ClinicalTrials.gov
ClinicalTrials.gov Menu

Compuflo Instrument for Thoracic ES Identification

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.
ClinicalTrials.gov Identifier: NCT03376256
Recruitment Status : Recruiting
First Posted : December 18, 2017
Last Update Posted : May 17, 2018
Sponsor:
Information provided by (Responsible Party):
Ralf E. Gebhard, MD, University of Miami

Brief Summary:
The purpose of this pilot study is to evaluate whether the Compuflo Epidural Instrument injection pump technology, which is FDA approved for lumbar epidural anesthesia, is also capable of identifying the thoracic epidural space through measurement of pressure levels. While this device is approved by the FDA for use in the procedure of the lumbar epidural, it is not used to perform the epidural procedure but rather to measure the epidural pressure. This study will likewise measure the epidural pressure.

Condition or disease Intervention/treatment Phase
Anesthesia Thoracic Device: Compuflo Epidural Instrument Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: Evaluation of the Compuflo Epidural Instrument for Thoracic Epidural Space Identification
Estimated Study Start Date : December 1, 2018
Estimated Primary Completion Date : June 1, 2019
Estimated Study Completion Date : December 1, 2019

Arm Intervention/treatment
Experimental: Phase A - Thoracic ES with LOR
Patients will receive thoracic epidural anesthesia. The thoracic epidural needle will be introduced until loss of resistance (LOR) is perceived to identify the thoracic epidural space (ES). The Compuflo Epidural Instrument will be used to record pressure readings. The thoracic epidural procedure will then continue per standard of care.
Device: Compuflo Epidural Instrument
Compuflo Epidural Instrument will be used to measure pressure levels in the thoracic epidural space while performing thoracic epidural anesthesia.

Experimental: Phase B - Thoracic ES with Compuflo
Patients will receive thoracic epidural anesthesia. The thoracic epidural needle will be introduced until the Compuflo Epidural Instrument indicates that pressure has decreased. The loss of resistance technique will then be used to identify the thoracic epidural space. The thoracic epidural procedure will then continue per standard of care.
Device: Compuflo Epidural Instrument
Compuflo Epidural Instrument will be used to measure pressure levels in the thoracic epidural space while performing thoracic epidural anesthesia.




Primary Outcome Measures :
  1. Pressure levels in thoracic epidural space [ Time Frame: Day 1 ]
    The Compuflo Epidural Instrument measures the pressure levels in millimeters of mercury (mmHg) in the thoracic epidural space


Secondary Outcome Measures :
  1. Percent of successful performance of thoracic epidural anesthesia using loss of resistance technique [ Time Frame: Day 1 ]
    Percent of thoracic epidural anesthesia procedures using LOR that result in a loss of sensation to cold in at least one dermatome, either unilateral or bilateral



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age 18 to 80 years inclusive
  • BMI 18.5 to 40 inclusive
  • Scheduled for thoracic epidural anesthesia

Exclusion Criteria:

  • Patients younger than 18 years or older than 80 years of age
  • Patients with BMI less than 18.5 or greater than 40
  • Contraindication to thoracic epidural anesthesia
  • Allergy or hypersensitivity to local anesthetics
  • Patients with preexisting nerve damage
  • Patients unable to provide written informed consent
  • Individuals of vulnerable populations: children, pregnant women, prisoners

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): NCT03376256


Contacts
Contact: Ralf E Gebhard, MD 305-585-8365 rgebhard@med.miami.edu
Contact: Robyn Weisman, MD 305-585-8365 rweisman@med.miami.edu

Locations
United States, Florida
University of Miami Hospital Recruiting
Miami, Florida, United States, 33136
Contact: Ralf E Gebhard, MD    305-585-8365    rgebhard@med.miami.edu   
Sponsors and Collaborators
University of Miami
Investigators
Principal Investigator: Ralf E Gebhard, MD University of Miami

Publications:
Responsible Party: Ralf E. Gebhard, MD, Professor of Clinical Anesthesiology, University of Miami
ClinicalTrials.gov Identifier: NCT03376256     History of Changes
Other Study ID Numbers: 20170665
First Posted: December 18, 2017    Key Record Dates
Last Update Posted: May 17, 2018
Last Verified: February 2018

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Ralf E. Gebhard, MD, University of Miami:
thoracic epidural
pressure measurement
device