CDE Detailed Report

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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
C01557 Respiratory support type RespSuppTyp Type of respiratory support participant/subject received Type of respiratory support participant/subject received Respiratory support type: Bag mask ventilation (BMV);Intubation;CPAP;BiPAP;No support needed;Oral airway Bag mask ventilation (BMV);Intubation;CPAP (Continuous positive airway pressure);BiPAP (bilevel positive airway pressure);No support needed;Oral airway Alphanumeric

Choose all that apply. Recommend collection immediately upon arrival in the ER, prior to resuscitation therapy.

No references available Adult;Pediatric Supplemental 3.00 2013-07-20 10:21:25.65 Vital Signs and Blood Gases [php] [php_1]

Multiple Pre-Defined Values Selected

C01510 Blood pressure systolic mean daily measurement BloodPressSystMeanDayMeasr Mean measurement of the participant's/subject's systolic blood pressure over a 24-hour period Mean measurement of the participant's/subject's systolic blood pressure over a 24-hour period Mean daily blood pressure Numeric Values

(Systolic)
The suggested range is 0-300 mmHg.

No references available Adult;Pediatric Supplemental 3.00 2013-07-20 10:21:25.65 Vital Signs and Blood Gases [php] [php_1]

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0 300 millimeter of mercury
C01558 Partial pressure oxygen brain tissue measurement PPO2BrainTissMeasr Measurement of how much oxygen is dissolved in the brain tissue (PbtO2) Measurement of how much oxygen is dissolved in the brain tissue (PbtO2) Partial pressure of oxygen in brain tissue Numeric Values

Capture in millimeters of mercury (mmHg)

No references available Adult;Pediatric Supplemental 5.00 2017-01-25 11:38:25.0 Vital Signs and Blood Gases [php] [php_1]

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0 300
C01518 Circulation support type CircSuppTyp Therapies or procedures the participant/subject received to support circulation Therapies or procedures the participant/subject received to support circulation Types of circulation support No specific therapy;IV fluids - Crystalloids;IV fluids - Hypertonic saline;IV fluids - Colloids;IV fluids - Blood;Vasopressors;CPR;Ventricular assistive device;Other;Unknown No specific therapy;IV fluids - Crystalloids;IV fluids - Hypertonic saline;IV fluids - Colloids;IV fluids - Blood;Vasopressors;CPR;Ventricular assistive device;Other;Unknown Alphanumeric

Choose all that apply. Assess (and document later) the ABC status immediately upon arrival in the ER, prior to resuscitation therapy. Problems with the ABC status may cause substantial second insults (hypoxia and hypotension), exacerbating the brain injury in TBI.

Murray GD, Butcher I, McHugh GS, et al. Multivariable prognostic analysis in traumatic brain injury: results from the IMPACT study. J Neurotrauma. Feb 2007;24(2):329-337. Brain Trauma Foundation, American Association of Neurological Surgeons (AANS), Congress of Neurological Surgeons (CNS), AANS/CNS Joint Section on Neurotrauma and Critical Care: Guidelines for the management of severe traumatic brain injury. I. Blood pressure and oxygenation. J Neurotrauma. 2007;24 (Suppl 1):S7-S13. Adult;Pediatric Supplemental 3.00 2013-07-20 10:21:25.65 Vital Signs and Blood Gases [php] [php_1]

Multiple Pre-Defined Values Selected

C01559 Arterial partial pressure carbon dioxide value ArterialPPCO2Val Measurement of how much carbon dioxide is dissolved in the arterial blood and how well carbon dioxide is able to move out of the body (PaCO2) Measurement of how much carbon dioxide is dissolved in the arterial blood and how well carbon dioxide is able to move out of the body (PaCO2) Partial pressure of carbon dioxide in aterial vessles Numeric Values

The suggested range is 0-99 mmHg or 0-13.2 kPa. Recommended for collection on admission and daily as required by protocol.

