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. 2019 Feb 4;24(5):051411. doi: 10.1117/1.JBO.24.5.051411

Table 2.

Infrascanner clinical studies with children. The total number of patients is 578, and the total number of hematomas is 43.

Study Type Patients (N) Method of selection NIRS CT ICH Results
Robertson et al. (USA and India)19 Multicenter study (four centers in USA and one in India) 36 Admitted to emergency room with TBI and were sent for a head CT Model 1000
Evaluated within 40 min of CT
All patients received CT 5 Sensitivity=100%
Specificity=93.5%
PPV=71.4%
NPV=100%
Coskun et al. (Turkey)21 Single center study 161 Admitted to emergency service with TBI Model 1000
Evaluated prior to CT. No repeats for positive results.
All patients received CT. 14 Sensitivity=85.7%
Specificity=65.3%
PPV=19.0%
NPV=98%
Salonia et al. (USA)18 Single center, prospective, case–control study 28 Patient underwent CT as part of clinical care, not necessarily triggered by trauma Model 1000
Evaluated within 24 h of CT
All 28 patients received CT 12 Sensitivity=100%
Specificity=81.3%
PPV=80%
NPV=100%
Bressan et al. (Italy)17 Dual center, prospective observational study 103 Minor head injury children presenting with intermediate or high risk for intracranial injury according to PECARN Model 1000 18
The rest were followed on the phone 7 to 90 days later to exclude initially missed hematoma.
1 Sensitivity=100%
Specificity=93.1%
PPV=12.5%
NPV=100%
Semenova et al. (Russia)14 Single center study 95 Presented with mild TBI (GCS 13 to 15) Model 1000 42 medium-high risk patients 8 Sensitivity=100%
Specificity=92%
PPV=53.3%
NPV=100%
Lewartowska-Nyga et al. (Poland)22 Single center study 155 Presenting with mild head injury (i.e., no focal or meningeal signs, and GCS score of 14 to 15) Model 1000
Evaluated up to 72 h postinjury
28
The rest were followed for 2 months’ postenrollment
3 Sensitivity=66.7%
Specificity=98.7%
PPV=50%
NPV=99.3%
Total   N=578       N=43 Sensitivity=93%
Specificity=86.5%