Skip to content

Implementation of Neuro Lung Protective Ventilation

Implementation of Neuro Lung Protective Ventilation in Patients With Acute Brain Injury

Status
Active, not recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03243539
Acronym
NEUROVENT
Enrollment
728
Registered
2017-08-09
Start date
2017-08-31
Completion date
2024-12-31
Last updated
2024-03-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Brain Injury, Traumatic Brain Injury, Intracerebral Hemorrhage, Stroke, Cerebral Edema, Anoxic Brain Injury

Keywords

lung protective ventilation

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.

Interventions

Neuro lung protective ventilation for patients with acute brain injury is designed to target a normal partial pressure of arterial carbon dioxide and decrease initial tidal volumes toward a target 6 ml/kg predicted body weight PBW (range 6 to 8 ml/kg PBW)

Sponsors

Colin Grissom
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Patient-Level Proportion of time on Mechanical Ventilation with a Tidal Volume <= 6.5 ml/kg PBWTime of initiation of mechanical ventilation to time of cessation of mechanical ventilation, an average of 5 days

Secondary

MeasureTime frameDescription
Average number of protocol deviations for all subjects (protocol compliance)Time of initiation of mechanical ventilation to time of cessation of mechanical ventilation, an average of 5 daysAverage of the number of instances in which the procedures specified in the protocol were not followed for each enrolled subject
Hospital Discharge DispositionDay of hospital discharge, an average of 10 days after admissionRoutine, skilled nursing facility, home health, other
Hospital, 28-Day, and 90-Day MortalityHospital admission through 90 days
Ventilator-free days to day 28Initiation of mechanical ventilation to day 28
Proportion of time with a target PaCO2 of 35 to 45 mm HgTime of initiation of mechanical ventilation to time of cessation of mechanical ventilation, an average of 5 days
Hospital, ICU Length of StayDay of admission to day of discharge, an average of 10 days
Health Care UtilizationDay of admission to day of discharge, an average of 10 daysNumber of procedures/surgeries while in the hospital and number of days of hospitalization
Quality of Life - up to 1 year after day of dischargeDay of admission until up to 1 year after day of dischargeMay include SF-36 or similar measures
Costs of CareDay of admission to day of discharge, an average of 10 days
Time to First ICU ActivityDay of admission to day of first ICU activity, an average of 0.2 days

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026