No references available Adult;Pediatric Supplemental 3.00 2013-07-20 10:21:25.65 Vital Signs and Blood Gases [php] [php_1]

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0 100 millimeter of mercury
C01521 Heart rate HeartRate The participant's pulse or number of contractions (heart beats) per minute The participant's pulse or number of contractions (heart beats) per minute Heart rate beats per minute Numeric Values

Record heart rate from monitor or by counting pulse rate. The suggested range is 0-300. Add date stamp for when assessed. Heart rate may be altered by trauma in a couple of ways. Tachycardia may indicate volume depletion, pain or stress, and higher heart rates have been found in patients that do not survive traumatic injuries. Bradycardia may be seen with elevated intracranial pressure. 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 basic 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).

Shoemaker WC, Bayard DS, Botnen A, et al. Mathematical program for outcome prediction and therapeutic support for trauma beginning within 1 hr of admission: a preliminary report. Crit Care Med. Jul 2005;33(7):1499-1506. Agrawal A, Timothy J, Cincu R, et al. Bradycardia in neurosurgery. Clin Neurol Neurosurg. Apr 2008;110(4):321-7. Adult;Pediatric Supplemental 3.10 2024-03-11 10:48:30.0 Vital Signs and Blood Gases [php] [php_1]

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0 300 beats per minute 2767073
C01560 Arterial partial pressure oxygen value ArterialPPO2Val Measurement of how much oxygen is dissolved in the arterial blood and how well oxygen is able to move from the airspace of the lungs into the blood (PaO2) Measurement of how much oxygen is dissolved in the arterial blood and how well oxygen is able to move from the airspace of the lungs into the blood (PaO2) Partial pressure of oxygen in arterial vessles (%) Numeric Values

The suggested range is 0-650 mmHg or 0-86.5 kPa. Recommended for collection on admission and daily as required by protocol.

No references available Adult;Pediatric Supplemental 3.00 2013-07-20 10:21:25.65 Vital Signs and Blood Gases [php] [php_1]

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C01530 Arterial partial pressure oxygen mean daily value ArterialPPO2MeanDailyVal Mean measurement of the partial pressure of oxygen (PaO2) over a 24-hour period. PaO2 is the pressure of oxygen dissolved in the blood and how well oxygen is able to move from the airspace of the lungs into the blood Mean measurement of the partial pressure of oxygen (PaO2) over a 24-hour period. PaO2 is the pressure of oxygen dissolved in the blood and how well oxygen is able to move from the airspace of the lungs into the bloo Mean measurement of the arterial partial pressure of oxygen Numeric Values

The suggested range is 0-650 mmHg or 0-86.5 kPa. Recommended for collection on admission and daily as required by protocol.

No references available Adult;Pediatric Supplemental 3.00 2013-07-20 10:21:25.65 Vital Signs and Blood Gases [php] [php_1]

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C01565 Blood pressure systolic measurement BldPressrSystMeasr Measurement of pressure of the participant's blood against the artery walls during systole (the contraction phase) in millimeters of mercury (mmHg) Measurement of pressure of the participant's blood against the artery walls during systole (the contraction phase) in millimeters of mercury (mmHg) Blood pressure Numeric Values

Record blood pressure from the blood pressure monitor or measure manually by sphygmanometry. The suggested range is 0-300 mmHg. Add date stamp for when assessed.When hourly values are documented, we recommend to take readings at a fixed time point, for example the last minute of the hour. Exclude values which may be influenced by artifacts. The injured brain is often not able to pressure autoregulate normally, adequate perfusion may be more dependent on perfusion pressure; lower blood pressure and low perfusion pressure can aggravate ischemic damage to the injured brain whilst conversely a high blood pressure may lead to increased intracranial pressure and carries an increased risk of neurogenic lung edema. Hypotensive episodes before and after admission adversely affect outcome. In patients with severe traumatic brain injury, routine calculation of the cerebral perfusion pressure on an hourly basis is recommended. Pediatric-specific notes: This element is recommended for pediatric studies. As a minimum, vital signs should be recorded on admission and further, on a daily basis during the acute phase after injury. For the basic 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).

