Clinical trial NCT03503656: "Compuflo®" in Epidural Space Identification
Official title: Evaluation and Usability of "Compuflo®" in Epidural Anesthesia for Obstetric and Gynecological Areas
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia, Epidural
Analgesia, Epidural
Lead sponsor: Azienda Ospedaliero-Universitaria Careggi
Sponsor class: OTHER
First posted: 2018-04-20
Enrollment: 140
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
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

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.


Eligibility criteria: Inclusion Criteria:

signed informed consent to procedure more than 18 years of age

Exclusion Criteria:

NO

Primary outcomes:
measure: was the number of successes
timeFrame: 18 months
Secondary outcomes:
measure: the number of accidental dural punctures
timeFrame: 18 months
measure: the number of attempts
timeFrame: 18 months
measure: procedure time duration
timeFrame: 18 months
measure: measurement of pressure in the interspinous ligament, in the yellow ligament and within the epidural space
timeFrame: 18 months
measure: measurement of volume of saline injected by Compuflo®
timeFrame: 18 months
Other outcomes:
Locations:
Study officials:
References:
citation: 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. doi: 10.1007/BF03021057.
citation: 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.
citation: 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.