Implementation of Neuro Lung Protective Ventilation

Stroke Clinical Trial

— NEUROVENT  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03243539
• Other study ID #: 1050582
• Status: Active, not recruiting
• Phase: N/A
• Start date: August 31, 2017
• Est. completion date: December 31, 2024

Study information

• Verified date: March 2024
• Source: Intermountain Health Care, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 728
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Brain Injury
• Anoxic Brain Injury
• Brain Edema
• Brain Injuries
• Brain Injuries, Traumatic
• Cerebral Edema
• Cerebral Hemorrhage
• Hemorrhage
• Intracerebral Hemorrhage
• Stroke
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

Procedure:
• Lung Protective Ventilation
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)

Locations

Country	Name	City	State
United States	Intermountain Medical Center	Murray	Utah

Sponsors (1)

Lead Sponsor	Collaborator
Colin Grissom

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	Hospital Discharge Disposition	Routine, skilled nursing facility, home health, other	Day of hospital discharge, an average of 10 days after admission
Secondary	Hospital, 28-Day, and 90-Day Mortality		Hospital admission through 90 days
Secondary	Ventilator-free days to day 28		Initiation of mechanical ventilation to day 28
Secondary	Time to First ICU Activity		Day of admission to day of first ICU activity, an average of 0.2 days
Secondary	Hospital, ICU Length of Stay		Day of admission to day of discharge, an average of 10 days
Secondary	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
Secondary	Quality of Life - up to 1 year after day of discharge	May include SF-36 or similar measures	Day of admission until up to 1 year after day of discharge
Secondary	Costs of Care		Day of admission to day of discharge, an average of 10 days