 year after day of discharge
measure: Costs of Care
timeFrame: Day of admission to day of discharge, an average of 10 days
Other outcomes:
Locations:
city: Murray
country: United States
facility: Intermountain Medical Center
state: Utah
Study officials:
affiliation: Intermountain Health Care, Inc.
name: Colin K Grissom, MD
role: PRINCIPAL_INVESTIGATOR
References: