Study of Airway Pressure Release Ventilation and Intracranial Pressure in Patients With Severe Traumatic Brain Injury

University of Maryland Baltimore (UMB)

Status: Terminated

Conditions: Traumatic Brain Injury; Injury, Brain, Traumatic

Treatments: Other: Low Tidal Volume Ventilation; Other: Airway Pressure Release Ventilation

Study type: Observational

Funder types: Other

Identifiers

NCT02507973

HP-00063355

Details and patient eligibility

About

The investigators will conduct an observational crossover study. The investigators aim to recruit 50 participants with severe Traumatic Brain Injury (TBI) requiring intracranial pressure (ICP) monitoring during their stay at the Neuro Trauma ICU at the R Adams Cowley Shock Trauma Center.

Overall, participants will be monitored, on average, for approximately 6-8 hours during the study period. The investigators do not anticipate the need for prolonged monitoring during the duration of their hospital stay or post hospital period.

Full description

Each participant at admission will initially receive a primary mode of mechanical ventilation as determined by the attending trauma intensivists. 12-18 hours after recruitment, continuous monitoring of participants' ICP and hemodynamic status will commence to collect participants' baseline data for 30 minutes.

Participants will then undergo low tidal volume mechanical ventilation (LOTV), serving as a control mode of ventilation, for 2 hours prior to switching back to the primary mode of ventilation for 30 minutes. Next, patients will be placed on Airway Pressure Release Ventilation (APRV) for 2 hours. While receiving APRV, participants Intracranial pressure and hemodynamic status will be continuously monitored and recorded for comparison and analysis. After 2 hours of APRV, patients will be switched back to their previous mode of ventilation and more data collected for another 30 minutes.

Enrollment: 8 patients

Sex: All

Ages: 14+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Intracranial Pressure Monitoring device present
• Mechanically Ventilated
• Clinically Stable as determined by the Critical Care attending

Exclusion criteria

• Age <14
• Prisoners
• Initial Mode of ventilation is APRV
• Provider's Judgement
• Pregnant

Trial design

8 participants in 2 patient groups

Airway Pressure Release Ventilation:APRV

Description:

Each participant will serve as his/her own control using our observational crossover study comparing the effects of Airway Pressure Release Ventilation and Low Tidal Volume Ventilation on patient intracranial pressure and hemodynamic values.

Treatment:

Other: Airway Pressure Release Ventilation

Low Tidal Volume Ventilation:LOTV

Description:

Each participant will serve as his/her own control using our observational crossover study comparing the effects of Airway Pressure Release Ventilation and LOTV on patient intracranial pressure and hemodynamic values.

Treatment:

Other: Low Tidal Volume Ventilation