Near Infrared Spectroscopy and Testicular Torsion in Children

NIRS estimates tissue saturation of oxygenation in tissue beds. Animals studies suggested that transscrotal NIRS measurements can quantify testicular hypoxia and differentiate between torsed and non torsed testicles. The results of human studies are not conclusive. The hypothesis is that the difference in NIRS values between torsed and healthy testicles would not be zero and that this difference would be zero in control group and that NIRS could help to detect rapidly a TT Testicular torsion (TT) is a functional emergency. The diagnosis is sometimes difficult to make. No paraclinical examination can eliminate it with certainty. The investigators aimed to evaluate the interest of transscrotal near-infrared spectroscopy (NIRS) for the diagnosis of TT of child

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Key information

Conditions

Diagnostic Test Child Diagnosis Disease Genital Diseases Genital Diseases, Male Male Urogenital Diseases NIRS Pathologic Processes Pathological Conditions, Signs and Symptoms Spermatic Cord Torsion Testicular Torsion Urogenital Diseases

Age range

Up to 18 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

CHU Amiens

Amiens, 80054, France

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Step 1: healthy boys between 0 and 16 years old
Step 2Testicular pain group (Group 1 and 2): boy under 18 years, testicular pain

Exclusion criteria

cutaneous scrotal lesion,
fever (for the control group),
hypertension

Treatment and study plan

near-infrared spectroscopy (NIRS)

Other

NIRS measurements will be performed on each testicle on a group of healthy boys and on a group of boys under 18 years consulting to emergency for scrotal pain

Primary outcomes

mean tissue oxygenation percentage (NIRS measurements) of the testicles for healthy boys

Time frame: one day

Near-infrared spectroscopy (NIRS) is a noninvasive technology that continuously monitors regional tissue oxygenation. Originally used for assessment of oxygen saturation of the brain, its use has now been expanded to evaluation of oxygenation of tissues other than the brain.

Normal values for NIRS values are between 60-75% but physiological values of 55-60% have been reported in some cardiac patients
mean tissue oxygenation percentage (NIRS measurements) of the both testicles for boys with scrotal pain

Time frame: one day

Near-infrared spectroscopy (NIRS) is a noninvasive technology that continuously monitors regional tissue oxygenation. Originally used for assessment of oxygen saturation of the brain, its use has now been expanded to evaluation of oxygenation of tissues other than the brain.

Normal values for NIRS values are between 60-75% but physiological values of 55-60% have been reported in some cardiac patients
mean tissue oxygenation percentage (NIRS measurements) between both testicles for boys with scrotal pain

Time frame: one day

Near-infrared spectroscopy (NIRS) is a noninvasive technology that continuously monitors regional tissue oxygenation. Originally used for assessment of oxygen saturation of the brain, its use has now been expanded to evaluation of oxygenation of tissues other than the brain.

Normal values for NIRS values are between 60-75% but physiological values of 55-60% have been reported in some cardiac patients

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire, Amiens

Other

Registry information

Acronym: SPIRETTE

Important dates

Study start: 2020
Primary completion: 2022
Study completion: 2023
First posted: Mar 15, 2023
Registry last updated: Sep 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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