CDE Detailed Report

Disease: Unruptured Cerebral Aneurysms and Subarachnoid Hemorrhage
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CRF: Intracranial Pressure (ICP) Monitoring

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CDE ID CDE Name Variable Name Definition Short Description Additional Notes (Question Text) Permissible Values Description Data Type Disease Specific Instructions Disease Specific Reference Population Classification (e.g., Core) Version Number Version Date CRF Name (CRF Module / Guideline) Sub Domain Name Domain Name Size Input Restrictions Min Value Max Value Measurement Type External Id Loinc External Id Snomed External Id caDSR External Id CDISC
C01573 Intracranial pressure measurement ICPMeasr Measurement of intracranial pressure (ICP), the amount of pressure that the cranium exerts on brain tissue, the brain's blood volume, and cerebrospinal fluid Measurement of intracranial pressure (ICP), the amount of pressure that the cranium exerts on brain tissue, the brain's blood volume, and cerebrospinal fluid Intracranial pressure measurement (mmHg) Numeric Values

Recommend collection during acute hospital care. The recommended reference range is -10 to 300 mmHg. Add date stamp for when assessed.

Guidelines for the management of severe traumatic brain injury. VIII. Intracranial pressure thresholds. J Neurotrauma. 2007;24 Suppl 1:S55-8. Vik A, Nag T, Fredriksli OA, et al. Relationship of "dose" of intracranial hypertension to outcome in severe traumatic brain injury. J Neurosurg. Oct 2008;109(4):678-684. Pediatric-specific reference(s): Adelson PD, Bratton SL, Carney, NA, Chesnut RM, du Coudray HE, Goldstein B, Kochanek PM, Miller HC, Partington MD, Selden NR, Warden CR, Wright DW. Guidelines for the acute medical management of severe traumatic brain injury in infants, children, and adolescents. Chapter 6. Threshold for treatment of intracranial hypertension. (2003a). Pediatr Crit Care Med 4:S25-S27. Adult;Pediatric Supplemental 4.00 2017-01-25 11:30:22.0 Intracranial Pressure (ICP) Monitoring [php] [php_1]

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C01574 Intracranial pressure maximum daily measurement ICPMaxDailyMeasr Highest measurement of the participant's/ subject's intracranial pressure (ICP) over the 24-hour period Highest measurement of the participant's/ subject's intracranial pressure (ICP) over the 24-hour period Intracranial pressure maximum daily measurement (mmHg) Numeric Values

The suggested range is -10 to 300 mmHg. Recommend collection during acute hospital care. Add date stamp for when assessed. It is recommended to document the highest ICP, zeroing the ICP monitor at the level of the foramen of Monro and to relate all hourly data to date and time of injury, as being the only fixed time event across patients. Monitoring for and treating raised ICP is an important element in the management of patients with severe TBI. Pediatric-specific notes: As a minimum, vital signs should be recorded on admission and further, on a daily basis during the acute phase after injury. For the Core datasets, we recommend recording the average and lowest blood pressure over a given period. In the ICU environment, recording blood pressure on an hourly basis is recommended, especially when intracranial pressure (ICP) is monitored in order to permit determination of CPP, calculated as mean arterial blood pressure (MABP) - ICP (intermediate data set). For valid comparison of results between patients and across studies, a common approach towards zeroing the ICP monitor should be agreed upon. For fluid coupled systems we suggest that the ICP monitor be zeroed to the level of the foramen of Monro.

Guidelines for the management of severe traumatic brain injury. VIII. Intracranial pressure thresholds. J Neurotrauma. 2007;24 Suppl 1:S55-8. Vik A, Nag T, Fredriksli OA, et al. Relationship of "dose" of intracranial hypertension to outcome in severe traumatic brain injury. J Neurosurg. Oct 2008;109(4):678-684. Pediatric-specific reference(s): Adelson PD, Bratton SL, Carney, NA, Chesnut RM, du Coudray HE, Goldstein B, Kochanek PM, Miller HC, Partington MD, Selden NR, Warden CR, Wright DW. Guidelines for the acute medical management of severe traumatic brain injury in infants, children, and adolescents. Chapter 6. Threshold for treatment of intracranial hypertension. (2003a). Pediatr Crit Care Med 4:S25-S27. Adult;Pediatric Supplemental 4.00 2017-01-25 11:29:38.0 Intracranial Pressure (ICP) Monitoring [php] [php_1]

