CDE Detailed Report

Disease: content
Subdomain Name: Second Insults
CRF: welcome

Displaying 1 - 13 of 13
CDE ID CDE Name Variable Name Definition Short Description 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 / Guidance) Subdomain Name Domain Name Size Input Restrictions Min Value Max Value Measurement Type External Id Loinc External Id Snomed External Id caDSR External Id CDISC
C05460 Seizure indicator SeizInd Indicator of seizure activity Indicator of seizure activity Did participant/subject experience seizure(s)? Yes;No;Suspected;Unknown Yes;No;Suspected;Unknown Alphanumeric

Choose one. Seizure activity in the brain may cause focal or generalized vasodilation with increased cerebral blood volume and high intracranial pressure. Moreover, metabolic requirements are increased in a situation where brain metabolism is already compromised. Seizures are therefore an important second insult following TBI.

McHugh GS, Engel DC, Butcher I, et al. Prognostic value of secondary insults in traumatic brain injury: results from the IMPACT study. J Neurotrauma. Feb 2007;24(2):287-93. Signorini DF, Andrews PJ, Jones PA, et al. Adding insult to injury: the prognostic value of early secondary insults for survival after traumatic brain injury. J Neurol Neurosurg Psychiatry. Jan 1999;66(1):26-31 Adult;Pediatric Supplemental 3.00 2013-07-20 10:21:25.65 Second Insults and Other Complications Second Insults Disease/Injury Related Events

Single Pre-Defined Value Selected

C05461 Seizure presentation type SeizPresentTyp Type of seizure activity as convulsive or non-convulsive (diagnosed on EEG only, no motor manifestations) Type of seizure activity as convulsive or non-convulsive (diagnosed on EEG only, no motor manifestations) Presentation of seizure Convulsive;Non-convulsive Convulsive;Non-convulsive Alphanumeric

Choose one. This element is only answered if the participant/subject had a seizure. This element is recommended for pediatric studies. Second insults are commonly defined by threshold values but these values are not well established in pediatrics. Based on the available data for pediatric TBI , thresholds of 80-180 mg/dL for glucose are recommended. A threshold for hemoglobin is more difficult to define given emerging data on the lower limit of hemoglobin safely tolerated by critically ill children in general and the variable effect of blood transfusion in children with severe TBI specifically.

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. uidelines 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 3.00 2013-07-20 10:21:25.65 Second Insults and Other Complications Second Insults Disease/Injury Related Events

Single Pre-Defined Value Selected

C05462 Seizure duration type SeizDurType Seizure described as intermittent or status epilepticus. Convulsive status epilepticus (CSE) is defined as either 2 or more convulsions without complete recovery of consciousness between seizures (intermittent CSE) or as a single prolonged seizure that lasts for at least 30 minutes (continuous CSE) Seizure described as intermittent or status epilepticus. Convulsive status epilepticus (CSE) is defined as either 2 or more convulsions without complete recovery of consciousness between seizures (intermittent CSE) or as a single prolonged seizure that lasts for at least 30 minutes (continuous CSE Seizure duration type Intermittent;Status epilepticus Intermittent;Status epilepticus Alphanumeric

Choose one. This element is only answered if the participant/subject had a seizure. This element is recommended for pediatric studies.

Ostrowsky K, Arzimanoglou A. Outcome and prognosis of status epilepticus in children. Semin Pediatr Neurol. 2010 Sep;17(3):195-200. Adult;Pediatric Supplemental 3.00 2013-07-20 10:21:25.65 Second Insults and Other Complications Second Insults Disease/Injury Related Events

Single Pre-Defined Value Selected

C05463 EEG monitoring type EEGMonitorType Type of electroencephalogram (EEG) monitoring Type of electroencephalogram (EEG) monitoring EEG monitoring type Routine;Continuous/prolonged Routine;Continuous/prolonged Alphanumeric

Choose one. Response is obtained from medical charts and/or patient data management system. This element is recommended for pediatric studies.

