Ignite Creation Date:
2024-05-06 @ 7:17 AM
Last Modification Date:
2024-10-26 @ 11:47 AM
Study NCT ID:
NCT02507973
Status:
TERMINATED
Last Update Posted:
2022-01-28
First Post:
2015-07-17
Brief Title:
Study of Airway Pressure Release Ventilation and Intracranial Pressure in Patients With Severe Traumatic Brain Injury
Sponsor:
University of Maryland Baltimore
Organization:
University of Maryland Baltimore
Study Overview
Official Title:
Study of APRV and ICP in Patients With Severe Traumatic Brain Injury
Status:
TERMINATED
Status Verified Date:
2022-01
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Unable to successfully recruit patients for study
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
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
Detailed 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None