728 Participants Needed

Lung Protective Ventilation for Brain Injury

(NEUROVENT Trial)

Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Colin Grissom
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

What is the purpose of this trial?

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.

Research Team

CK

Colin K Grissom, MD

Principal Investigator

Intermountain Health Care, Inc.

Eligibility Criteria

This trial is for adults (18+) with acute brain injury, either from non-traumatic causes like stroke or anoxic brain injury, or from traumatic events. They must be starting mechanical ventilation in the emergency department or ICU at an Intermountain Healthcare hospital.

Inclusion Criteria

I have a brain injury from a stroke, bleeding in the brain, swelling, or lack of oxygen.
I started using a breathing machine in the ICU or emergency at an Intermountain Healthcare hospital.

Exclusion Criteria

Death on the same day of admission to the emergency department or ICU
I was moved to comfort care the same day I was admitted to the ICU or ER.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Implementation of neuro lung protective ventilation protocol targeting normal arterial partial pressure of carbon dioxide with the lowest tidal volume possible

5 days
Continuous monitoring during hospital stay

Follow-up

Participants are monitored for quality of life and health care utilization after discharge

Up to 1 year

Treatment Details

Interventions

  • Lung Protective Ventilation
Trial Overview The study tests a computerized ventilator protocol aiming to maintain normal carbon dioxide levels in blood while using the lowest necessary ventilator volume. It's designed to prevent further lung damage and improve outcomes for patients with acute brain injuries.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: Lung Protective VentilationExperimental Treatment1 Intervention
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.

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Who Is Running the Clinical Trial?

Colin Grissom

Lead Sponsor

Trials
1
Recruited
730+
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