No references available Adult;Pediatric Supplemental 3.00 2013-08-28 16:08:00.453 Second Insults and Other Complications Second Insults Disease/Injury Related Events

Single Pre-Defined Value Selected

C05453 Hypotensive episode indicator HypotnsnEpiInd Indicator of hypotensive episode. In adults, hypotensive episode is defined as systolic blood pressure < 90 mmHg. In children, it is defined as systolic blood pressure < 5th percentile for age Indicator of hypotensive episode. In adults, hypotensive episode is defined as systolic blood pressure < 90 mmHg. In children, it is defined as systolic blood pressure < 5th percentile for age Did participant/subject experience hypotensive episode? Yes;No;Unknown;Suspected Yes;No;Unknown;Suspected Alphanumeric

Choose one.

McHugh GS, Engel DC, Butcher I, et al. Prognostic value of secondary insults in traumatic brain injury: results from the IMPACT study. J Neurotrauma. Feb 2007;24(2):287-93. Silverstone P. Pulse oxymetry of at the road side: a study of pulse oxymetry in immediate care. BMJ. Mar 1989;298(6675):711-13. Stocchetti N, Furlan A, Volta F. Hypoxemia and arterial hypotension at the accident side in head injury. J Trauma. 1996;40:764-67. De Witt DS, Jenkins LW, Prough DS. Enhanced vulnerability to secondary ischemic insults after experimental traumatic brain injury. New Horizon. Aug 1995;3(3):376-383. Adult;Pediatric Supplemental 3.00 2013-07-20 10:21:25.65 Second Insults and Other Complications Second Insults Disease/Injury Related Events

Single Pre-Defined Value Selected

C05464 Hyperventilation indicator HyperventInd Indicator of hyperventilation. Hyperventilation is defined as rapid, deep breathing, possibly exceeding 40 breaths/minute Indicator of hyperventilation. Hyperventilation is defined as rapid, deep breathing, possibly exceeding 40 breaths/minute Did participant/subject experience hyperventilation? Yes;No;Unknown;Suspected Yes;No;Unknown;Suspected Alphanumeric

Choose one. Response is obtained from medical charts and/or patient data management system.

Chesnut RM, Marshall LF, Klauber MR, Blunt BA, Baldwin N, Eisenberg HM, Jane JA, Marmarou A, Foulkes MA. The role of secondary brain injury in determining outcome from severe head injury. J Trauma. 1993 Feb;34(2):216-22. McHugh GS, Engel DC, Butcher I, et al. Prognostic value of secondary insults in traumatic brain injury: results from the IMPACT study. J Neurotrauma. Feb 2007;24(2):287-93. Signorini DF, Andrews PJ, Jones PA, et al. Adding insult to injury: the prognostic value of early secondary insults for survival after traumatic brain injury. J Neurol Neurosurg Psychiatry. Jan 1999;66(1):26-31 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. uidelines 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 3.00 2013-07-20 10:21:25.65 Second Insults and Other Complications Second Insults Disease/Injury Related Events

Single Pre-Defined Value Selected

C05454 Hypertension indicator HypertensInd Indicator of hypertension. In adults, hypertension is defined as a systolic pressure >= 140 and a diastolic >= 90. In children, it is defined as systolic blood pressure >95th percentile for age Indicator of hypertension. In adults, hypertension is defined as a systolic pressure >= 140 and a diastolic >= 90. In children, it is defined as systolic blood pressure >95th percentile for ag Did participant/subject experience hypertension? Yes;No;Unknown;Suspected Yes;No;Unknown;Suspected Alphanumeric

Choose one. This element is recommended for pediatric studies. Second insults may aggravate processes of secondary damage in a brain already rendered vulnerable by the primary injury. The main physiologic insults relevant to TBI are hypotension, hyper- or hypothermia, hypoxia, and hypocapnia due to hyperventilation. The adverse effect of the occurrence of such insults both pre- and in-hospital is well established. Second insults are commonly defined by threshold values but these values are not well established in pediatrics. Based on the available data for pediatric TBI , thresholds of 80-180 mg/dL for glucose are recommended. A threshold for hemoglobin is more difficult to define given emerging data on the lower limit of hemoglobin safely tolerated by critically ill children in general and the variable effect of blood transfusion in children with severe TBI specifically.