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C01575 Intracranial pressure mean daily measurement ICPMeanDailyMeasr Mean measurement of the participant's/ subject's intracranial pressure (ICP) over the 24-hour period Mean measurement of the participant's/ subject's intracranial pressure (ICP) over the 24-hour period Intracranial pressure mean daily measurement (mmHg) Numeric Values

The suggested range is -10 to 300 mmHg. Recommend collection during acute hospital care. Add date stamp for when assessed. Record the average ICP on a daily basis. The average does not need to be the mathematical average of multiple measurements, but rather the value most representative of this 'daily' period. It is recommended to zero the ICP monitor at the level of the foramen of Monro and to relate all hourly data to date and time of injury, as being the only fixed time event across patients. Monitoring for and treating raised ICP is an important element in the management of patients with severe TBI.

Guidelines for the management of severe traumatic brain injury. VIII. Intracranial pressure thresholds. J Neurotrauma. 2007;24 Suppl 1:S55-8. Vik A, Nag T, Fredriksli OA, et al. Relationship of "dose" of intracranial hypertension to outcome in severe traumatic brain injury. J Neurosurg. Oct 2008;109(4):678-684 Adult;Pediatric Supplemental 4.00 2017-01-25 11:29:14.0 Intracranial Pressure (ICP) Monitoring [php] [php_1]

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C01576 Intracranial pressure episode greater 20 mmHg longer 5 minutes count ICPEps20mmHG5MinDurCt Count of episodes where the participant's/subject's intracranial pressure was greater than 20 mmHg lasting for longer than five minutes Count of episodes where the participant's/subject's intracranial pressure was greater than 20 mmHg lasting for longer than five minutes Intracranial pressure episodes greater than 20 mmHg lasting longer than five minutes Numeric Values

Recommend collection during acute hospital care. Add date stamp for when assessed.

No references available Adult;Pediatric Supplemental 3.00 2013-07-20 10:21:25.65 Intracranial Pressure (ICP) Monitoring [php] [php_1]

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C01566 Intracranial pressure monitoring start date and time ICPMonitorStartDateTime Date (and time, if applicable and known) the intracranial pressure (ICP) monitoring began Date (and time, if applicable and known) the intracranial pressure (ICP) monitoring began ICP monitoring start date Date or Date & Time

Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (http://www.iso.org/iso/home.html). The date/time should be recorded to the level of granularity known (e.g., year, year and month, complete date plus hours and minutes, etc.).

Guidelines for the management of severe traumatic brain injury. VII. Intracranial pressure monitoring technology. J Neurotrauma. 2007;24 Suppl 1:S45-54. Adult;Pediatric Supplemental 3.00 2013-07-20 10:21:25.65 Intracranial Pressure (ICP) Monitoring [php] [php_1]

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C01577 Intracranial pressure episode greater 20 mmHg count ICPEpisodOver20mmHgCt Count of episodes where the participant's/subject's intracranial pressure was greater than 20 mmHg Count of episodes where the participant's/subject's intracranial pressure was greater than 20 mmHg Intracranial pressure episodes greater than 20 mmHG Numeric Values

Recommend collection during acute hospital care. Add date stamp for when assessed.

No references available Adult;Pediatric Supplemental 3.00 2013-07-20 10:21:25.65 Intracranial Pressure (ICP) Monitoring [php] [php_1]

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C01567 Intracranial pressure monitoring stopped reason ICPMonitorStopRsn Primary reason the intracranial pressure (ICP) monitoring of the participant/subject was stopped Primary reason the intracranial pressure (ICP) monitoring of the participant/subject was stopped Reason ICP monitoring was stopped Clinically improved/no longer required;Patient considered unsalvageable/futility;Monitor/catheter failure;Patient died;Unknown Clinically improved/no longer required;Patient considered unsalvageable/futility;Monitor/catheter failure;Patient died;Unknown Alphanumeric

Choose one. Documentation of the reason for stopping monitoring is relevant when interpreting measured values and their relation to therapy intensity.

