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

Traumatic Brain Injury Clinical Trial

Official title:

Study of APRV and ICP in Patients With Severe Traumatic Brain Injury

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02507973
• Other study ID #: HP-00063355
• Status: Terminated
• Start date: July 2015
• Est. completion date: April 2018

Study information

• Verified date: January 2022
• Source: University of Maryland, Baltimore
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

Each participant at admission will initially receive a primary mode of mechanical ventilation as determined by the attending trauma intensivists. 12-18 hours after recruitment, continuous monitoring of participants' ICP and hemodynamic status will commence to collect participants' baseline data for 30 minutes. 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 8
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 14 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Brain Injuries
• Brain Injuries, Traumatic
• Injury, Brain, Traumatic
• Traumatic Brain Injury
• Wounds and Injuries

Intervention

Other:
• 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

Locations

Country	Name	City	State
United States	RA Cowley Shock Trauma Center	Baltimore	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
University of Maryland, Baltimore

Country where clinical trial is conducted

United States, 

References & Publications (22)

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. Review. — View Citation

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

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. Erratum in: J Neurotrauma. 2008 Mar;25(3):276-8. multiple author names added. — View Citation

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. Erratum in: J Neurotrauma. 2008 Mar;25(3):276-8. multiple author names added. — View Citation

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. — View Citation

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. — View Citation

Dries DJ, Marini JJ. Airway pressure release ventilation. J Burn Care Res. 2009 Nov-Dec;30(6):929-36. doi: 10.1097/BCR.0b013e3181bfb84c. Review. — View Citation

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. — View Citation

Habashi NM. Other approaches to open-lung ventilation: airway pressure release ventilation. Crit Care Med. 2005 Mar;33(3 Suppl):S228-40. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Nemer SN, Caldeira JB, Azeredo LM, Garcia JM, Silva RT, Prado D, Santos RG, Guimarães BS, Ramos RA, Noé 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. — View Citation

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. Review. — View Citation

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

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. — View Citation

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. Review. — View Citation

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. — View Citation

* Note: There are 22 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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