Management and prognosis of severe traumatic brain injury, J Neurotrauma 2000;17:591-595. Butcher I, Maas AI, Lu J , et al. Prognostic value of admission blood pressure in traumatic brain injury: results from the IMPACT study. J Neurotrauma. Feb 2007;24(2):294-302. Murray GD, Butcher I, McHugh GS, et al. Multivariate prognostic analysis in traumatic brain injury. J Neurotrauma. Feb 2007;24(2):329-377. Adult;Pediatric Supplemental 3.10 2024-03-11 10:40:09.0 Vital Signs and Blood Gases [php] [php_1]

Free-Form Entry

0 300 millimeter of mercury 2004289 C25298
C01531 Arterial partial pressure carbon dioxide mean daily value ArterialPPCO2MeanDailyVal Mean measurement of the arterial partial pressure of carbon dioxide (PCO2) over a 24-hour period. PCO2 is the measurement of how much carbon dioxide is dissolved in the arterial blood and how well carbon dioxide is able to move out of the body Mean measurement of the arterial partial pressure of carbon dioxide (PCO2) over a 24-hour period. PCO2 is the measurement of how much carbon dioxide is dissolved in the arterial blood and how well carbon dioxide is able to move out of the bod Mean measurement of the arterial partial pressure of carbon dioxide Numeric Values

The suggested range is 0-99 mmHg or 0-13.2 kPa. Recommended for collection on admission and daily as required by protocol.

No references available Adult;Pediatric Supplemental 3.00 2013-07-20 10:21:25.65 Vital Signs and Blood Gases [php] [php_1]

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C18408 Blood gases pressure unit of measure BldGasPresMeasrUnit Unit of measure for the pressure of blood gases (i.e. O2 , CO2) in the blood stream (i.e. arterial, venous) Unit of measure for the pressure of blood gases (i.e. O2 , CO2) in the blood stream (i.e. arterial, venous) Unit of measure for blood gases (O2, CO2) mmHg;kPa mmHg (milimeter of mercury);kPa (kilopascal) Alphanumeric No references available Adult;Pediatric Supplemental 3.00 2013-07-20 10:21:25.65 Vital Signs and Blood Gases [php] [php_1]

Single Pre-Defined Value Selected

C01532 Oxygen saturation mean daily measurement O2SaturMeanDailyMeasr Value of the mean of the participant's/subject's oxygen saturation over a 24-hour period Value of the mean of the participant's/subject's oxygen saturation over a 24-hour perio Mean oxygen saturation Numeric Values

The suggested range is 0-100. Add date stamp for when assessed. Recommended for collection on admission and daily as required by protocol. 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 basic 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).

No references available Adult;Pediatric Supplemental 3.00 2013-07-20 10:21:25.65 Vital Signs and Blood Gases [php] [php_1]

Free-Form Entry

0 100 percent
C01534 Oxygen saturation minimum daily value O2SaturMinDailyVal Lowest measurement of the participant's/subject's oxygen saturation over the 24-hour period Lowest measurement of the participant's/subject's oxygen saturation over the 24-hour perio Daily minimum value of oxygen saturation (%) Numeric Values

The suggested range is 0-100. Add date stamp for when assessed. Recommended for collection on admission and daily as required by protocol.

No references available Adult;Pediatric Supplemental 3.00 2013-07-20 10:21:25.65 Vital Signs and Blood Gases [php] [php_1]

Free-Form Entry

0 100 percent
C01535 Respiratory rate RespRate Rate of the participant's breathing (inhalation and exhalation) Rate of the participant's breathing (inhalation and exhalation) Respiratory rate in breaths per minute Numeric Values

Add date stamp for when assessed. Hypoxia, hypercapnia, and hypocapnia have all been associated with poor outcome.

Davis, DP. Early ventilation in traumatic brain injury. Resuscitation. Mar 2008;76(3):333-340. Guidelines for the management of severe traumatic brain injury. XIV. Hyperventilation. J Neurotrauma. 2008;25:276-8. Murray GD, Butcher I, McHugh GS, et al. Multivariable prognostic analysis in traumatic brain injury: results from the IMPACT study. J Neurotrauma. Feb 2007;24(2):329-337. Adult;Pediatric Supplemental 3.10 2024-03-11 10:50:02.0 Vital Signs and Blood Gases [php] [php_1]

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0 120 breaths per minute 2644399
C01551 Respiration type RespTyp Type of respiration. Type of respiration. Type of respiration Spontaneous;Ventilated;Apneic;Unknown Spontaneous;Ventilated;Apneic;Unknown Alphanumeric

Choose one. This is especially relevant to collect at the time respiratory rate is measured. When recording respiratory rate, we consider it essential to link the rate to the type of ventilation (spontaneous or ventilated) at the same time. Hypoxia, hypercapnia, and hypocapnia have all been associated with poor outcome.

