Trial Outcomes & Findings for Near-Infrared Spectroscopy for Pediatric Acute Scrotum and Testicular Torsion (NCT NCT01812109)

NCT ID: NCT01812109

Last Updated: 2024-05-24

Results Overview

Testicular tissue percent oxygen saturation (%StO2) is measured by transscrotal near infrared spectroscopy (NIRS). This is similar to the PulseOx machine that is usually used when we go for a regular doctor visit. NIRS measurements were obtained with Hutchison Technology InSpectra StO2 Spot Check Device (Model 300) with thenar clip probe (Model 1315, modified by clip removal). Measurements were done at 1, 5 and 10 seconds to account for interassay variability, which is expected to be less than 3 %StO2. The average of the 3 readings was defined as the NIRS %StO2 reading for that testis. The NIRS readings in the affected testis were normalized to the contralateral normal testis to formulate a NIRS delta %StO2 (%StO2 of unaffected testis and %StO2 of affected testis). If the affected testis had lower %StO2 readings than the contralateral normal testis, NIRS delta %StO2 would be positive.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 154 participants
• Primary outcome timeframe: Done at 1, 5 and 10 seconds
• Results posted on: 2024-05-24

Participant Flow

Participant milestones

Measure	NIRS There is only 1 group in this non randomized pilot study. Those patients with acute scrotum defined as painful scrotum or testes, abdominal pain +/- nausea and vomiting, waddling gain (cowboy shuffle) .
Overall Study STARTED	154
Overall Study With Torsion	36
Overall Study Without Torsion	85
Overall Study COMPLETED	121
Overall Study NOT COMPLETED	33

Reasons for withdrawal

Measure	NIRS There is only 1 group in this non randomized pilot study. Those patients with acute scrotum defined as painful scrotum or testes, abdominal pain +/- nausea and vomiting, waddling gain (cowboy shuffle) .
Overall Study research personnel delay	16
Overall Study NIRS Unattainable	17

Baseline Characteristics

Near-Infrared Spectroscopy for Pediatric Acute Scrotum and Testicular Torsion

Baseline characteristics by cohort

Measure	NIRS n=121 Participants There is only 1 group in this non randomized pilot study. Those patients with acute scrotum defined as painful scrotum or testes, abdominal pain +/- nausea and vomiting, waddling gain (cowboy shuffle) .
Age, Continuous	11.8 years STANDARD_DEVIATION 3.8 • n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants
Sex: Female, Male Male	121 Participants n=5 Participants
Race/Ethnicity, Customized White	23 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic	79 Participants n=5 Participants
Race/Ethnicity, Customized Black	15 Participants n=5 Participants
Race/Ethnicity, Customized Asian	1 Participants n=5 Participants
Race/Ethnicity, Customized Other	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: Done at 1, 5 and 10 seconds

Population: Here we are reporting Median NIRS delta %StO2 with Torsion and without torsion.

Testicular tissue percent oxygen saturation (%StO2) is measured by transscrotal near infrared spectroscopy (NIRS). This is similar to the PulseOx machine that is usually used when we go for a regular doctor visit.

NIRS measurements were obtained with Hutchison Technology InSpectra StO2 Spot Check Device (Model 300) with thenar clip probe (Model 1315, modified by clip removal).

Measurements were done at 1, 5 and 10 seconds to account for interassay variability, which is expected to be less than 3 %StO2. The average of the 3 readings was defined as the NIRS %StO2 reading for that testis. The NIRS readings in the affected testis were normalized to the contralateral normal testis to formulate a NIRS delta %StO2 (%StO2 of unaffected testis and %StO2 of affected testis). If the affected testis had lower %StO2 readings than the contralateral normal testis, NIRS delta %StO2 would be positive.

Outcome measures

Measure	Hutchison Technologies Inspectra StO2 NIRS n=121 Participants Hutchison Technologies Inspectra StO2 SpotCheck Near-Infrared Spectroscopy (NIRS) evaluation of acute scrotum per protocol Hutchison Technologies Inspectra StO2 SpotCheck Near-Infrared Spectroscopy: Device: Near-Infrared Spectroscopy Transscrotal NIRS is a series of 6 transcutaneous scrotal measurements, 3 on both left/right. Each measurement is completely non-invasive, painless and takes \~15 seconds each. Thus, no sedation or supplemental analgesia is needed for NIRS. The NIRS probe will be placed on the anterior, lateral and posterior scrotum on the left/right sides, immediately overlying and parallel to the long axis of the testis but on the skin to obtain the 6 total measurements. The unaffected testis will serve as the patient's own control. Study coordinators will be performing the ER transscrotal NIRS testing. For uniformity, all will be trained for testicular probe placement methods. NIRS will not delay the gray scale/color Doppler testicular US or surgery.
Median NIRS Delta %StO2 Torsion	2.0 percentage of StO2 Interval -4.2 to 9.8
Median NIRS Delta %StO2 No Torsion	-1.7 percentage of StO2 Interval -8.7 to 2.0

Adverse Events

Hutchison Technologies Inspectra StO2 NIRS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Linda Baker

University of Texas Southwestern Medical Center

Phone: 214/456-2480

Email: Linda.baker@childrens.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place