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

NCT04204070 | Unknown

• 1 other identifier: 134/200
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Two Different Techniques to Perform Epidural Using Ultrasound

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (1)

• compare the incidence of complications associated with each technique.

  the procedure time

Study Arms (2)

Group I Accuro

EXPERIMENTAL

epidural catheter insertion using the Accuro ultrasound imaging assisted technique

Procedure: Accuro

Group II APAD

EXPERIMENTAL

epidural catheter insertion using the real time ultrasound guided technique combined with the use of the acoustic puncture assist device (APAD) technique.

Procedure: APAD

Interventions

Accuro PROCEDURE

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

Group I Accuro

APAD PROCEDURE

APAD

Group II APAD

Eligibility Criteria

• Age: 20 Years - 45 Years
• Gender Eligibility Details: pregnant women
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Any contraindication for epidural analgesia
• High risk pregnancy or precious baby.
• Patients not willing for participation.

Sponsors & Collaborators

• Alexandria University: lead

Study Sites (1)

Alexandria university

Alexandria, Egypt

RECRUITING

MeSH Terms

Interventions

3-acetylpyridine adenine dinucleotide

Central Study Contacts

Yasser Mohamed Osman, assistant professor

CONTACT

01006357996; yasseralx@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant professor of anesthesia Alexandria university

Study Record Dates

• First Submitted: December 17, 2019
• First Posted: December 18, 2019
• Study Start: August 11, 2019
• Primary Completion: June 11, 2020
• Study Completion: June 11, 2020
• Last Updated: April 14, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP

Locations

EG (1)