An interventional study of PEEP Titrated Mechanical Ventilation in Intracranial Pressure, Mechanical Ventilation and Brain Injuries, sponsored by Beth Israel Deaconess Medical Center. Withdrawn. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-01-27.
Sponsored by Beth Israel Deaconess Medical Center · Not applicable, Interventional, and Other
The purpose of this study is to understand the relationship between intracranial pressure and airway pressures during mechanical ventilation. This study is a single-center, prospective cohort study to be conducted at Beth Israel Deaconess Medical Center. The investigators will recruit patients with severe brain injury (GCS 8 or less) who receive intracranial pressure monitoring and mechanical ventilation as part of their routine medical care. The primary endpoint is the change in intracranial pressure as a function of positive end-expiratory pressure. There is only one study encounter with safety monitoring for up to 24 hours after. No additional follow up is required.
2,112 studies on the registry are indexed under Brain Injuries; 384 are open to participants now.
Browse Brain Injuries studies →Beth Israel Deaconess Medical Center is the lead sponsor of 560 studies on the registry; 80 are open to participants now.
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Exclusion Criteria:
Cessation Criteria: Study related ventilator adjustments and measurements will be stopped at any point during the intervention and ventilator settings will be returned to the pre-intervention settings under the following conditions:
Other: PEEP Titrated Mechanical Ventilation
Subjects will receive a sequential, step-wise increase in positive end-expired pressure from 5 cmH2O to 15 cmH2O and back down to 5 cmH20. Pleural pressure and intracranial pressure will be measured at each increment. PEEP will be increased by increments of 5 cmH2O. The physiologic measurements will be obtained at regular intervals (within 5 minutes at each PEEP level) throughout the PEEP titration period. The mode of mechanical ventilation (pressure or volume control), inspiratory time and fraction of inspired oxygen (FIO2) will be determined by the critical care team caring for the patient. In the event that PEEP is set \> 5 cmH2O, measurements will be obtained from that starting point and increased to a maximum of 15 cmH2O. At the completion of the study patients will be returned to the PEEP level they were on prior to titration of the ventilator.
Change in intracranial pressure
The primary endpoint is the change in intracranial pressure as a function of positive end-expiratory pressure.
Time frame: Change from baseline to 20 minutes
No study locations are listed for this record.
Plan to share: No
This study is withdrawn, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Beth Israel Deaconess Medical Center