Lung Protective Ventilation for Brain Injury

(NEUROVENT Trial)

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Colin Grissom

Disqualifiers: Comfort care, Death, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 5 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new ventilator protocol for patients with acute brain injuries. It uses lower ventilator volumes while maintaining normal carbon dioxide levels in the blood, which helps prevent further lung injury and supports brain recovery. Known as Lung Protective Ventilation, the protocol is being tested to determine if it can improve patient outcomes by aligning with current care standards for brain injury patients on ventilators. Individuals with conditions such as stroke, traumatic brain injury, or brain swelling, who are on a ventilator in an emergency or ICU setting, may qualify to participate. As an unphased trial, this study allows patients to contribute to innovative care practices that could enhance recovery for future patients.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What prior data suggests that this ventilator protocol is safe for patients with acute brain injury?

Research has shown that lung protective ventilation is generally well-tolerated by patients with brain injuries. Studies have found that using lower tidal volumes, which means moving less air in and out of the lungs with each breath, links to a lower risk of death in the ICU. Patients receiving this type of ventilation are less likely to die in the ICU compared to those receiving higher amounts of air.

One study found that using low tidal volumes did not increase the risk of developing serious lung conditions like acute respiratory distress syndrome (ARDS) and did not affect the overall risk of death. This suggests that the treatment is relatively safe and does not harm the lungs.

Overall, evidence supports that lung protective ventilation is a safe method for patients with acute brain injury, as it helps maintain stable breathing without adding risks of severe side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Lung Protective Ventilation for brain injuries because it focuses on minimizing lung stress while maintaining normal levels of carbon dioxide, which is crucial for patients with brain injuries. Unlike standard ventilation methods that might not prioritize lung protection, this approach uses the lowest tidal volume possible, adjusted to the patient's weight, to prevent additional respiratory complications. By optimizing oxygenation and carefully managing the weaning process from ventilation, this technique aims to improve outcomes for patients with both traumatic and non-traumatic brain injuries, potentially paving the way for better recovery and fewer complications.

What evidence suggests that this protocol is effective for lung protection in brain injury?

Research has shown that lung-protective ventilation can improve recovery in patients with sudden brain injuries. In this trial, participants will receive lung-protective ventilation, which uses lower air volumes in the lungs to reduce the risk of death in the ICU compared to higher volumes. One study found that patients receiving lower air volumes had better survival rates. Another study demonstrated that this method was also beneficial during surgery for individuals with brain injuries. These findings suggest that lower air settings can benefit patients with sudden brain injuries on ventilators. ^{1 2 5 6 7}

Who Is on the Research Team?

Colin K Grissom, MD

Principal Investigator

Intermountain Health Care, Inc.

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

Group I: Lung Protective Ventilation Experimental Treatment 1 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.

Who Is Running the Clinical Trial?

Colin Grissom

Lead Sponsor

Trials

1

Recruited

730+

Citations

1. atsjournals.org atsjournals.org/doi/10.1164/rccm.202402-0375OC

Lung-Protective Mechanical Ventilation in Patients with ... Mortality was 28.9% and 15.1% (RR, 1.91; 95% CI, 1.06–3.42; P = 0.02), ventilator dependency was 42.3% and 27.9% (RR, 1.52; 95% CI, 1.01–2.28; P ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39288368/

A Multicenter Randomized Clinical Trial (PROLABI) In patients with acute brain injury without ARDS, a lung-protective ventilatory strategy, as compared with a conventional strategy, did not reduce mortality.

3. ccforum.biomedcentral.com ccforum.biomedcentral.com/articles/10.1186/s13054-023-04509-3

Mechanical ventilation in patients with acute brain injury Protective mechanical ventilation combining low Vt and moderate to high levels of PEEP was effective in improving outcomes during surgery [35]. ...

4. journal.chestnet.org journal.chestnet.org/article/S0012-3692(25)00829-3/fulltext

Low-Tidal-Volume Ventilation and Mortality in Patients With ... Results: Patients ventilated with low tidal volumes had a lower adjusted risk of ICU mortality compared with those ventilated with > 8 mL/kg ...

5. link.springer.com link.springer.com/article/10.1007/s11910-025-01462-2

Brain Protective Ventilation Strategies in Severe Acute ... This narrative review synthesizes ten key evidence-based principles for optimizing ventilatory management in patients with acute brain injury, ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11544364/

Does Lung Protective Ventilation Work in Acute Brain Injury? Mortality and ventilator dependence were higher in the protective ventilation group, whereas the incidence of ARDS was similar. Outcomes at 6 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4960952/

Lung-protective Ventilation in Patients with Brain Injury A total of 104 patients were enrolled in the present study, 87 (83.7%) of whom were identified with severe brain injury based on a Glasgow Coma Scale ≤8 points.