Infrared Thermography for Assessment of Caudal Block in Children
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|ClinicalTrials.gov Identifier: NCT02907957|
Recruitment Status : Recruiting
First Posted : September 20, 2016
Last Update Posted : January 25, 2018
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.
|Condition or disease||Intervention/treatment|
|Anesthesia, Conduction||Device: FLIR ONE Procedure: Regional Anesthesia - Caudal Nerve Block|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Clinical Evaluation Of Infrared Thermography To Assess Successful Caudal Block In Children|
|Study Start Date :||September 2016|
|Estimated Primary Completion Date :||June 2018|
|Estimated Study Completion Date :||June 2018|
Active Comparator: Caudal
Participants 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.Procedure: Regional Anesthesia - Caudal Nerve Block
Nerve block placement as a pain management strategy indicated for certain urological and lower extremity surgeries.
Sham Comparator: No Caudal
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.
- Predictive value of FLIR ONE [ Time Frame: Assessments will be done through study completion, an average of 1 week following procedure. ]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.
- Inter- and Intra- rater reliability [ Time Frame: Assessments will be done through study completion, an average of 1 week following procedure. ]Reviewers will evaluate patient image at two separate ties at least a week apart. Recorded images will be compared within and between reviewers.
- Temperature differences between pre-caudal and 5 minute post-caudal images [ 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. ]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.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02907957
|Contact: John Hajdukemail@example.com|
|United States, Illinois|
|Ann & Robert H. Lurie Children's Hospital||Recruiting|
|Chicago, Illinois, United States, 60613|
|Contact: John Hajduk 312-227-5295|
|Principal Investigator:||Luis Sequera-Ramos, MD||Ann & Robert H Lurie Children's Hospital of Chicago|