"Compuflo®" in Epidural Space Identification

Completed

• Conditions: Anesthesia, Epidural; Analgesia, Epidural
• Interventions: Device: epidural catheter placement

• Registration Number: NCT03503656
• Lead Sponsor: Azienda Ospedaliero-Universitaria Careggi

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-01
• Status Verified: 2018-04
• Primary Completion: 2018-04
• Study Completion: 2018-04
• Study First Submitted: 2018-04-05
• Study First Submitted QC: 2018-04-11
• Last Update Submitted: 2018-04-11
• Study First Posted: 2018-04-20
• Last Update Posted: 2018-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 140

Inclusion Criteria

signed informed consent to procedure more than 18 years of age

Exclusion Criteria

NO

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
CompuFlo	epidural catheter placement	All the consecutive patients undergoing to an epidural catheter placement in Gynecological and Obstetric setting

Primary Outcome Measures

Name	Time	Method
was the number of successes	18 months	number

Secondary Outcome Measures

Name	Time	Method
the number of attempts	18 months	number
the number of accidental dural punctures	18 months	number
procedure time duration	18 months	seconds
measurement of volume of saline injected by Compuflo®	18 months	ml
measurement of pressure in the interspinous ligament, in the yellow ligament and within the epidural space	18 months	mmHg