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

NCT02507973 | Terminated Results

• 1 other identifier: HP-00063355
• Study Type: observational
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Injury, Brain, Traumatic; Traumatic Brain Injury

Keywords

Mechanical Ventilation; Intracranial Pressure; Airway Pressure Release Ventilation

Outcome Measures

Primary Outcomes (1)

• Intracranial Pressure

  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.

  On average, 24 hours for each patient

Study Arms (2)

Airway Pressure Release Ventilation:APRV

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.

Other: Airway Pressure Release Ventilation

Low Tidal Volume Ventilation:LOTV

Each participant will serve as his/her own control using our observational crossover study comparing the effects of Airway Pressure Release Ventilation and LOTV on patient intracranial pressure and hemodynamic values.

Other: Low Tidal Volume Ventilation

Interventions

Airway Pressure Release Ventilation OTHER

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.

Also known as: APRV

Airway Pressure Release Ventilation:APRV

Low Tidal Volume Ventilation OTHER

After enrollment and collection of baseline Intracranial pressure and hemodynamic status for 30 minutes the participants will undergo low tidal volume mechanical ventilation (LOTV), serving as a control mode of ventilation. LOTV is most commonly used for trauma patients with lung injury. LOTV provides oxygen in smaller amounts, without overstretching the lungs

Also known as: LOTV

Low Tidal Volume Ventilation:LOTV

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All patients with intracranial pressure monitor requiring mechanical ventilation support will be eligible for enrollment in the study

You may qualify if:

• Intracranial Pressure Monitoring device present
• Mechanically Ventilated
• Clinically Stable as determined by the Critical Care attending

You may not qualify if:

• Age \<14
• Prisoners
• Initial Mode of ventilation is APRV
• Provider's Judgement
• Pregnant

Sponsors & Collaborators

• University of Maryland, Baltimore: lead

Study Sites (1)

RA Cowley Shock Trauma Center

Baltimore, Maryland, 21201, United States

Location

Related Publications (22)

• Bosio A. A theoretical study of new types of valve shunts for cerebrospinal fluid. ASAIO Trans. 1991 Jul-Sep;37(3):M289-90.

  PMID: 1751154 BACKGROUND

• Chesnut RM, Marshall SB, Piek J, Blunt BA, Klauber MR, Marshall LF. Early and late systemic hypotension as a frequent and fundamental source of cerebral ischemia following severe brain injury in the Traumatic Coma Data Bank. Acta Neurochir Suppl (Wien). 1993;59:121-5. doi: 10.1007/978-3-7091-9302-0_21.

  PMID: 8310858 BACKGROUND

• Fearnside MR, Cook RJ, McDougall P, McNeil RJ. The Westmead Head Injury Project outcome in severe head injury. A comparative analysis of pre-hospital, clinical and CT variables. Br J Neurosurg. 1993;7(3):267-79. doi: 10.3109/02688699309023809.

  PMID: 8338647 BACKGROUND

• Schreiber MA, Aoki N, Scott BG, Beck JR. Determinants of mortality in patients with severe blunt head injury. Arch Surg. 2002 Mar;137(3):285-90. doi: 10.1001/archsurg.137.3.285.

  PMID: 11888450 BACKGROUND

• Jones PA, Andrews PJ, Midgley S, Anderson SI, Piper IR, Tocher JL, Housley AM, Corrie JA, Slattery J, Dearden NM, et al. Measuring the burden of secondary insults in head-injured patients during intensive care. J Neurosurg Anesthesiol. 1994 Jan;6(1):4-14.

  PMID: 8298263 BACKGROUND

• Stocchetti N, Furlan A, Volta F. Hypoxemia and arterial hypotension at the accident scene in head injury. J Trauma. 1996 May;40(5):764-7. doi: 10.1097/00005373-199605000-00014.

  PMID: 8614077 BACKGROUND

• 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. VIII. Intracranial pressure thresholds. J Neurotrauma. 2007;24 Suppl 1:S55-8. doi: 10.1089/neu.2007.9988. No abstract available.

  PMID: 17511546 BACKGROUND

• Marshall LF, Smith RW, Shapiro HM. The outcome with aggressive treatment in severe head injuries. Part I: the significance of intracranial pressure monitoring. J Neurosurg. 1979 Jan;50(1):20-5. doi: 10.3171/jns.1979.50.1.0020. No abstract available.

  PMID: 758374 BACKGROUND

• Saul TG, Ducker TB. Intracranial pressure monitoring in patients with severe head injury. Am Surg. 1982 Sep;48(9):477-80.

  PMID: 7125382 BACKGROUND

• Narayan RK, Kishore PR, Becker DP, Ward JD, Enas GG, Greenberg RP, Domingues Da Silva A, Lipper MH, Choi SC, Mayhall CG, Lutz HA 3rd, Young HF. Intracranial pressure: to monitor or not to monitor? A review of our experience with severe head injury. J Neurosurg. 1982 May;56(5):650-9. doi: 10.3171/jns.1982.56.5.0650. No abstract available.

