Clinical trial NCT03376256: Compuflo Instrument for Thoracic ES Identification
Official title: Evaluation of the Compuflo Epidural Instrument for Thoracic Epidural Space Identification
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Anesthesia
Thoracic
Keywords: thoracic epidural
pressure measurement
device
Lead sponsor: University of Miami
Sponsor class: OTHER
First posted: 2017-12-18
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Pressure Levels in Thoracic Epidural Space
timeFrame: Day 1
Secondary outcomes:
measure: Percent of Successful Performance of Thoracic Epidural Anesthesia Using Loss of Resistance Technique
timeFrame: Day 1
Other outcomes:
Locations:
city: Miami
country: United States
facility: University of Miami Hospital
state: Florida
Study officials:
affiliation: University of Miami
name: Ralf E Gebhard, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Thangamuthu A, Russell IF, Purva M. Epidural failure rate using a standardised definition. Int J Obstet Anesth. 2013 Nov;22(4):310-5. doi: 10.1016/j.ijoa.2013.04.013. Epub 2013 Aug 6.
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