Accuro and the Use of Real Time Ultra Sound With Acoustic Puncture Assisted Device to Confirm Epidural Space End Point

Comparing Between Ultrasound Assisted Epidural Catheter Placement Using Accuro and the Use of Ultra Sound Real Time With Acoustic Puncture Assisted Device to Confirm Epidural Space End Point

Aim of the work:

To compare the use of the Accuro ultrasound and a real time ultrasound guided epidural combined with the acoustic puncture assisted device to perform the epidural anesthesia Secondary aim is to compare the incidence of complications associated with each technique.

Patient's selection:

This study will be performed on 100 pregnant patients scheduled for normal vaginal delivery under epidural analgesia.

The sample size was calculated by taking success rate of conventional LOR to be 98% in the patients; assuming 80% power, with 95% confidence interval (CI) of two techniques and 30% margin of error.

The study protocol will be reviewed and approved by the Ethics Committee of the Alexandria Main University Hospitals.

A written consent will be obtained from all the patients participating in this study.

Complete history will be taken from all the patients and will be subjected to thorough examination and routine laboratory investigations. Patients will be randomly divided into two equal groups using a computer-generated program.

Group I consists of 50 patients scheduled for epidural catheter insertion using the Accuro ultrasound imaging assisted technique.

Group II consists of 50 patients scheduled for epidural catheter insertion using the real time ultrasound guided technique combined with the use of the acoustic puncture assist device (APAD) technique.

Study Overview

• Status: Unknown
• Conditions: Two Different Techniques to Perform Epidural Using Ultrasound
• Intervention / Treatment: Procedure: Accuro; Procedure: APAD

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Yasser Mohamed Osman, assistant professor; Phone Number: 002 01006357996; Email: yasseralx@hotmail.com

Study Locations

• Egypt
  • Alexandria, Egypt
    • Recruiting
    • Alexandria University
    • Contact: yasser osman; Email: yasseralx@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 45 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• pregnant patients scheduled for normal vaginal delivery under epidural analgesia.

Exclusion Criteria:

• • Any contraindication for epidural analgesia

  • High risk pregnancy or precious baby.
  • Patients not willing for participation.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group I Accuro; epidural catheter insertion using the Accuro ultrasound imaging assisted technique	Procedure: Accuro; A research coordinator recorded the depth of the EDS from skin, the number of attempts to perform the epidural anesthesia, the repositioning of the epidural needle either in the same space or in different space, the time taken for space localisation (it is defined as time taken in seconds from skin puncture until the successful space localisation).the total time of the procedure ( time measured from the patient is fully draped and in the proper sitting position till the end of insertion of the epidural catheter ) Any complications such as paresthesia during catheter insertion, dural puncture, blood in catheter and root irritation will be recorded
Experimental: Group II APAD; epidural catheter insertion using the real time ultrasound guided technique combined with the use of the acoustic puncture assist device (APAD) technique.	Procedure: APAD; APAD

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the depth of the EDS from skin,	inmm	the procedure time
the number of attempts to perform the epidural anesthesia, the repositioning of the epidural needle either in the same space or in different space	the number of attempts to perform the epidural anesthesia, the repositioning of the epidural needle either in the same space or in different space	the procedure time
, the time taken for space localisation .	(it is defined as time taken in seconds from skin puncture until the successful space localisation)	the procedure time
the total time of the procedure	( time measured from the patient is fully draped and in the proper sitting position till the end of insertion of the epidural catheter )	the procedure time

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
compare the incidence of complications associated with each technique.	compare the incidence of complications associated with each technique.	the procedure time

Collaborators and Investigators

• Sponsor: Alexandria University

Study record dates

Study Major Dates

• Study Start (Actual): August 11, 2019
• Primary Completion (Anticipated): June 11, 2020
• Study Completion (Anticipated): June 11, 2020

Study Registration Dates

• First Submitted: December 17, 2019
• First Submitted That Met QC Criteria: December 17, 2019
• First Posted (Actual): December 18, 2019

Study Record Updates

• Last Update Posted (Actual): April 14, 2020
• Last Update Submitted That Met QC Criteria: April 12, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: 134/200

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No