McHugh GS, Engel DC, Butcher I, et al. Prognostic value of secondary insults in traumatic brain injury: results from the IMPACT study. J Neurotrauma. Feb 2007;24(2):287-93. Signorini DF, Andrews PJ, Jones PA, et al. Adding insult to injury: the prognostic value of early secondary insults for survival after traumatic brain injury. J Neurol Neurosurg Psychiatry. Jan 1999;66(1):26-31 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. uidelines 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 3.00 2013-07-20 10:21:25.65 Second Insults and Other Complications Second Insults Disease/Injury Related Events

Single Pre-Defined Value Selected

C05465 Aspiration indicator AspiratnInd Indicator of foreign material breathed into the airway Indicator of foreign material breathed into the airway Did participant/subject experience aspiration of foreign materials? Yes;No;Unknown;Suspected Yes;No;Unknown;Suspected Alphanumeric

Choose one. Response is obtained from medical charts and/or patient data management system. This element is recommended for pediatric studies. Second insults may aggravate processes of secondary damage in a brain already rendered vulnerable by the primary injury. The main physiologic insults relevant to TBI are hypotension, hyper- or hypothermia, hypoxia, and hypocapnia due to hyperventilation. The adverse effect of the occurrence of such insults both pre- and in-hospital is well established. Second insults are commonly defined by threshold values but these values are not well established in pediatrics. Based on the available data for pediatric TBI , thresholds of 80-180 mg/dL for glucose are recommended. A threshold for hemoglobin is more difficult to define given emerging data on the lower limit of hemoglobin safely tolerated by critically ill children in general and the variable effect of blood transfusion in children with severe TBI specifically.

Chesnut RM, Marshall LF, Klauber MR, Blunt BA, Baldwin N, Eisenberg HM, Jane JA, Marmarou A, Foulkes MA. The role of secondary brain injury in determining outcome from severe head injury. J Trauma. 1993 Feb;34(2):216-22. McHugh GS, Engel DC, Butcher I, et al. Prognostic value of secondary insults in traumatic brain injury: results from the IMPACT study. J Neurotrauma. Feb 2007;24(2):287-93. Signorini DF, Andrews PJ, Jones PA, et al. Adding insult to injury: the prognostic value of early secondary insults for survival after traumatic brain injury. J Neurol Neurosurg Psychiatry. Jan 1999;66(1):26-31 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. uidelines 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 3.00 2013-07-20 10:21:25.65 Second Insults and Other Complications Second Insults Disease/Injury Related Events

Single Pre-Defined Value Selected

C05455 Hypothermia indicator HypothermInd Indicator of hypothermia. Hypothermia is defined as core temperature < 35 degrees Celsius Indicator of hypothermia. Hypothermia is defined as core temperature < 35 degrees Celsius Did participant/subject experience hypothermia? Yes;No;Unknown;Suspected Yes;No;Unknown;Suspected Alphanumeric

Choose one. Add date stamp for when assessed. Recommend collection at least during initial medical treatment. Second insults may be systemic (extracranial or intracranial). Second insults aggravate processes of secondary damage in a brain already rendered vulnerable by the primary injury. The occurrence of second insults occurring before hospital admission in patients with more severe injuries, is frequent: oxygen saturation below 90% is found in 44 to 55% of cases and hypotension in 20 to 30%. The occurrence of second insults is strongly associated with poorer outcome. Hypoxia, hypotension and inadvertent hypocapnia are the most frequent causes of jugular desaturations, and periods of low brain tissue oxygen tension. The depth and duration of systemic second insults during the clinical course is related to poorer outcome.

McHugh GS, Engel DC, Butcher I, et al. Prognostic value of secondary insults in traumatic brain injury: results from the IMPACT study. J Neurotrauma. Feb 2007;24(2):287-93. Silverstone P. Pulse oxymetry of at the road side: a study of pulse oxymetry in immediate care. BMJ. Mar 1989;298(6675):711-13. Stocchetti N, Furlan A, Volta F. Hypoxemia and arterial hypotension at the accident side in head injury. J Trauma. 1996;40:764-67. De Witt DS, Jenkins LW, Prough DS. Enhanced vulnerability to secondary ischemic insults after experimental traumatic brain injury. New Horizon. Aug 1995;3(3):376-383. Adult;Pediatric Supplemental 3.00 2013-07-20 10:21:25.65 Second Insults and Other Complications Second Insults Disease/Injury Related Events