Guidelines for the management of severe traumatic brain injury. VII. Intracranial pressure monitoring technology. J Neurotrauma. 2007;24 Suppl 1:S45-54. Adult;Pediatric Supplemental 3.00 2013-07-20 10:21:25.65 Intracranial Pressure (ICP) Monitoring [php] [php_1]

Single Pre-Defined Value Selected

C01578 Cerebral perfusion pressure value CerebrlPerfusPressrVal Value of the difference between the Mean Arterial Pressure (MAP) and the Intracranial Pressure (ICP). It represents the pressure gradient driving cerebral blood flow and hence oxygen and metabolite delivery. Value of the difference between the Mean Arterial Pressure (MAP) and the Intracranial Pressure (ICP). It represents the pressure gradient driving cerebral blood flow and hence oxygen and metabolite delivery. Cerebral perfusion pressure value (mmHg) Numeric Values

Calculate Cerebral Perfusion Pressure using the formula CPP = MABP- ICP. In the ICU environment, recording blood pressure on an hourly basis is recommended, especially when intracranial pressure (ICP) is monitored in order to permit determination of CPP, calculated as mean arterial blood pressure (MABP) - ICP (supplemental data set).

No references available Adult;Pediatric Supplemental 3.00 2013-07-20 10:21:25.65 Intracranial Pressure (ICP) Monitoring [php] [php_1]

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C01568 Intracranial pressure monitoring stop date and time ICPMonitorStopDateTime Date (and time, if applicable and known) the intracranial pressure (ICP) catheter was removed from the participant/subject and the ICP monitoring was stopped Date (and time, if applicable and known) the intracranial pressure (ICP) catheter was removed from the participant/subject and the ICP monitoring was stopped ICP monitoring stop date and time Date or Date & Time

Record the date/time according to the ISO 8601, the International Standard for the representation of dates and times (http://www.iso.org/iso/home.html). The date/time should be recorded to the level of granularity known (e.g., year, year and month, complete date plus hours and minutes, etc.).

Guidelines for the management of severe traumatic brain injury. VII. Intracranial pressure monitoring technology. J Neurotrauma. 2007;24 Suppl 1:S45-54. Adult;Pediatric Supplemental 3.00 2013-07-20 10:21:25.65 Intracranial Pressure (ICP) Monitoring [php] [php_1]

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C01579 Cerebral perfusion pressure episodes lower 60 mmHg number CerbrlPerfsnPrsrEpLwr60mmHgNum Number of episodes of critical cerebral perfusion pressure less than 60 mmHg Number of episodes of critical cerebral perfusion pressure less than 60 mmHg Cerebral perfusion pressure episodes lower than 60 mmHg Numeric Values

Recommend collection during acute hospital care. Add date stamp for when assessed.

Chambers, I., Jones, P., Lo, T., Forsyth, R., Fulton, B., Andrews, P., Mendelow, A., and Minns, R. (2006). Critical thresholds of intracranial pressure and cerebral perfusion pressure related to age in paediatric head injury. J. Neurol. Neurosurg. Psych. 77, 234-240. Adult;Pediatric Supplemental 3.00 2013-07-20 10:21:25.65 Intracranial Pressure (ICP) Monitoring [php] [php_1]

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C01569 Intracranial pressure monitoring problem type ICPMonitorProbType Type of problem experienced when monitoring the participant's/subject's intracranial pressure (ICP) which may lead to inaccurate interpretation of measured values. Type of problem experienced when monitoring the participant's/subject's intracranial pressure (ICP) which may lead to inaccurate interpretation of measured values. Type of problem experienced during ICP monitoring Catheter obstruction/failure;Suspicion of inaccurate measurement;None;Other, specify;Accidental catheter removal Catheter obstruction/failure;Suspicion of inaccurate measurement;None;Other, specify;Accidental catheter removal Alphanumeric

Choose all that apply. Recommend collection on a daily basis. Measured values may be influenced by catheter malfunction. It is therefore highly important to document possible problems in ICP monitoring.

Smith M. Monitoring intracranial pressure in traumatic brain injury. Anesth Analg. Jan 2008;106(1):240-248. Adult;Pediatric Supplemental 3.00 2013-07-20 10:21:25.65 Intracranial Pressure (ICP) Monitoring [php] [php_1]

Multiple Pre-Defined Values Selected

C18725 Intracranial pressure catheter anatomic site other text ICPCathetrAnatSiteOTH The free-text field related to 'Intracranial pressure catheter anatomic site' specifying other text. Anatomic site where the intracranial pressure (ICP) catheter is implanted in the participant/subject The free-text field related to 'Intracranial pressure catheter anatomic site' specifying other text. Anatomic site where the intracranial pressure (ICP) catheter is implanted in the participant/subject Other, specify: Alphanumeric

Choose one. The reliability and comparability of measured values may in part depend on the device used.

