"Compuflo®" in Epidural Space Identification

Analgesia, Epidural Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03503656
• Other study ID #: CompuFlo AOUCareggi
• Status: Completed
• First received: April 5, 2018
• Last updated: April 11, 2018
• Start date: January 2017
• Est. completion date: April 2018

Study information

• Verified date: April 2018
• Source: Azienda Ospedaliero-Universitaria Careggi
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 140
• Est. completion date: April 2018
• Est. primary completion date: April 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

signed informed consent to procedure more than 18 years of age

Exclusion Criteria:

Related Conditions & MeSH terms

• Analgesia, Epidural
• Anesthesia, Epidural

Intervention

Device:
• epidural catheter placement
insertion of an epidural catheter using Compuflo System

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Azienda Ospedaliero-Universitaria Careggi

References & Publications (3)

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. — View 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. — View 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):1183-7, table of contents. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	was the number of successes	number	18 months
Secondary	the number of accidental dural punctures	number	18 months
Secondary	the number of attempts	number	18 months
Secondary	procedure time duration	seconds	18 months
Secondary	measurement of pressure in the interspinous ligament, in the yellow ligament and within the epidural space	mmHg	18 months
Secondary	measurement of volume of saline injected by Compuflo®	ml	18 months