Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
140 participants
OBSERVATIONAL
2017-01-31
2018-04-30
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
RETROSPECTIVE
Study Groups
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CompuFlo
All the consecutive patients undergoing to an epidural catheter placement in Gynecological and Obstetric setting
epidural catheter placement
insertion of an epidural catheter using Compuflo System
Interventions
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epidural catheter placement
insertion of an epidural catheter using Compuflo System
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
18 Years
FEMALE
No
Sponsors
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Azienda Ospedaliero-Universitaria Careggi
OTHER
Responsible Party
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Alessandro Di Filippo
Dr
References
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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.
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.
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.
Other Identifiers
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CompuFlo AOUCareggi
Identifier Type: -
Identifier Source: org_study_id
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