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Compuflo® in Epidural Space Identification

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03503656
Enrollment
140
Registered
2018-04-20
Start date
2017-01-31
Completion date
2018-04-30
Last updated
2018-04-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Analgesia, Epidural, Anesthesia, Epidural

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.

Interventions

insertion of an epidural catheter using Compuflo System

Sponsors

Azienda Ospedaliero-Universitaria Careggi
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

signed informed consent to procedure more than 18 years of age

Exclusion criteria

NO

Design outcomes

Primary

MeasureTime frameDescription
was the number of successes18 monthsnumber

Secondary

MeasureTime frameDescription
the number of accidental dural punctures18 monthsnumber
the number of attempts18 monthsnumber
procedure time duration18 monthsseconds
measurement of pressure in the interspinous ligament, in the yellow ligament and within the epidural space18 monthsmmHg
measurement of volume of saline injected by Compuflo®18 monthsml

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026