Near Infrared Spectroscopy and Testicular Torsion in Children

Child Clinical Trial

— SPIRETTE  

Official title:

Near Infrared Spectroscopy and Testicular Torsion in Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05769244
• Other study ID #: PI2019_843_0053
• Status: Completed
• Phase: N/A
• Start date: June 24, 2020
• Est. completion date: September 12, 2023

Study information

• Verified date: September 2023
• Source: Centre Hospitalier Universitaire, Amiens
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 55
• Est. completion date: September 12, 2023
• Est. primary completion date: June 24, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: N/A to 18 Years

Eligibility

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

Related Conditions & MeSH terms

• Child
• Diagnosis
• NIRS
• Spermatic Cord Torsion
• Testicular Torsion

Intervention

Other:
• near-infrared spectroscopy (NIRS)
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

Locations

Country	Name	City	State
France	CHU Amiens	Amiens

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire, Amiens

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean tissue oxygenation percentage (NIRS measurements) of the testicles for healthy boys	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	one day
Primary	mean tissue oxygenation percentage (NIRS measurements) of the both testicles for boys with scrotal pain	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	one day
Primary	mean tissue oxygenation percentage (NIRS measurements) between both testicles for boys with scrotal pain	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	one day