"Compuflo®" in Epidural Space Identification

NCT03503656 | Completed DMC FDA Device

• 1 other identifier: CompuFlo AOUCareggi
• Study Type: observational
• Target: 140
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anesthesia, Epidural; Analgesia, Epidural

Outcome Measures

Primary Outcomes (1)

• was the number of successes

  number

  18 months

Secondary Outcomes (5)

• the number of accidental dural punctures

  18 months

• the number of attempts

  18 months

• procedure time duration

  18 months

• measurement of pressure in the interspinous ligament, in the yellow ligament and within the epidural space

  18 months

• measurement of volume of saline injected by Compuflo®

  18 months

Study Arms (1)

CompuFlo

All the consecutive patients undergoing to an epidural catheter placement in Gynecological and Obstetric setting

Device: epidural catheter placement

Interventions

epidural catheter placement DEVICE

insertion of an epidural catheter using Compuflo System

CompuFlo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• signed informed consent to procedure more than 18 years of age

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria Careggi: lead

Related 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. doi: 10.1007/BF03021057.

  PMID: 12734154 BACKGROUND

• 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.

  PMID: 12651681 BACKGROUND

• 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.

  PMID: 18675746 BACKGROUND

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: April 5, 2018
• First Posted: April 20, 2018
• Study Start: January 1, 2017
• Primary Completion: April 1, 2018
• Study Completion: April 1, 2018
• Last Updated: April 20, 2018

Record last verified: 2018-04