Davis, DP. Early ventilation in traumatic brain injury. Resuscitation. Mar 2008;76(3):333-340. Guidelines for the management of severe traumatic brain injury. XIV. Hyperventilation. J Neurotrauma. 2008;25:276-8. Murray GD, Butcher I, McHugh GS, et al. Multivariable prognostic analysis in traumatic brain injury: results from the IMPACT study. J Neurotrauma. Feb 2007;24(2):329-337. Adult;Pediatric Supplemental 3.00 2013-07-20 10:21:25.65 Vital Signs and Blood Gases [php] [php_1]

Single Pre-Defined Value Selected

C01502 Blood pressure diastolic mean daily measurement BloodPressDiastMeanDayMeasr Mean measurement of the participant's/subject's diastolic blood pressure over a 24-hour period Mean measurement of the participant's/subject's diastolic blood pressure over a 24-hour period Mean daily blood pressure Numeric Values

(Diastolic)
The suggested range is 0-300 mmHg.

No references available Adult;Pediatric Supplemental 3.00 2013-07-20 10:21:25.65 Vital Signs and Blood Gases [php] [php_1]

Free-Form Entry

millimeter of mercury
C01554 Oxygen saturation measurement O2SatMeasr Value, as a percent, of baseline O2 saturation (SPO2) in nocturnal oximetry, as part of Nocturnal Oximetry Value, as a percent, of baseline O2 saturation (SPO2) in nocturnal oximetry, as part of Nocturnal Oximetr Oxygen saturation (%) Numeric Values

The suggested range is 0-100. Add date stamp for when assessed. Recommended for collection on admission and daily as required by protocol.

No references available Adult;Pediatric Supplemental 3.00 2013-07-22 16:57:17.79 Vital Signs and Blood Gases [php] [php_1]

Free-Form Entry

0 100 percent
C01507 Blood pressure diastolic measurement BldPressrDiastlMeasr Measurement of pressure of the participant's blood against the artery walls during diastole (the relaxation phase) in millimeters of mercury (mmHg) Measurement of pressure of the participant's blood against the artery walls during diastole (the relaxation phase) in millimeters of mercury (mmHg) Blood pressure Numeric Values

Record blood pressure from the blood pressure monitor or measure manually by sphygmanometry. The suggested range is 0-300 mmHg. Add date stamp for when assessed.When hourly values are documented, we recommend to take readings at a fixed time point, for example the last minute of the hour. Exclude values which may be influenced by artifacts. Add date stamp for when assessed. The injured brain is often not able to pressure autoregulate normally, adequate perfusion may be more dependent on perfusion pressure; lower blood pressure and low perfusion pressure can aggravate ischemic damage to the injured brain whilst conversely a high blood pressure may lead to increased intracranial pressure and carries an increased risk of neurogenic lung edema. Hypotensive episodes before and after admission adversely affect outcome. In patients with severe traumatic brain injury, routine calculation of the cerebral perfusion pressure on an hourly basis is recommended. 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).

Management and prognosis of severe traumatic brain injury, J Neurotrauma 2000;17:591-595.; Butcher I, Maas AI, Lu J , et al. Prognostic value of admission blood pressure in traumatic brain injury: results from the IMPACT study. J Neurotrauma. Feb 2007;24(2):294-302.; Murray GD, Butcher I, McHugh GS, et al. Multivariate prognostic analysis in traumatic brain injury. J Neurotrauma. Feb 2007;24(2):329-377. Adult;Pediatric Supplemental 3.10 2024-03-11 10:40:54.0 Vital Signs and Blood Gases [php] [php_1]

Free-Form Entry

0 300 millimeter of mercury 2004291
CSV