Two Different Techniques to Perform Epidural Using UltrasoundNCT04204070
Accuro and the Use of Real Time Ultra Sound With Acoustic Puncture Assisted Device to Confirm Epidural Space End Point
A study testing Accuro and APAD in people with Two Different Techniques to Perform Epidural Using Ultrasound, run by Alexandria University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Two Different Techniques to Perform Epidural Using Ultrasound
- What is being tested?
- Accuro and APAD
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 11 Aug 2019to 11 Jun 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- pregnant patients scheduled for normal vaginal delivery under epidural analgesia.
Who cannot join
- • Any contraindication for epidural analgesia
- High risk pregnancy or precious baby.
- Patients not willing for participation.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Alexandria university
Alexandria
yasser osman, yasseralx@hotmail.com
About this study
Official title: 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.
Read more
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.
- Being tested
- Accuro, APAD
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AccuroProcedure or surgery
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
APADProcedure or surgery
APAD
| Study group | Role | What they receive |
|---|---|---|
| Group I Accuro | Experimental | epidural catheter insertion using the Accuro ultrasound imaging assisted technique Receives: 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. Receives: Procedure: APAD |
What is being measured
The primary outcome is the main question the study is designed to answer.
the depth of the EDS from skin,
inmm
Measured: 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
Measured: 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)
Measured: 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 )
Measured: the procedure time
Secondary outcomes (1)
compare the incidence of complications associated with each technique.
compare the incidence of complications associated with each technique.
Measured: the procedure time
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2019
- Study start11 Aug 2019
- Primary completion11 Jun 2020 (estimated)
- Study completion11 Jun 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Two Different Techniques to Perform Epidural Using UltrasoundStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasser Mohamed Mohamed Osman, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04204070
- Sponsor's protocol ID
- 134/200
- Status last verified
- Apr 2020
- First submitted
- 17 Dec 2019
- Last updated
- 14 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT04204070
- Acronym / sponsor ID
- 134/200
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 11 Aug 2019 (actual)
- Primary completion
- 11 Jun 2020 (estimated)
- Study completion
- 11 Jun 2020 (estimated)
- First posted
- 18 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I Accuro | Experimental | Procedure: Accuroepidural catheter insertion using the Accuro ultrasound imaging assisted technique |
| Group II APAD | Experimental | Procedure: APADepidural catheter insertion using the real time ultrasound guided technique combined with the use of the acoustic puncture assist device (APAD) technique. |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- pregnant patients scheduled for normal vaginal delivery under epidural analgesia.
Key exclusion criteria (3 listed)
- • Any contraindication for epidural analgesia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AccuroA 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 | Procedure or surgery | Group I Accuro |
| APADAPAD | Procedure or surgery | Group II APAD |
Primary outcome
the depth of the EDS from skin,
Time frame: the procedure time
inmm
the number of attempts to perform the epidural anesthesia, the repositioning of the epidural needle either in the same space or in different space
Time frame: 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 time taken for space localisation .
Time frame: the procedure time
(it is defined as time taken in seconds from skin puncture until the successful space localisation)
the total time of the procedure
Time frame: the procedure time
( time measured from the patient is fully draped and in the proper sitting position till the end of insertion of the epidural catheter )
1 secondary outcome
compare the incidence of complications associated with each technique.
Time frame: the procedure time
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2020.
- Individual participant dataSharing planned: Yes
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Accuro and APAD in people with Two Different Techniques to Perform Epidural Using Ultrasound, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 14 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Yasser Mohamed Osman, assistant professor (01006357996 ext. 002, yasseralx@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the depth of the EDS from skin, (time frame: the procedure time). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Apr 2020.