Thermographic Imaging in Epidural Anesthesia

June 14, 2023 updated by: Pamela Gonzalez Sr Director Clinical Research Office, Cook County Health

Infrared Thermographic Imaging for Early Assessment of Epidural Block Success in Obstetric Anesthesia

The purpose of this study is to describe infrared thermographic imaging as a tool for the assessment of epidural block in obstetrics patients

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

Patients will recive standard anesthesia care for epidural placement and additionally, thermographic imaging will be obtained at baseline and up to 30 min after the epidural blockade is performed.

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Parturients in active labor, older than18 year of age, requesting epidural anesthesia for normal vaginal delivery

Description

Inclusion Criteria:

  • Parturients in active labor requesting epidural anesthesia for normal vaginal delivery

Exclusion Criteria:

  • Patients with lower extremity skin disorders like active infections like cellulitis, ,dermatitis, psoriasis or connective tissue disorders like scleroderma or Raynaud's phenomenon
  • Patients with diagnosed peripheral vascular disease ,venous stasis , deep venous thrombosis.
  • Patients with Severe preeclampsia with significant lower extremity edema
  • Patient on vasoactive agents like vasodilators, calcium channels blockers.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
A
Pt receiving standard Epidural block care for vaginal delivery
Device: Thermographic imaging
Using infrared-recording camera will obtain thermographic images of the lower extremities before and after the epidural blockade

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in temperature in the lower extremities
Time Frame: at baseline, 5 min before the epidural blockade, during and up to 30 minutes after performing the epidural blockade
thermographic images of the lower extremities will be obtained and analyzed for thermography patterns.
at baseline, 5 min before the epidural blockade, during and up to 30 minutes after performing the epidural blockade

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Successful epidural blockade
Time Frame: up to 30 min after performing the epidural block
adequate sensory level, pain control, motor blockade as evaluated by care provider
up to 30 min after performing the epidural block
Epidural blockade failure
Time Frame: Up to 30 min after performing the epidural block
Failure of the epidural block to adequately control pain, unilateral blockade, optimal sensory level, inadequate motor blockade
Up to 30 min after performing the epidural block
Requirement for Epidural catheter manipulation or replacement
Time Frame: Up to 30 min after performing the epidural block
Up to 30 min after performing the epidural block

Other Outcome Measures

Outcome Measure
Time Frame
Peri-procedural Complications
Time Frame: participants will be followed for the duration of anesthesia and after the procedure, an expected average of 12 hours
participants will be followed for the duration of anesthesia and after the procedure, an expected average of 12 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cook County Health

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 2, 2016

Primary Completion (Actual)

November 17, 2017

Study Completion (Actual)

November 17, 2017

Study Registration Dates

First Submitted

March 29, 2016

First Submitted That Met QC Criteria

April 11, 2016

First Posted (Estimated)

April 15, 2016

Study Record Updates

Last Update Posted (Actual)

June 15, 2023

Last Update Submitted That Met QC Criteria

June 14, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • IRB# 16-012

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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