  PMID: 7069477 BACKGROUND

• 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. XI. Anesthetics, analgesics, and sedatives. J Neurotrauma. 2007;24 Suppl 1:S71-6. doi: 10.1089/neu.2007.9985. No abstract available.

  PMID: 17511550 BACKGROUND

• Nyquist P, Stevens RD, Mirski MA. Neurologic injury and mechanical ventilation. Neurocrit Care. 2008;9(3):400-8. doi: 10.1007/s12028-008-9130-7. Epub 2008 Aug 12.

  PMID: 18696268 BACKGROUND

• Stevens RD, Lazaridis C, Chalela JA. The role of mechanical ventilation in acute brain injury. Neurol Clin. 2008 May;26(2):543-63, x. doi: 10.1016/j.ncl.2008.03.014.

  PMID: 18514826 BACKGROUND

• Dries DJ, Marini JJ. Airway pressure release ventilation. J Burn Care Res. 2009 Nov-Dec;30(6):929-36. doi: 10.1097/BCR.0b013e3181bfb84c. No abstract available.

  PMID: 19826261 BACKGROUND

• Habashi NM. Other approaches to open-lung ventilation: airway pressure release ventilation. Crit Care Med. 2005 Mar;33(3 Suppl):S228-40. doi: 10.1097/01.ccm.0000155920.11893.37.

  PMID: 15753733 BACKGROUND

• Dart BW 4th, Maxwell RA, Richart CM, Brooks DK, Ciraulo DL, Barker DE, Burns RP. Preliminary experience with airway pressure release ventilation in a trauma/surgical intensive care unit. J Trauma. 2005 Jul;59(1):71-6. doi: 10.1097/00005373-200507000-00010.

  PMID: 16096541 BACKGROUND

• Maung AA, Luckianow G, Kaplan LJ. Lessons learned from airway pressure release ventilation. J Trauma Acute Care Surg. 2012 Mar;72(3):624-8. doi: 10.1097/TA.0b013e318247668f.

  PMID: 22491545 BACKGROUND

• Maxwell RA, Green JM, Waldrop J, Dart BW, Smith PW, Brooks D, Lewis PL, Barker DE. A randomized prospective trial of airway pressure release ventilation and low tidal volume ventilation in adult trauma patients with acute respiratory failure. J Trauma. 2010 Sep;69(3):501-10; discussion 511. doi: 10.1097/TA.0b013e3181e75961.

  PMID: 20838119 BACKGROUND

• Andrews PL, Shiber JR, Jaruga-Killeen E, Roy S, Sadowitz B, O'Toole RV, Gatto LA, Nieman GF, Scalea T, Habashi NM. Early application of airway pressure release ventilation may reduce mortality in high-risk trauma patients: a systematic review of observational trauma ARDS literature. J Trauma Acute Care Surg. 2013 Oct;75(4):635-41. doi: 10.1097/TA.0b013e31829d3504.

  PMID: 24064877 BACKGROUND

• Nemer SN, Caldeira JB, Azeredo LM, Garcia JM, Silva RT, Prado D, Santos RG, Guimaraes BS, Ramos RA, Noe RA, Souza PC. Alveolar recruitment maneuver in patients with subarachnoid hemorrhage and acute respiratory distress syndrome: a comparison of 2 approaches. J Crit Care. 2011 Feb;26(1):22-7. doi: 10.1016/j.jcrc.2010.04.015. Epub 2010 Jun 19.

  PMID: 20646904 BACKGROUND

• Marik PE, Young A, Sibole S, Levitov A. The effect of APRV ventilation on ICP and cerebral hemodynamics. Neurocrit Care. 2012 Oct;17(2):219-23. doi: 10.1007/s12028-012-9739-4.

  PMID: 22829002 BACKGROUND

• Kreyer S, Putensen C, Berg A, Soehle M, Muders T, Wrigge H, Zinserling J, Hering R. Effects of spontaneous breathing during airway pressure release ventilation on cerebral and spinal cord perfusion in experimental acute lung injury. J Neurosurg Anesthesiol. 2010 Oct;22(4):323-9. doi: 10.1097/ANA.0b013e3181e775f1.

  PMID: 20622682 BACKGROUND

MeSH Terms

Conditions

Brain Injuries, Traumatic

Interventions

Continuous Positive Airway Pressure

Condition Hierarchy (Ancestors)

Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Positive-Pressure Respiration; Respiration, Artificial; Airway Management; Therapeutics; Respiratory Therapy

Limitations and Caveats

This study was limited by poor patient enrollment. Thus, sufficient data was not collected for true analysis. Furthermore, access to LTOV and APRV intracranial pressure data lost and can not be reported.

Results Point of Contact

• Title: Dr Deborah Stein
• Organization: The R Adams Cowley Shock Trauma Center

dstein@umm.edu

410-328-3495

Study Officials

• Deborah M Stein, MD, MPH

  Professor, Department of Surgery

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Director, Neurotrauma Critical Care; Chief, Section of Trauma Critical Care, R Adams Cowley Shock Trauma Center

Study Record Dates

• First Submitted: July 17, 2015
• First Posted: July 24, 2015
• Study Start: July 1, 2015
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: January 28, 2022
• Results First Posted: January 9, 2020

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)