Internal Jugular Vein CannulationSono-easeNCT02973841
Sono-ease Device for Internal Jaguar Vein Cannulation
A study testing Sono-ease device in people with Internal Jugular Vein Cannulation, run by Mansoura University.
Trial summary
A novel device attached to ultrasound probe designed to increase success rate and safety of internal jugular vein cannulation. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Internal Jugular Vein Cannulation
- What is being tested?
- Sono-ease device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Feb 2017to Jul 2018
- 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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- all patients indicated for IJV catheterization
Who cannot join
- neck deformities-coagulopathy
About this study
A novel device attached to ultrasound probe designed to increase success rate and safety of internal jugular vein cannulation.
- Conditions
- Internal Jugular Vein Cannulation
- Being tested
- Sono-ease device
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sono-ease deviceDevice
insertion of US guided IJV using sono-ease device
| Study group | Role | What they receive |
|---|---|---|
| Sono-ease group | Experimental | insertion IJV catheter using sono-ease device Receives: Device: Sono-ease device |
What is being measured
The primary outcome is the main question the study is designed to answer.
complications rate
hematoma-arterial puncture-pneumothorax
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2016 (estimated)
- Study startFeb 2017
- Primary completionJul 2018 (estimated)
- Study completionJul 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Internal Jugular Vein CannulationStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mansoura University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, AlRefaey Kandeel, Mansoura University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02973841
- Sponsor's protocol ID
- Sono-ease
- Acronym
- Sono-ease
- Status last verified
- Nov 2016
- First submitted
- 22 Nov 2016
- Last updated
- 25 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sono-ease Device for Internal Jaguar Vein Cannulation
- ClinicalTrials.gov ID
- NCT02973841
- Acronym / sponsor ID
- Sono-ease / Sono-ease
- Conditions
- Internal Jugular Vein Cannulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Feb 2017
- Primary completion
- Jul 2018 (estimated)
- Study completion
- Jul 2018 (estimated)
- First posted
- 25 Nov 2016 (estimated)
- 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.
A novel device attached to ultrasound probe designed to increase success rate and safety of internal jugular vein cannulation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Sono-ease group | Experimental | Device: Sono-ease deviceinsertion IJV catheter using sono-ease device |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- all patients indicated for IJV catheterization
Key exclusion criteria (1 listed)
- neck deformities-coagulopathy
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 |
|---|---|---|
| Sono-ease deviceinsertion of US guided IJV using sono-ease device | Device | Sono-ease group |
Primary outcome
complications rate
Time frame: 24 hours
hematoma-arterial puncture-pneumothorax
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Nov 2016.
- Individual participant dataSharing planned: Yes
Related trials for Internal Jugular Vein Cannulation
Not yet recruitingObservational study
Ultrasound Assessment of Internal Jugular Vein for Cannulation and Venous Pressure Prediction
Vascular Access, Elevated Jugular Venous Pressure
Not yet recruiting
Comparison of Short-Axis and Long-Axis Internal Jugular Vein Cannulation for First-Pass Success
Cannulation of Internal Jugular Vein
Not yet recruiting
Ultrasound-Guided BCV and IJV in ICU Patients
Ultrasound-Guided Vascular Access, ICU Patients
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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Sono-ease device in people with Internal Jugular Vein Cannulation, run by Mansoura University.
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 1 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 25 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
complications rate (time frame: 24 hours). 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 25 Nov 2016.