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Unable to successfully recruit patients for study.
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
| |
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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All patients with intracranial pressure monitor requiring mechanical ventilation support will be eligible for enrollment in the study
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| Name | Affiliation | Role |
|---|---|---|
| Deborah M Stein, MD, MPH | Professor, Department of Surgery | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| RA Cowley Shock Trauma Center | Baltimore | Maryland | 21201 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 1751154 | Background | Bosio A. A theoretical study of new types of valve shunts for cerebrospinal fluid. ASAIO Trans. 1991 Jul-Sep;37(3):M289-90. | |
| 8310858 | 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. |
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8 of 200 patients were randomized. The other patients were excluded as they did not meet the eligibility criteria.
200 patients were screened for eligibility between July 2015 and April 2018 at University of Maryland, Baltimore.
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| ID | Title | Description |
|---|---|---|
| FG000 | LOTV, Then APRV | Participants first were maintained on Low Tidal Volume Ventilation for two hours. Then there was a washout period of 30 minutes. After this washout period, they were maintained on Airway Pressure Release Ventilation for two hours. 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 24, 2015 |
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| 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 |
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| 8338647 | 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. |
| 11888450 | 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. |
| 8298263 | 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. |
| 8614077 | 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. |
| 17511546 | 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. |
| 758374 | 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. |
| 7125382 | Background | Saul TG, Ducker TB. Intracranial pressure monitoring in patients with severe head injury. Am Surg. 1982 Sep;48(9):477-80. |
| 7069477 | 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. |
| 17511550 | 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. |
| 18696268 | 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. |
| 18514826 | 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. |
| 19826261 | 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. |
| 15753733 | 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. |
| 16096541 | 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. |
| 22491545 | 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. |
| 20838119 | 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. |
| 24064877 | 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. |
| 20646904 | 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. |
| 22829002 | 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. |
| 20622682 | 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. |
| COMPLETED |
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| NOT COMPLETED |
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Participants first were maintained on Low Tidal Volume Ventilation for two hours. Then there was a washout period of 30 minutes. After this washout period, they were maintained on Airway Pressure Release Ventilation for two hours.
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| ID | Title | Description |
|---|---|---|
| BG000 | LOTV Then APRV | Participants first were maintained on Low Tidal Volume Ventilation for two hours. Then there was a washout period of 30 minutes. After this washout period, they were maintained on Airway Pressure Release Ventilation for two hours. 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants | Participants |
| ||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||||
| Patients Not Initially on APRV | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Access to original intracranial pressure data lost and cannot be summarized No data was analyzed to report. | Posted | On average, 24 hours for each patient |
|
|
1 day
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | LOTV | All Participants first were maintained on Low Tidal Volume Ventilation for two hours. Then there was a washout period of 30 minutes. After this washout period, they were maintained on Airway Pressure Release Ventilation for two hours. 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. Patient's volume statuses and cardiac functions were assessed during the study period No data was analyzed to report. | 0 | 8 | 1 | 8 | 0 | 8 |
| EG001 | APRV | All Participants first were maintained on Low Tidal Volume Ventilation for two hours. Then there was a washout period of 30 minutes. After this washout period, they were maintained on Airway Pressure Release Ventilation for two hours. 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. Patient's volume statuses and cardiac functions were assessed during the study period No data was analyzed to report. | 0 | 8 | 1 | 8 | 0 | 8 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Increased systolic blood pressure | Blood and lymphatic system disorders | Systematic Assessment | One patient enrolled in the trial had a spike in systolic blood pressure to just above 300 mmHg when switched to APRV. The trial immediately terminated in this patient, and the systolic blood pressure returned to within normal limits. |
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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.
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Deborah Stein | The R Adams Cowley Shock Trauma Center | 410-328-3495 | dstein@umm.edu |
| Mar 20, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| ID | Term |
|---|---|
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D045422 | Continuous Positive Airway Pressure |
| ID | Term |
|---|---|
| D011175 | Positive-Pressure Respiration |
| D012121 | Respiration, Artificial |
| D058109 | Airway Management |
| D013812 | Therapeutics |
| D012138 | Respiratory Therapy |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
|