Safety of Optimal PEEP in NSICU Patients
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|ClinicalTrials.gov Identifier: NCT03862027|
Recruitment Status : Terminated (Failure to enroll/recruit)
First Posted : March 5, 2019
Results First Posted : April 1, 2021
Last Update Posted : April 27, 2021
|Condition or disease||Intervention/treatment||Phase|
|Respiratory Failure Intracranial Hypertension||Device: Esophageal Balloon catheter||Not Applicable|
Purpose: To establish safety of titrating PEEP based on transpulmonary pressure as measured by an esophageal balloon in mechanically ventilated neurosurgical patients.
Participants: Adult patients admitted to the Neuro ICU at UNC Hospital and requiring mechanical ventilation who have an intracranial pressure monitoring device in place.
Procedures (methods): All enrolled patients will have esophageal balloons placed with measurement of transpulmonary pressures. All patients will have baseline measurements recorded of intracranial pressure, cerebral perfusion pressure, and cerebral autoregulation. PEEP will then be titrated based on transpulmonary pressure measurements with recording of physiological measurements over the next hour. At the conclusion of the hour, all patients will be returned to their prior ventilator settings.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Evaluating Safety of Transpulmonary Pressure Guided PEEP Management in Neurocritical Care Patients|
|Actual Study Start Date :||March 1, 2019|
|Actual Primary Completion Date :||March 4, 2019|
|Actual Study Completion Date :||March 4, 2019|
Experimental: Esophageal Balloon catheter
All patients will have an esophageal balloon catheter inserted into their nare while upright (head of bed > 30 degrees) to a depth slightly more than the estimated distance from the lower sternum to the back of the ear (typically around 60 cm). Gastric positioning will be confirmed with abdominal compression testing and the catheter then retracted 10 - 20 cm into the lower esophagus. Placement will be confirmed with the presence of cardiac oscillations on the esophageal probe. The probe will then be secured to the patient's nasal opening using tape.
Device: Esophageal Balloon catheter
Pressures [Esophageal Pressure (Pes), Airway Pressure (Paw), and Transpulmonary Pressure (Ptp)] are measured directly through the ventilator. The waveforms of Paw, Pes, and Ptp will be visualized on the ventilator. Ptp is obtained from Paw - Pes. All patients will have baseline measurements recorded of ICP, CPP, and MAP.
PEEP will be increased on the ventilator to achieve a Ptp between 0 and +2 cm H2O ("Optimal PEEP").
Measurements of Intracranial pressure (ICP), cerebral perfusion pressure (CPP), and mean arterial pressure (MAP) will be repeated 5 minutes after the change in PEEP.
- Change in ICP Value [ Time Frame: Within 5 minutes of catheter placement ]The Intracranial pressure (ICP) value after intervention will be considered equivalent to the ICP before intervention if the 95% upper bound of the change is lower than the non-inferiority margin of 4 mm Hg.
- Change in Cerebral Perfusion Pressure (CPP) [ Time Frame: Immediately before and 5 minutes after ventilator setting change ]Cerebral perfusion pressure is equal to the mean arterial pressure (MAP) minus the intracranial pressure (ICP). The initial CPP is calculated by measuring CPP immediately before changing ventilator settings. The post-intervention CPP is measured 5 minutes after ventilator setting change is made. The difference between the initial CPP and the post-intervention CPP reflects the change in CPP.
- Change in Mean Arterial Pressure [ Time Frame: Immediately before and 5 minutes after ventilator setting change ]Mean Arterial Pressure (MAP) is the average arterial pressure in one cardiac cycle measured through an arterial line.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03862027
|United States, North Carolina|
|University of North Carolina at Chapel Hill|
|Chapel Hill, North Carolina, United States, 27599|
|Principal Investigator:||Shannon Carson, MD||University of North Carolina, Chapel Hill|