Accuro and the Use of Real Time Ultra Sound With Acoustic Puncture Assisted Device to Confirm Epidural Space End Point
NCT ID: NCT04204070
Last Updated: 2020-04-14
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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UNKNOWN
NA
100 participants
INTERVENTIONAL
2019-08-11
2020-06-11
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
SINGLE
Study Groups
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Group I Accuro
epidural catheter insertion using the Accuro ultrasound imaging assisted technique
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
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.
APAD
APAD
Interventions
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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
APAD
APAD
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* High risk pregnancy or precious baby.
* Patients not willing for participation.
20 Years
45 Years
FEMALE
Yes
Sponsors
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Alexandria University
OTHER
Responsible Party
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Yasser Mohamed Mohamed Osman
assistant professor of anesthesia Alexandria university
Locations
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Alexandria university
Alexandria, , Egypt
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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134/200
Identifier Type: -
Identifier Source: org_study_id
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