Epidural Computer Controlled System for the Epidural Space Verification

NCT03165708 | Completed

• 1 other identifier: 001
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

Brief Summary

The purpose of this study will be to evaluate the inter-rater agreement, or concordance, between an expert anaesthesiologist and the CompuFlo® Epidural Computer Controlled System for the epidural space verification. Primary study endpoint will be successful concordance of identification of ligamentum flavum and epidural space during a standard epidural procedure in pregnant patient. Secondary outcome will be successful concordance of identification of bony contact during a standard epidural procedure in pregnant patient.

Conditions

Epidural

Keywords

Epidural technique

Outcome Measures

Primary Outcomes (1)

• concordance between anesthesiologist and Compuflo

  Primary study endpoint will be successful concordance of identification of ligamentum flavum and epidural space during a standard epidural procedure in pregnant patient.

  during epidural technique performance

Study Arms (1)

anesthesiologist

The active comparators for this study will be expert anaesthesiologists (operator). The operators will be blinded to all visual and audible CompuFlo® real-time pressure feedbacks.Inter-rater agreement, or concordance, between an expert anaesthesiologist and the CompuFlo® Epidural Computer Controlled System for the epidural space verification will be assessed by blinded tagging of the operator's feeling of the ligamenta and epidural space on the screen of the Compuflo to be eventually compared with the pressure's variations

Eligibility Criteria

• Age: 18 Years - 45 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Healthy parturients

You may qualify if:

• Parturients undergoing epidural block for cesarean section or labor analgesia

Sponsors & Collaborators

• Città di Roma Hospital: lead

Related Publications (1)

• 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 RESULT

Study Officials

• Giorgio Capogna

  Citta di Roma Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head Department Anesthesia

Study Record Dates

• First Submitted: May 22, 2017
• First Posted: May 24, 2017
• Study Start: January 2, 2017
• Primary Completion: May 16, 2017
• Study Completion: May 20, 2017
• Last Updated: May 24, 2017

Record last verified: 2017-05

Data Sharing

• IPD Sharing: Will not share