Compuflo Instrument for Thoracic ES Identification



Status:Recruiting
Conditions:Hospital
Therapuetic Areas:Other
Healthy:No
Age Range:18 - 80
Updated:2/8/2019
Start Date:July 11, 2018
End Date:June 1, 2021
Contact:Ralf E Gebhard, MD
Email:rgebhard@med.miami.edu
Phone:305-585-8365

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Trial Summary
Trial Overview
Inclusion Criteria

Evaluation of the Compuflo Epidural Instrument for Thoracic Epidural Space Identification

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.


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
We found this trial at
1
site
University of Miami Hospital
1400 NW 12th Ave
Miami, Florida 33136
(305) 689-5511
Phone: 305-585-8365
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