This form structure is an organized set of data definitions for a form that has not been copyrighted

 General Details

Title:
Second Insults and Other Complications
Short Name:
SecInsultsOtherComplctns
Description:
Contains data elements that are collected to describe insults and complications the participant/subject experienced secondary to the injury.
Disease:
Traumatic Brain Injury
Organization:
NINDS
Required Program Form:
No
Standardization:
Standard NINDS CDE
Labels:
Form Type:
Clinical Assessment
Publication Date:
2019-03-11
Version:
1.0
Date Created:
2016-08-26
Owner:
Number of Data Elements:
26
eForms:
N

 Documentation


 Groups & Attached Data Elements

Logically grouped data elements with defined frequency at which they repeat.

# Title Short Description Variable Name Required? Type
1 GUID   Global Unique ID which uniquely identifies a subject GUID Required CDE
2 Subject identifier number   An identification number assigned to the participant/subject within a given protocol or a study. SubjectIDNum Recommended CDE
3 Age in years   Value for participant's subject age recorded in years. AgeYrs Recommended CDE
4 Vital status   Status of participant/subject as alive or dead VitStatus Recommended CDE
5 Visit date   Actual interview or visit date VisitDate Recommended CDE
6 Site name   The name of the site for the study SiteName Optional CDE
7 Days since baseline   The number of days since baseline DaysSinceBaseline Optional CDE
8 Case control indicator   Indicator of whether subject is in the case or control arm of the study CaseContrlInd Optional CDE
9 General notes text   General notes GeneralNotesTxt Optional CDE

Additional Element Groups

Listed below are your additional element groups.

Form Adminstration (Appears Up To 1 Time)

# Title Short Description Variable Name Required? Type
1 Context type  The context to which the questions were answered ContextType Recommended CDE
2 Context type other text  The free-text related to ContextType specifying other text ContextTypeOTH Recommended CDE
3 Data source  Source of the data provided on the case report form DataSource Recommended CDE
4 Data source other text  The free-text field related to Data source specifying other text. Source of the data provided on the case report form DataSourceOTH Recommended CDE

Second Insults and Other Complications (Appears Up To 1 Time)

# Title Short Description Variable Name Required? Type
1 Hypotensive episode indicator  Indicator of hypotensive episode. In adults, hypotensive episode is defined as systolic blood pressure & less than ; 90 mmHg. In children, it is defined as systolic blood pressure & less than ; 5th percentile for age HypotnsnEpiInd Recommended CDE
2 Hypoxic episode indicator  Indicator of hypoxic episode. Hypoxic episode is defined as partial pressure of oxygen in the blood (paO2) less than 8kPa (60mmHg) or oxygen saturation (SaO2) less than 90% HypxEpiInd Recommended CDE
3 Cardiac arrest indicator  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 CardArrestInd Recommended CDE
4 Seizure indicator  Indicator of seizure activity SeizInd Recommended CDE
5 Seizure presentation type  Type of seizure activity as convulsive or non-convulsive (diagnosed on EEG only, no motor manifestations) SeizPresentTyp Recommended CDE

Additional Supplemental Elements (Appears Up To 1 Time)

# Title Short Description Variable Name Required? Type
1 Hypertension indicator  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 HypertensInd Optional CDE
2 Hypothermia indicator  Indicator of hypothermia. Hypothermia is defined as core temperature 35 degrees Celsius HypothermInd Optional CDE
3 Hyperthermia indicator  Indicator of hyperthermia. Hyperthermia is defined as core temperature > 38 degrees Celsius HyperthermInd Optional CDE
4 Inadvertent hypocapnia indicator  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 InadvertHypocapniaInd Optional CDE
5 Seizure duration type  Seizure described as intermittent or status epilepticus. Status epilepticus is defined as either 2 or more convulsions without complete recovery of consciousness between seizures or as a single prolonged seizure that lasts for at least 30 minutes. SeizDurType Optional CDE
6 EEG monitoring type  Type of electroencephalogram (EEG) monitoring EEGMonitorType Optional CDE
7 Hyperventilation indicator  Indicator of hyperventilation. Hyperventilation is defined as rapid, deep breathing, possibly exceeding 40 breaths/minute HyperventInd Optional CDE
8 Aspiration indicator  Indicator of foreign material breathed into the airway AspiratnInd Optional CDE

 Change History

 Administrative Change History