Single Pre-Defined Value Selected

C05456 Hyperthermia indicator HyperthermInd Indicator of hyperthermia. Hyperthermia is defined as core temperature > 38 degrees Celsius Indicator of hyperthermia. Hyperthermia is defined as core temperature > 38 degrees Celsius Did participant/subject experience hyperthermia? Yes;No;Unknown;Suspected Yes;No;Unknown;Suspected Alphanumeric

Choose one. This element is recommended for pediatric studies. Second insults may aggravate processes of secondary damage in a brain already rendered vulnerable by the primary injury. The main physiologic insults relevant to TBI are hypotension, hyper- or hypothermia, hypoxia, and hypocapnia due to hyperventilation. The adverse effect of the occurrence of such insults both pre- and in-hospital is well established. Second insults are commonly defined by threshold values but these values are not well established in pediatrics. Based on the available data for pediatric TBI , thresholds of 80-180 mg/dL for glucose are recommended. A threshold for hemoglobin is more difficult to define given emerging data on the lower limit of hemoglobin safely tolerated by critically ill children in general and the variable effect of blood transfusion in children with severe TBI specifically.

McHugh GS, Engel DC, Butcher I, et al. Prognostic value of secondary insults in traumatic brain injury: results from the IMPACT study. J Neurotrauma. Feb 2007;24(2):287-93. Signorini DF, Andrews PJ, Jones PA, et al. Adding insult to injury: the prognostic value of early secondary insults for survival after traumatic brain injury. J Neurol Neurosurg Psychiatry. Jan 1999;66(1):26-31 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. uidelines 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 3.00 2013-07-20 10:21:25.65 Second Insults and Other Complications Second Insults Disease/Injury Related Events

Single Pre-Defined Value Selected

C05457 Hypoxic episode indicator HypxEpiInd Indicator of hypoxic episode. Hypoxic episode is defined as partial pressure of oxygen in the blood (paO2) < 8kPa (60mmHg) or oxygen saturation (SaO2) < 90% Indicator of hypoxic episode. Hypoxic episode is defined as partial pressure of oxygen in the blood (paO2) < 8kPa (60mmHg) or oxygen saturation (SaO2) < 90% Did participant/subject experience hypoxic episode? Yes;No;Unknown;Suspected Yes;No;Unknown;Suspected Alphanumeric

Choose one.

McHugh GS, Engel DC, Butcher I, et al. Prognostic value of secondary insults in traumatic brain injury: results from the IMPACT study. J Neurotrauma. Feb 2007;24(2):287-93. Silverstone P. Pulse oxymetry of at the road side: a study of pulse oxymetry in immediate care. BMJ. Mar 1989;298(6675):711-13. Stocchetti N, Furlan A, Volta F. Hypoxemia and arterial hypotension at the accident side in head injury. J Trauma. 1996;40:764-67. De Witt DS, Jenkins LW, Prough DS. Enhanced vulnerability to secondary ischemic insults after experimental traumatic brain injury. New Horizon. Aug 1995;3(3):376-383. Steyerberg EW, Mushkudiani N, Perel P, et al. Predicting outcome after traumatic brain injury: development and international validation of prognostic scores based on admission characteristics. PLoS Med. Aug 2008;5(8):e165. MRC CRASH Trial Collaborators. Predicting outcome after traumatic brain injury: practical prognostic models based on large cohort of international patients. BMJ. Feb 2008;336(7641):425-429. Signorini DF, Andrews PJ, Jones PA, et al. Adding insult to injury: the prognostic value of early secondary insults for survival after traumatic brain injury. J Neurol Neurosurg Psychiatry. Jan 1999;66(1):26-31 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 3.00 2013-07-20 10:21:25.65 Second Insults and Other Complications Second Insults Disease/Injury Related Events

Single Pre-Defined Value Selected

C05458 Inadvertent hypocapnia indicator InadvertHypocapniaInd Indicator of inadvertent hypocapnia episode. Inadvertent hypocapnia is defined as the partial pressure of carbon dioxide in the blood (paCo2) <= 25 mmHg (3.3 kPa), not deliberately employed to treat elevated intracranial pressure Indicator of inadvertent hypocapnia episode. Inadvertent hypocapnia is defined as the partial pressure of carbon dioxide in the blood (paCo2) <= 25 mmHg (3.3 kPa), not deliberately employed to treat elevated intracranial pressure Did participant/subject experience an inadvertent hypocapnia episode? Yes;No;Unknown;Suspected Yes;No;Unknown;Suspected Alphanumeric