Guidelines for the management of severe traumatic brain injury. VII. Intracranial pressure monitoring technology. J Neurotrauma. 2007;24 Suppl 1:S45-54. Adult;Pediatric Supplemental 1.00 2014-05-27 13:34:46.0 Intracranial Pressure (ICP) Monitoring [php] [php_1] 4000

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C01570 Intracranial pressure catheter revised indicator ICPCathetrReviseInd Indicator of whether the intracranial pressure (ICP) catheter was revised due to problems with ICP monitoring which may lead to inaccurate interpretation of measured values. Indicator of whether the intracranial pressure (ICP) catheter was revised due to problems with ICP monitoring which may lead to inaccurate interpretation of measured values. Was the intracranial pressure catheter indicator revised? Yes;No;Unknown Yes;No;Unknown Alphanumeric

Choose one. To be completed on a daily basis. Measured values may be influenced by catheter malfunction. It is therefore highly important to document possible problems in ICP monitoring.

Smith M. Monitoring intracranial pressure in traumatic brain injury. Anesth Analg. Jan 2008;106(1):240-248. Adult;Pediatric Supplemental 3.00 2013-07-20 10:21:25.65 Intracranial Pressure (ICP) Monitoring [php] [php_1]

Single Pre-Defined Value Selected

C18726 Intracranial pressure device other text ICPDeviceOTH The free-text field related to 'Intracranial pressure device type' specifying other text. Type of intracranial pressure (ICP) device implanted in the participant/subject The free-text field related to 'Intracranial pressure device type' specifying other text. Type of intracranial pressure (ICP) device implanted in the participant/subject Other, specify: Alphanumeric

Choose one. The reliability and comparability of measured values may in part depend on the device used.

Guidelines for the management of severe traumatic brain injury. VII. Intracranial pressure monitoring technology. J Neurotrauma. 2007;24 Suppl 1:S45-54. Adult;Pediatric Supplemental 1.00 2014-05-27 13:34:46.0 Intracranial Pressure (ICP) Monitoring [php] [php_1] 4000

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C01571 Intracranial pressure catheter anatomic site ICPCathetrAntmicSite Anatomic site where the intracranial pressure (ICP) catheter is implanted in the participant/subject Anatomic site where the intracranial pressure (ICP) catheter is implanted in the participant/subject Intracranial pressure catheter atomic site Intraparenchymal;Epidural;Intraventricular;Subdural;Other, specify Intraparenchymal;Epidural;Intraventricular;Subdural;Other, specify Alphanumeric

Choose one. The reliability and comparability of measured values may in part depend on the device used.

Guidelines for the management of severe traumatic brain injury. VII. Intracranial pressure monitoring technology. J Neurotrauma. 2007;24 Suppl 1:S45-54. Adult;Pediatric Supplemental 3.00 2013-07-20 10:21:25.65 Intracranial Pressure (ICP) Monitoring [php] [php_1]

Single Pre-Defined Value Selected

C18727 Intracranial pressure monitoring problem other text ICPMonitorProbOTH The free-text field related to 'Intracranial pressure monitoring problem type' specifying other text. Type of problem experienced when monitoring the participant's/subject's intracranial pressure (ICP) which may lead to inaccurate interpretation of measured values Free-text field to 'Intracranial pressure monitoring problem type' specifying other text. Type of problem experienced when monitoring the participant's/subject's intracranial pressure (ICP) which may lead to inaccurate interpretation of measured values. Other, specify: Alphanumeric

Choose all that apply. Recommend collection on a daily basis. Measured values may be influenced by catheter malfunction. It is therefore highly important to document possible problems in ICP monitoring.

Smith M. Monitoring intracranial pressure in traumatic brain injury. Anesth Analg. Jan 2008;106(1):240-248. Adult;Pediatric Supplemental 1.00 2014-05-27 13:34:46.0 Intracranial Pressure (ICP) Monitoring [php] [php_1] 4000

Free-Form Entry

C01572 Intracranial pressure device type ICPDeviceType Type of intracranial pressure (ICP) device implanted in the participant/subject Type of intracranial pressure (ICP) device implanted in the participant/subject Intracranial pressure device type Intraparenchymal;Other, specify;Ventriculostomy Intraparenchymal;Other, specify;Ventriculostomy Alphanumeric

Choose one. The reliability and comparability of measured values may in part depend on the device used.

Guidelines for the management of severe traumatic brain injury. VII. Intracranial pressure monitoring technology. J Neurotrauma. 2007;24 Suppl 1:S45-54. Adult;Pediatric Supplemental 3.00 2013-07-20 10:21:25.65 Intracranial Pressure (ICP) Monitoring [php] [php_1]

Single Pre-Defined Value Selected

CSV