"Compuflo®" in Epidural Space Identification

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ClinicalTrials.gov Identifier: NCT03503656

Recruitment Status : Completed

First Posted : April 20, 2018

Last Update Posted : April 20, 2018

Sponsor:

Information provided by (Responsible Party):

Alessandro Di Filippo, Azienda Ospedaliero-Universitaria Careggi

Study Description

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.

Condition or disease	Intervention/treatment
Anesthesia, Epidural Analgesia, Epidural	Device: epidural catheter placement

Study Design

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Study Type :	Observational
Actual Enrollment :	140 participants
Observational Model:	Case-Only
Time Perspective:	Retrospective
Official Title:	Evaluation and Usability of "Compuflo®" in Epidural Anesthesia for Obstetric and Gynecological Areas
Actual Study Start Date :	January 2017
Actual Primary Completion Date :	April 2018
Actual Study Completion Date :	April 2018

Groups and Cohorts

Group/Cohort	Intervention/treatment
CompuFlo All the consecutive patients undergoing to an epidural catheter placement in Gynecological and Obstetric setting	Device: epidural catheter placement insertion of an epidural catheter using Compuflo System

Outcome Measures

Primary Outcome Measures :

was the number of successes [ Time Frame: 18 months ]
number

Secondary Outcome Measures :

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

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Older Adult)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

All the consecutive patients in gynecological and obstetric setting of a tertiary referral University Hospital submitted to epidural catheter insertion with CompuFlo® System

Criteria

Inclusion Criteria:

signed informed consent to procedure more than 18 years of age

Exclusion Criteria:

Contacts and Locations

No Contacts or Locations Provided

More Information

Publications:

Choi PT, Galinski SE, Takeuchi L, Lucas S, Tamayo C, Jadad AR. PDPH is a common complication of neuraxial blockade in parturients: a meta-analysis of obstetrical studies. Can J Anaesth. 2003 May;50(5):460-9.

Lechner TJ, van Wijk MG, Maas AJ, van Dorsten FR, Drost RA, Langenberg CJ, Teunissen LJ, Cornelissen PH, van Niekerk J. Clinical results with the acoustic puncture assist device, a new acoustic device to identify the epidural space. Anesth Analg. 2003 Apr;96(4):1183-1187. doi: 10.1213/01.ANE.0000052382.04446.42.

Ghelber O, Gebhard RE, Vora S, Hagberg CA, Szmuk P. Identification of the epidural space using pressure measurement with the compuflo injection pump--a pilot study. Reg Anesth Pain Med. 2008 Jul-Aug;33(4):346-52. doi: 10.1016/j.rapm.2008.01.012.

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Responsible Party:	Alessandro Di Filippo, Dr, Azienda Ospedaliero-Universitaria Careggi
ClinicalTrials.gov Identifier:	NCT03503656
Other Study ID Numbers:	CompuFlo AOUCareggi
First Posted:	April 20, 2018 Key Record Dates
Last Update Posted:	April 20, 2018
Last Verified:	April 2018

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	Yes
Product Manufactured in and Exported from the U.S.:	Yes

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