Sub-Domain: Assessments and Examinations
CRF: Vital Signs and Blood Gases
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 | Source | Form Set | Form | Field | Domain | CDASH Variable | CDASH Definition | CDASH Label | Controlled Terminology | Prompt | Essentiality | Question Text | CDASH imp guidance | SDTM IG target | csDSR | PhenX | Data Type | CRF Completion Inst | SDTMIG Target Var | SDTMIG Target Map | Codelist Name | PVs | Pre Pop Value | Query Display | List Style |
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C01535 | Respiratory rate | RespRate | Rate of the participant/subject's breathing (inhalation and exhalation). | Rate of the participant/subject'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 | Core | 3.00 | 2013-08-28 16:08:00.453 | Vital Signs and Blood Gases | Assessments and Examinations | Vital Signs and Other Body Measures |
Free-Form Entry |
0 | 120 | breaths per minute | 2644399 | DeBaun Forms | ||||||||||||||||||||||||||
C01551 | Respiration type | RespTyp | Type of respiration. | Type of respiration. This is especially relevant to collect at the time respiratory rate is measured. | 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 | Assessments and Examinations | Vital Signs and Other Body Measures |
Single Pre-Defined Value Selected |
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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) |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-07-20 10:21:25.65 | Vital Signs and Blood Gases | Assessments and Examinations | Vital Signs and Other Body Measures |
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 Oximetry. | 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 | Core | 3.00 | 2013-07-22 16:57:17.79 | Vital Signs and Blood Gases | Assessments and Examinations | Vital Signs and Other Body Measures |
Free-Form Entry |
0 | 100 | percent | DeBaun Forms | |||||||||||||||||||||||||||
C01507 | Blood pressure diastolic measurement | BldPressrDiastlMeasr | Measurement of pressure of the participant's/subject's blood against the artery walls during diastole (the relaxation phase) in millimeters of mercury (mmHg) | Measurement of pressure of the participant's/subject'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 | Core | 3.00 | 2013-07-25 08:54:08.2 | Vital Signs and Blood Gases | Assessments and Examinations | Vital Signs and Other Body Measures |
Free-Form Entry |
0 | 300 | millimeter of mercury | 2004291 | DeBaun Forms | ||||||||||||||||||||||||||
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;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;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 | Assessments and Examinations | Vital Signs and Other Body Measures |
Multiple Pre-Defined Values Selected |
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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) |
No references available | Adult;Pediatric | Supplemental | 3.00 | 2013-07-20 10:21:25.65 | Vital Signs and Blood Gases | Assessments and Examinations | Vital Signs and Other Body Measures |
Free-Form Entry |
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 | Assessments and Examinations | Vital Signs and Other Body Measures |
Free-Form Entry |
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 | Assessments and Examinations | Vital Signs and Other Body Measures |
Multiple Pre-Defined Values Selected |
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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 | Assessments and Examinations | Vital Signs and Other Body Measures |
Free-Form Entry |
0 | 100 | millimeter of mercury | ||||||||||||||||||||||||||||
C01521 | Heart rate | HeartRate | The participant/subject's pulse or number of contractions (heart beats) per minute | The participant/subject'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 | Core | 3.00 | 2013-08-28 16:08:00.453 | Vital Signs and Blood Gases | Assessments and Examinations | Vital Signs and Other Body Measures |
Free-Form Entry |
0 | 300 | beats per minute | 2767073 | DeBaun Forms | ||||||||||||||||||||||||||
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 | Assessments and Examinations | Vital Signs and Other Body Measures |
Free-Form Entry |
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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 blood. | 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 | Assessments and Examinations | Vital Signs and Other Body Measures |
Free-Form Entry |
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C01565 | Blood pressure systolic measurement | BldPressrSystMeasr | Measurement of pressure of the participant's/subject's blood against the artery walls during systole (the contraction phase) in millimeters of mercury (mmHg) | Measurement of pressure of the participant's/subject'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 | Core | 3.00 | 2013-07-25 08:54:08.2 | Vital Signs and Blood Gases | Assessments and Examinations | Vital Signs and Other Body Measures |
Free-Form Entry |
0 | 300 | millimeter of mercury | 2004289 | DeBaun Forms | ||||||||||||||||||||||||||
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 body. | 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 | Assessments and Examinations | Vital Signs and Other Body Measures |
Free-Form Entry |
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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 | Assessments and Examinations | Vital Signs and Other Body Measures |
Single Pre-Defined Value Selected |
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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 period. | 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 | Assessments and Examinations | Vital Signs and Other Body Measures |
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 period. | 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 | Assessments and Examinations | Vital Signs and Other Body Measures |
Free-Form Entry |
0 | 100 | percent |