Real-Time Decision Support for Improving Intraoperative Cerebral Perfusion Pressure

NCT03285971 | Completed Early Phase 1 FDA Drug

• 1 other identifier: HUM117828
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

Brief Summary

Across broad surgical populations, cerebral hypoperfusion is associated with increased mortality, stroke, brain cellular injury, and poor functional outcomes. Based on available evidence, The Brain Trauma Foundation recommends that cerebral perfusion pressure (CPP) be maintained greater than 60 mmHg in high-risk settings to minimize risk of cerebral ischemia. Though several lines of investigation have focused on optimal cerebrovascular management in the intensive care unit and cardiac surgery settings, much less focus has been placed on cerebrovascular management during non-cardiac surgery. Preliminary data indicate that intraoperative CPP routinely falls below 60 mmHg in neurosurgical and trauma surgery settings, though the relationship between reduced intraoperative CPP and outcomes remains unclear. Furthermore, effective methods by which low intraoperative CPP could be prevented have not been thoroughly investigated, which represents the first required step prior to studying the relationship between intraoperative CPP and clinical outcomes. Thus, the aim of this study is to evaluate the efficacy of an automated algorithm that alerts clinicians to a decrease in CPP below 60 mmHg. This study tests the hypothesis that an automated pager alert system (triggered by CPP falling below 60 mmHg) will increase intraoperative CPP compared to standard of care.

Conditions

Cerebral Hypoperfusion

Outcome Measures

Primary Outcomes (1)

• Mean Cerebral Perfusion Pressure (CPP, mmHg)

  Assessed intraoperatively for the duration of the CPP monitoring period

Secondary Outcomes (7)

• Mortality (incidence, %)

  Within 30 days of surgery

• Postoperative Stroke (incidence, %)

  Within 30 days of surgery

• Myocardial Infarction (incidence, %)

  Within 30 days of surgery

• Congestive Heart Failure (incidence, %)

  Within 30 days of surgery

• Cardiac Dysrythmias (incidence, %)

  Within 30 days of surgery

Other Outcomes (3)

• Area Under the Curve (AUC) 60 mmHg (min*mmHg)

  Assessed intraoperatively for the duration of the CPP monitoring period

• Time Spent with CPP <60 mmHg

  Assessed intraoperatively for the duration of the CPP monitoring period

• Volume of Cerebrospinal Fluid (CSF) Drained Intraoperatively (mL)

  Assessed intraoperatively for the duration of the CPP monitoring period

Study Arms (2)

CPP Alert Group

EXPERIMENTAL

Device: Electronic CPP pager alert anesthesia providers will receive a pager alert when CPP decreases below 60 mmHg (median value over 5-minute epochs)

Other: Electronic CPP pager alert

Control

NO INTERVENTION

This arm will not receive the automated pager alerts.

Interventions

Electronic CPP pager alert OTHER

Anesthesia providers will receive a pager alert when CPP decreases beow 60 mmHG (median value over 5-minute epochs)

Also known as: Alerting system

CPP Alert Group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult (≥18 years old) surgical patients
• Intracranial pathology requiring intracranial pressure (ICP) monitoring

You may not qualify if:

• Intracranial aneurysm surgery
• Cases with pressures monitored from a lumbar drain
• Cardiac surgery cases
• Enrolled in conflicting study
• Pregnancy

Sponsors & Collaborators

• University of Michigan: lead

Study Sites (1)

Michigan Medicine - University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (5)

• Brain Trauma Foundation; American Association of Neurological Surgeons; Congress of Neurological Surgeons; Joint Section on Neurotrauma and Critical Care, AANS/CNS; Bratton SL, Chestnut RM, Ghajar J, McConnell Hammond FF, Harris OA, Hartl R, Manley GT, Nemecek A, Newell DW, Rosenthal G, Schouten J, Shutter L, Timmons SD, Ullman JS, Videtta W, Wilberger JE, Wright DW. Guidelines for the management of severe traumatic brain injury. IX. Cerebral perfusion thresholds. J Neurotrauma. 2007;24 Suppl 1:S59-64. doi: 10.1089/neu.2007.9987. No abstract available.

  PMID: 17511547 BACKGROUND

• Moore LE, Sharifpour M, Shanks A, Kheterpal S, Tremper KK, Mashour GA. Cerebral perfusion pressure below 60 mm Hg is common in the intraoperative setting. J Neurosurg Anesthesiol. 2012 Jan;24(1):58-62. doi: 10.1097/ANA.0b013e31822b4f05.

  PMID: 21862931 BACKGROUND

• Mashour GA, Tremper KK, Avidan MS. Protocol for the "Michigan Awareness Control Study": A prospective, randomized, controlled trial comparing electronic alerts based on bispectral index monitoring or minimum alveolar concentration for the prevention of intraoperative awareness. BMC Anesthesiol. 2009 Nov 5;9:7. doi: 10.1186/1471-2253-9-7.

  PMID: 19891771 BACKGROUND

• Mashour GA, Shanks A, Tremper KK, Kheterpal S, Turner CR, Ramachandran SK, Picton P, Schueller C, Morris M, Vandervest JC, Lin N, Avidan MS. Prevention of intraoperative awareness with explicit recall in an unselected surgical population: a randomized comparative effectiveness trial. Anesthesiology. 2012 Oct;117(4):717-25. doi: 10.1097/ALN.0b013e31826904a6.

  PMID: 22990178 BACKGROUND

• Blum JM, Stentz MJ, Maile MD, Jewell E, Raghavendran K, Engoren M, Ehrenfeld JM. Automated alerting and recommendations for the management of patients with preexisting hypoxia and potential acute lung injury: a pilot study. Anesthesiology. 2013 Aug;119(2):295-302. doi: 10.1097/ALN.0b013e3182987af4.

  PMID: 23681144 BACKGROUND

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Anesthesiology

Study Record Dates

• First Submitted: September 14, 2017
• First Posted: September 18, 2017
• Study Start: September 25, 2017
• Primary Completion: December 11, 2021
• Study Completion: December 11, 2021
• Last Updated: October 12, 2022

Record last verified: 2022-10

Locations

US (1)