NCT03503656

"Compuflo®" in Epidural Space Identification

Evaluation and Usability of "Compuflo®" in Epidural Anesthesia for Obstetric and Gynecological Areas

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 140 (actual)
• Sponsor: Azienda Ospedaliero-Universitaria Careggi · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Recently a computerized injection pump has been programmed with its own mathematical algorithm to measure on a digital display the pressure trend in the form of a continuous curve and it has been connected to an acoustic device that emits a sound at increasing frequencies during the progress of the epidural needle (Compuflo®, Milestone Scientific, Livingston, NJ); it has therefore been made capable of controlling the pressure at the injection point and adjusting the infusion rate according to a predetermined maximum value using the registered Dynamic Pressure Sensing (DPS) technology. The Compuflo® system guarantees feedback on simultaneous and continuous pressure data, both visual and auditory, identifying and differentiating the different types of tissue. This safe and effective feedback helps medical personnel to identify the epidural space with greater accuracy and alerts them if the needle moves into the identified position. The aim of the study was to verify the efficacy and usability of the Compuflo® system in a clinical setting. The setting was the area of gynecology and obstetrics at a tertiary referral level University Hospital. All the consecutive patients undergoing to an epidural catheter placement with Compuflo® were collected until to a sample size of 140 patients. Primary endpoint was the number and percentage of successes in the placement of epidural catheters with Compuflo® Epidural. Secondary endpoints were: the number and percentage of accidental dural punctures during epidural catheter placement; the number of attempts aimed at the correct positioning of the epidural catheter; the measurement of procedure time duration; the measurement of pressure in the interspinous ligament, in the yellow ligament and within the epidural space; the measurement of volume of saline injected by Compuflo® to identify the epidural space.

Conditions

• Anesthesia, Epidural
• Analgesia, Epidural

Interventions

Type	Name	Description
DEVICE	epidural catheter placement	insertion of an epidural catheter using Compuflo System

Timeline

• Start date: 2017-01-01
• Primary completion: 2018-04-01
• Completion: 2018-04-01
• First posted: 2018-04-20
• Last updated: 2018-04-20

Regulatory

• FDA-regulated device study