Choose one. Response obtained from medical charts and/or patient data management system. Add date stamp for when assessed. Recommend collection at least during initial medical treatment. Many types of second insults may occur in the in-hospital situation, both systemic and intracranial. Systemic second insults may for example also include episodes of hypoglaecemia, hyponatremia, hypernatremia, hyperthermia and many more. We chose to recommend to document the clinically most relevant and frequently occurring second insults: hypoxia, hypotension, inadvertent hypocapnia and seizure activity. Hypoxia, hypotension and inadvertent hypocapnia are the most frequent causes of jugular desaturations, and periods of low brain tissue oxygen tension. The depth and duration of systemic second insults during the clinical course is related to poorer outcome. In the intensive care environment with continuous monitoring, accurate detection of the number and duration of episodes of second insults should be possible. Thus permitting an accurate documentation of the number, depth and duration of these insults individually and summated per insult over a given period. Unfortunately, most commercially available monitoring systems do not include dedicated software to facilitate this approach. We therefore recommend to simply document the occurrence of second insults, differentiating single episodes of short duration from multiple episodes or those of more prolonged duration, as these latter may have more profound effects in aggravating secondary brain damage. Pediatric-specific notes: Second insults are commonly defined by threshold values but these values are not well established in pediatrics. Based on the available data for pediatric TBI , thresholds of 80-180 mg/dL for glucose are recommended. A threshold for hemoglobin is more difficult to define given emerging data on the lower limit of hemoglobin safely tolerated by critically ill children in general and the variable effect of blood transfusion in children with severe TBI specifically.

McHugh GS, Engel DC, Butcher I, et al. Prognostic value of secondary insults in traumatic brain injury: results from the IMPACT study. J Neurotrauma. Feb 2007;24(2):287-93. Signorini DF, Andrews PJ, Jones PA, et al. Adding insult to injury: the prognostic value of early secondary insults for survival after traumatic brain injury. J Neurol Neurosurg Psychiatry. Jan 1999;66(1):26-31 Pediatric reference: 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. uidelines 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 3.00 2013-07-20 10:21:25.65 Second Insults and Other Complications Second Insults Disease/Injury Related Events

Single Pre-Defined Value Selected

C05459 Cardiac arrest indicator CardArrestInd Indicator of cardiac arrest requiring cardiopulmonary resuscitation (i.e. at least two minutes of chest compressions). Cardiac arrest is a condition in which the heart suddenly and unexpectedly stops beating Indicator of cardiac arrest requiring cardiopulmonary resuscitation (i.e. at least two minutes of chest compressions). Cardiac arrest is a condition in which the heart suddenly and unexpectedly stops beating Did participant/subject expierence cardiac arrest? Yes;No;Suspected;Unknown Yes;No;Suspected;Unknown Alphanumeric

Choose one. This element is recommended for pediatric studies. Second insults may aggravate processes of secondary damage in a brain already rendered vulnerable by the primary injury. The main physiologic insults relevant to TBI are hypotension, hyper- or hypothermia, hypoxia, and hypocapnia due to hyperventilation. The adverse effect of the occurrence of such insults both pre- and in-hospital is well established. Second insults are commonly defined by threshold values but these values are not well established in pediatrics. Based on the available data for pediatric TBI , thresholds of 80-180 mg/dL for glucose are recommended. A threshold for hemoglobin is more difficult to define given emerging data on the lower limit of hemoglobin safely tolerated by critically ill children in general and the variable effect of blood transfusion in children with severe TBI specifically.

McHugh GS, Engel DC, Butcher I, et al. Prognostic value of secondary insults in traumatic brain injury: results from the IMPACT study. J Neurotrauma. Feb 2007;24(2):287-93. Signorini DF, Andrews PJ, Jones PA, et al. Adding insult to injury: the prognostic value of early secondary insults for survival after traumatic brain injury. J Neurol Neurosurg Psychiatry. Jan 1999;66(1):26-31 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. uidelines 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 3.00 2013-07-20 10:21:25.65 Second Insults and Other Complications Second Insults Disease/Injury Related Events

Single Pre-Defined Value Selected

CSV