Infrared Thermography for Assessment of Caudal Block in Children

Anesthesia, Conduction Clinical Trial

Official title:

A Clinical Evaluation Of Infrared Thermography To Assess Successful Caudal Block In Children

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02907957
• Other study ID #: IRB 2016-590
• Status: Completed
• Phase: N/A
• Start date: September 2016
• Est. completion date: June 28, 2018

Study information

• Verified date: July 2018
• Source: Ann & Robert H Lurie Children's Hospital of Chicago
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Regional analgesia via caudal neuraxial blockade provides pain relief for pediatric patients following urological and lower extremity procedures. The injection of local anesthetic into the caudal epidural space causes a sensory loss. This sympathetic blockade in turn causes a vasodilation, or increased blood flow, to the lower extremities.

The purpose of this study is to determine whether the FLIR ONE thermographic camera, a smartphone attachment which utilizes an application ("app") to measure the temperature at a site on an image of the lower extremity, will be able to differentiate between caudal, non-caudal, and failed caudal images.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: June 28, 2018
• Est. primary completion date: June 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Months to 5 Years

Eligibility

Inclusion Criteria:

• Children from 6mos to 5 years of age requiring general anesthesia and a caudal block for a surgical procedure

Exclusion Criteria:

• Patients with preexisting conditions that could affect the skin temperature on the lower extremities such as infection, edema, vascular disorder, etc.

• American Society of Anesthesiologists comorbidity ranking of 4 or greater

• Patient with contraindications for a caudal block such as: history of allergic, reactions to local anesthetics, coagulopathy, infection at the injection site, spinal abnormality, peripheral neurological disease, Raynaud's disease

Related Conditions & MeSH terms

• Anesthesia, Conduction

Intervention

Device:
• FLIR ONE
Thermographic assessment of the lower extremities is obtained using the FLIR ONE smartphone camera and software.

Procedure:
• Regional Anesthesia - Caudal Nerve Block
Nerve block placement as a pain management strategy indicated for certain urological and lower extremity surgeries.

Locations

Country	Name	City	State
United States	Ann & Robert H. Lurie Children's Hospital	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Ann & Robert H Lurie Children's Hospital of Chicago

Country where clinical trial is conducted

United States, 

References & Publications (1)

Suresh S, Long J, Birmingham PK, De Oliveira GS Jr. Are caudal blocks for pain control safe in children? an analysis of 18,650 caudal blocks from the Pediatric Regional Anesthesia Network (PRAN) database. Anesth Analg. 2015 Jan;120(1):151-6. doi: 10.1213/ANE.0000000000000446. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Predictive value of FLIR ONE	Reviewers blinded to intervention groups will asses patient pre-caudal, 1, 2, 3, 4, and 5 minute post-caudal images and rate whether, based on the image, they believe the patient received a caudal or not. The sensitivity and specificity of the FLIR ONE as a diagnositic tol will then be determined.	Assessments will be done through study completion, an average of 1 week following procedure.
Secondary	Inter- and Intra- rater reliability	Reviewers will evaluate patient image at two separate ties at least a week apart. Recorded images will be compared within and between reviewers.	Assessments will be done through study completion, an average of 1 week following procedure.
Secondary	Temperature differences between pre-caudal and 5 minute post-caudal images	Temperature differences between pre-caudal and 5 minute images will be summarized in both groups. Images in the non-caudal group will be taken at similar time points following anesthesia induction relative to caudal group patients.	Images will be captured prior to caudal and 5 minutes immediately afterwards. Assessments will be done through study completion, an average of 1 week following procedure.