An interventional study of FLIR ONE and Regional Anesthesia - Caudal Nerve Block in Anesthesia, Conduction, sponsored by Ann & Robert H Lurie Children's Hospital of Chicago. Completed at 1 site in United States. Open to participants aged 6 Months to 5 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-08-20.
Sponsored by Ann & Robert H Lurie Children's Hospital of Chicago · Not applicable, Interventional, and Screening
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.
Ann & Robert H Lurie Children's Hospital of Chicago is the lead sponsor of 176 studies on the registry; 30 are open to participants now.
Of its 10 completed or terminated interventional studies of FDA-regulated products, 5 (50%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants receiving a caudal neuraxial blockade, as clinically indicated.
Device: FLIR ONE · Procedure: Regional Anesthesia - Caudal Nerve Block
Participants not receiving a caudal neuraxial blockade, as clinically indicated.
Device: FLIR ONE
Thermographic assessment of the lower extremities is obtained using the FLIR ONE smartphone camera and software.
Nerve block placement as a pain management strategy indicated for certain urological and lower extremity surgeries.
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.
Time frame: Assessments will be done through study completion, an average of 1 week following procedure.
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.
Time frame: Assessments will be done through study completion, an average of 1 week following procedure.
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.
Time frame: 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.
Plan to share: No
This study is completed, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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Ann & Robert H Lurie Children's Hospital of Chicago