Infrared Thermography for Assessment of Caudal Block in Children
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| 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.
|
Outcome Measures
Primary Outcome Measures
- Predictive value of FLIR ONE [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.
Secondary Outcome Measures
- Inter- and Intra- rater reliability [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 [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.
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ann & Robert H. Lurie Children's Hospital | Chicago | Illinois | United States | 60613 |
Sponsors and Collaborators
- Ann & Robert H Lurie Children's Hospital of Chicago
Investigators
- Principal Investigator: Luis Sequera-Ramos, MD, Ann & Robert H Lurie Children's Hospital of Chicago
Study Documents (Full-Text)
None provided.More Information
Publications
- IRB 2016-590