Implementation of Neuro Lung Protective Ventilation

Study Overview
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Brief Summary
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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.

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

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

Intervention / Treatment
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* Procedure: Lung Protective Ventilation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute brain injury due to non-traumatic causes (stroke, spontaneous intracranial hemorrhage, cerebral edema, anoxic brain injury) or traumatic brain injury. 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lung Protective Ventilation<br>Subjects with acute brain injury (traumatic brain injury and non-traumatic brain injury) will receive neuro lung protective ventilation which targets a normal arterial partial pressure of carbon dioxide with the lowest tidal volume possible (6 to 8 ml/kg predicted body weight). Protocols for oxygenation and weaning from the ventilator will also be followed. | Procedure: Lung Protective Ventilation<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-Level Proportion of time on Mechanical Ventilation with a Tidal Volume <= 6.5 ml/kg PBW |  | Time of initiation of mechanical ventilation to time of cessation of mechanical ventilation, an average of 5 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of time with a target PaCO2 of 35 to 45 mm Hg |  | Time of initiation of mechanical ventilation to time of cessation of mechanical ventilation, an average of 5 days | 
| Average number of protocol deviations for all subjects (protocol compliance) | Average of the number of instances in which the procedures specified in the protocol were not followed for each enrolled subject | Time of initiation of mechanical ventilation to time of cessation of mechanical ventilation, an average of 5 days | 
| Hospital Discharge Disposition | Routine, skilled nursing facility, home health, other | Day of hospital discharge, an average of 10 days after admission | 
| Hospital, 28-Day, and 90-Day Mortality |  | Hospital admission through 90 days | 
| Ventilator-free days to day 28 |  | Initiation of mechanical ventilation to day 28 | 
| Time to First ICU Activity |  | Day of admission to day of first ICU activity, an average of 0.2 days | 
| Hospital, ICU Length of Stay |  | Day of admission to day of discharge, an average of 10 days | 
| Health Care Utilization | Number of procedures/surgeries while in the hospital and number of days of hospitalization | Day of admission to day of discharge, an average of 10 days | 
| Quality of Life | May include SF-36 or similar measures | Day of admission until up to 1 year after day of discharge | 
| Costs of Care |  | Day of admission to day of discharge, an average of 10 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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lung protective ventilation