Compuflo Instrument for Thoracic ES Identification

Not Applicable

Terminated

• Conditions: Thoracic; Anesthesia
• Interventions: Device: Compuflo Epidural Instrument

• Registration Number: NCT03376256
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-12-12
• Study First Submitted QC: 2017-12-12
• Study First Posted: 2017-12-18
• Study Start: 2018-07-11
• Primary Completion: 2018-07-17
• Study Completion: 2018-07-17
• Status Verified: 2020-11
• Results First Submitted: 2020-11-10
• Results First Submitted QC: 2020-11-10
• Last Update Submitted: 2020-11-10
• Results First Posted: 2020-12-03
• Last Update Posted: 2020-12-03

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Phase A - Thoracic ES with LOR	Compuflo Epidural Instrument	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.
Phase B - Thoracic ES with Compuflo	Compuflo Epidural Instrument	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.

Primary Outcome Measures

Name	Time	Method
Pressure Levels in Thoracic Epidural Space	Day 1	The Compuflo Epidural Instrument measures the pressure levels in millimeters of mercury (mmHg) in the thoracic epidural space

Secondary Outcome Measures

Name	Time	Method
Percent of Successful Performance of Thoracic Epidural Anesthesia Using Loss of Resistance Technique	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

Trial Locations

Locations (1)

University of Miami Hospital; 🇺🇸 Miami, Florida, United States