Compuflo Instrument for Thoracic ES Identification

University of Miami

Status: Terminated

Conditions: Thoracic; Anesthesia

Treatments: Device: Compuflo Epidural Instrument

Study type: Interventional

Funder types: Other

Identifiers

NCT03376256

20170665

Details and patient eligibility

About

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.

Enrollment: 2 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2 participants in 2 patient groups

Phase A - Thoracic ES with LOR

Experimental group

Description:

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.

Treatment:

Device: Compuflo Epidural Instrument

Phase B - Thoracic ES with Compuflo

Experimental group

Description:

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.

Treatment:

Device: Compuflo Epidural Instrument