Trial Outcomes & Findings for Study of Airway Pressure Release Ventilation and Intracranial Pressure in Patients With Severe Traumatic Brain Injury (NCT NCT02507973)

NCT ID: NCT02507973

Last Updated: 2022-01-28

Results Overview

We aim to evaluate the patients during the two modes of ventilation (LTOV and APRV) to determine if there are significant differences in their ICP based on ventilation mode.

• Recruitment status: TERMINATED
• Target enrollment: 8 participants
• Primary outcome timeframe: On average, 24 hours for each patient
• Results posted on: 2022-01-28

Participant Flow

200 patients were screened for eligibility between July 2015 and April 2018 at University of Maryland, Baltimore.

8 of 200 patients were randomized. The other patients were excluded as they did not meet the eligibility criteria.

Participant milestones

Measure	LOTV, Then APRV Participants first were maintained on Low Tidal Volume Ventilation for two hours. Then there was a washout period of 30 minutes. After this washout period, they were maintained on Airway Pressure Release Ventilation for two hours. 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. Airway Pressure Release Ventilation: Airway pressure release ventilation (APRV) is a mode of mechanical ventilation that switches between high (PHigh) and low (PLow) continuous positive airway pressure while allowing spontaneous breathing at both phases. Alveolar recruitment and oxygenation occur during PHigh whereas ventilation occurs during brief releases to PLow.
Overall Study STARTED	8
Overall Study COMPLETED	7
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure

LOTV, Then APRV Participants first were maintained on Low Tidal Volume Ventilation for two hours. Then there was a washout period of 30 minutes. After this washout period, they were maintained on Airway Pressure Release Ventilation for two hours. 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. Airway Pressure Release Ventilation: Airway pressure release ventilation (APRV) is a mode of mechanical ventilation that switches between high (PHigh) and low (PLow) continuous positive airway pressure while allowing spontaneous breathing at both phases. Alveolar recruitment and oxygenation occur during PHigh whereas ventilation occurs during brief releases to PLow.

Overall Study Adverse Event

1

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	LOTV Then APRV n=8 Participants Participants first were maintained on Low Tidal Volume Ventilation for two hours. Then there was a washout period of 30 minutes. After this washout period, they were maintained on Airway Pressure Release Ventilation for two hours. 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. Airway Pressure Release Ventilation: Airway pressure release ventilation (APRV) is a mode of mechanical ventilation that switches between high (PHigh) and low (PLow) continuous positive airway pressure while allowing spontaneous breathing at both phases. Alveolar recruitment and oxygenation occur during PHigh whereas ventilation occurs during brief releases to PLow.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	8 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Patients Not Initially on APRV	8 Participants n=5 Participants

PRIMARY outcome

Timeframe: On average, 24 hours for each patient

Population: Access to original intracranial pressure data lost and cannot be summarized No data was analyzed to report.

We aim to evaluate the patients during the two modes of ventilation (LTOV and APRV) to determine if there are significant differences in their ICP based on ventilation mode.

Outcome measures

Outcome data not reported

Adverse Events

LOTV

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

APRV

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	LOTV n=8 participants at risk All Participants first were maintained on Low Tidal Volume Ventilation for two hours. Then there was a washout period of 30 minutes. After this washout period, they were maintained on Airway Pressure Release Ventilation for two hours. 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. Airway Pressure Release Ventilation: Airway pressure release ventilation (APRV) is a mode of mechanical ventilation that switches between high (PHigh) and low (PLow) continuous positive airway pressure while allowing spontaneous breathing at both phases. Alveolar recruitment and oxygenation occur during PHigh whereas ventilation occurs during brief releases to PLow. Patient's volume statuses and cardiac functions were assessed during the study period No data was analyzed to report.	APRV n=8 participants at risk All Participants first were maintained on Low Tidal Volume Ventilation for two hours. Then there was a washout period of 30 minutes. After this washout period, they were maintained on Airway Pressure Release Ventilation for two hours. 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. Airway Pressure Release Ventilation: Airway pressure release ventilation (APRV) is a mode of mechanical ventilation that switches between high (PHigh) and low (PLow) continuous positive airway pressure while allowing spontaneous breathing at both phases. Alveolar recruitment and oxygenation occur during PHigh whereas ventilation occurs during brief releases to PLow. Patient's volume statuses and cardiac functions were assessed during the study period No data was analyzed to report.
Blood and lymphatic system disorders Increased systolic blood pressure	12.5% 1/8 • Number of events 1 • 1 day	12.5% 1/8 • Number of events 1 • 1 day

Other adverse events

Adverse event data not reported

Additional Information

Dr Deborah Stein

The R Adams Cowley Shock Trauma Center

Phone: 410-328-3495

Email: dstein@umm.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place