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Infrared Thermography for Assessment of Caudal Block in Children

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ClinicalTrials.gov Identifier: NCT02907957
Recruitment Status : Completed
First Posted : September 20, 2016
Last Update Posted : July 17, 2018
Sponsor:
Information provided by (Responsible Party):
Luis Sequera-Ramos, Ann & Robert H Lurie Children's Hospital of Chicago

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
Anesthesia, Conduction Device: FLIR ONE Procedure: Regional Anesthesia - Caudal Nerve Block Not Applicable

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Screening
Official Title: A Clinical Evaluation Of Infrared Thermography To Assess Successful Caudal Block In Children
Actual Study Start Date : September 2016
Actual Primary Completion Date : June 2018
Actual Study Completion Date : June 28, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anesthesia

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.




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   6 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02907957


Locations
United States, Illinois
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

Publications:
Responsible Party: Luis Sequera-Ramos, Resident Physician, Anesthesiology, Ann & Robert H Lurie Children's Hospital of Chicago
ClinicalTrials.gov Identifier: NCT02907957     History of Changes
Other Study ID Numbers: IRB 2016-590
First Posted: September 20, 2016    Key Record Dates
Last Update Posted: July 17, 2018
Last Verified: July 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No