Compuflo® in Epidural Space Identification

Study Overview
=================
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.

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

Conditions
-----------------
Anesthesia, Epidural, Analgesia, Epidural

Intervention / Treatment
-----------------
* Device: epidural catheter placement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: signed informed consent to procedure more than 18 years of age Exclusion Criteria: NO

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| CompuFlo<br>All the consecutive patients undergoing to an epidural catheter placement in Gynecological and Obstetric setting | Device: epidural catheter placement<br>* insertion of an epidural catheter using Compuflo System<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| was the number of successes | number | 18 months | 

Secondary Outcome Measures

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