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Infrared Thermography for Assessment of Caudal Block in Children

This study is currently recruiting participants.
Verified September 2016 by Luis Sequera-Ramos, Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor:
ClinicalTrials.gov Identifier:
NCT02907957
First Posted: September 20, 2016
Last Update Posted: September 20, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Luis Sequera-Ramos, Ann & Robert H Lurie Children's Hospital of Chicago
  Purpose

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 Intervention
Anesthesia, Conduction Device: FLIR ONE Procedure: Regional Anesthesia - Caudal Nerve Block

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Luis Sequera-Ramos, Ann & Robert H Lurie Children's Hospital of Chicago:

Primary Outcome Measures:
  • 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:
  • 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.


Estimated Enrollment: 100
Study Start Date: September 2016
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Information from the National Library of Medicine

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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
  Contacts and Locations
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


Contacts
Contact: John Hajduk 312-227-5295 jhajduk@luriechildrens.org

Locations
United States, Illinois
Ann & Robert H. Lurie Children's Hospital Recruiting
Chicago, Illinois, United States, 60613
Contact: John Hajduk    312-227-5295      
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
  More Information

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 Submitted: September 9, 2016
First Posted: September 20, 2016
Last Update Posted: September 20, 2016
Last Verified: September 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No