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OpenTrials
Completed

NCT Number: NCT03503656

"Compuflo®" in Epidural Space Identification

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.

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Key information

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

signed informed consent to procedure more than 18 years of age

Exclusion criteria

NO

Treatment and study plan

epidural catheter placement

Device

insertion of an epidural catheter using Compuflo System

Primary outcomes

  1. was the number of successes

    Time frame: 18 months

    number

Secondary outcomes

  1. the number of accidental dural punctures

    Time frame: 18 months

    number

  2. the number of attempts

    Time frame: 18 months

    number

  3. procedure time duration

    Time frame: 18 months

    seconds

  4. measurement of pressure in the interspinous ligament, in the yellow ligament and within the epidural space

    Time frame: 18 months

    mmHg

  5. measurement of volume of saline injected by Compuflo®

    Time frame: 18 months

    ml

Sponsors and collaborators

Lead sponsor

Azienda Ospedaliero-Universitaria Careggi

Other

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 20, 2018
Registry last updated
Apr 20, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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