Study of Airway Pressure Release Ventilation and Intracranial Pressure in Patients With Severe Traumatic Brain Injury
NCT ID: NCT02507973
Last Updated: 2022-01-28
Study Results
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View full resultsBasic Information
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TERMINATED
8 participants
OBSERVATIONAL
2015-07-31
2018-04-30
Brief Summary
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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.
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CROSSOVER
PROSPECTIVE
Study Groups
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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.
Airway Pressure Release Ventilation
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.
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.
Low Tidal Volume Ventilation
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
Interventions
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Airway Pressure Release Ventilation
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.
Low Tidal Volume Ventilation
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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Mechanically Ventilated
* Clinically Stable as determined by the Critical Care attending
Exclusion Criteria
* Prisoners
* Initial Mode of ventilation is APRV
* Provider's Judgement
* Pregnant
14 Years
ALL
No
Sponsors
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University of Maryland, Baltimore
OTHER
Responsible Party
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Deborah Stein
Medical Director, Neurotrauma Critical Care; Chief, Section of Trauma Critical Care, R Adams Cowley Shock Trauma Center
Principal Investigators
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Deborah M Stein, MD, MPH
Role: PRINCIPAL_INVESTIGATOR
Professor, Department of Surgery
Locations
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RA Cowley Shock Trauma Center
Baltimore, Maryland, United States
Countries
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References
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Bosio A. A theoretical study of new types of valve shunts for cerebrospinal fluid. ASAIO Trans. 1991 Jul-Sep;37(3):M289-90.
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.
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.
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.
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.
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.
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.
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.
Saul TG, Ducker TB. Intracranial pressure monitoring in patients with severe head injury. Am Surg. 1982 Sep;48(9):477-80.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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HP-00063355
Identifier Type: -
Identifier Source: org_study_id
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