Compuflo Instrument for Thoracic ES Identification

Study Overview
=================
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.

Official Title
-----------------
Evaluation of the Compuflo Epidural Instrument for Thoracic Epidural Space Identification

Conditions
-----------------
Anesthesia, Thoracic

Intervention / Treatment
-----------------
* Device: Compuflo Epidural Instrument


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phase A - Thoracic ES with LOR<br>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<br>* Compuflo Epidural Instrument will be used to measure pressure levels in the thoracic epidural space while performing thoracic epidural anesthesia.<br>|
| Experimental: Phase B - Thoracic ES with Compuflo<br>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<br>* Compuflo Epidural Instrument will be used to measure pressure levels in the thoracic epidural space while performing thoracic epidural anesthesia.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pressure Levels in Thoracic Epidural Space | The Compuflo Epidural Instrument measures the pressure levels in millimeters of mercury (mmHg) in the thoracic epidural space | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Successful Performance of Thoracic Epidural Anesthesia Using Loss of Resistance Technique | 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 | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
thoracic epidural, pressure measurement, device