Internal Jugular Vein CannulationUS_angleNCT02941094
Insertion Angle and Needle Visualization During Ultrasound Guided Internal Jugular Vein Cannulation
A study testing needle PLT-805AT and Ultrasound in people with Internal Jugular Vein Cannulation, run by Mansoura University at 1 site in Egypt.
Trial summary
Ultrasound guidance has been established as an effective and safe method during insertion of internal jugular vein catheter.. Needle visualization during advancement toward the vein has a great impact on both safety and success of the procedure. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Internal Jugular Vein Cannulation
- What is being tested?
- needle PLT-805AT and Ultrasound
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2016to Jul 2017
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- all patients requiring central line insertion
Who cannot join
- refusal
- coagulopathy
- neck surgeries
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Mansoura university
Al Mansurah, Dkahleya
Alreafey Kandeel, MD, 00201008158591, refa3ey2@yahoo.com
About this study
Ultrasound guidance has been established as an effective and safe method during insertion of internal jugular vein catheter.. Needle visualization during advancement toward the vein has a great impact on both safety and success of the procedure. Clinicians have adopted variable techniques to increase needle visualization including changing needle- probe relation (in-plane vs. out-of-plane), or using specific ultrasound needles The angle between the inserting needle and the probe lying on patient skin affects both the distance to the vein and the length of the needle part travelling through the us beam
- Conditions
- Internal Jugular Vein Cannulation
- Being tested
- needle PLT-805AT, Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
needle PLT-805ATDevice
Also called PLT-805AT, 8 MHz, Toshiba Tokyo, Japan
comparing success rate and complications using different needle to US probe angles.
UltrasoundDevice
Xario, Toshiba Tokyo Japan
| Study group | Role | What they receive |
|---|---|---|
| angle 30 group | Active comparator | During central line insertion, After choosing the proper position, the skin was infiltrated with %1 lidocaine. The vein will be localized using linear ultrasound probe (PLT-805AT, 8 MHz, Toshiba Tokyo, Japan) attached to ultrasound machine (Xario, Toshiba Tokyo Japan). The needle will be advanced guided by the ultrasound probe with needle skin angle 30-40 degree. Receives: Device: needle PLT-805AT; Device: Ultrasound |
| angle 50 group | Active comparator | During central line insertion,After choosing the proper position, the skin was infiltrated with %1 lidocaine. The vein will be localized using linear ultrasound probe (PLT-805AT, 8 MHz, Toshiba Tokyo, Japan) attached to ultrasound machine (Xario, Toshiba Tokyo Japan). The needle will be advanced guided by the ultrasound probe with needle skin angle 50-60 degree Receives: Device: needle PLT-805AT; Device: Ultrasound |
| angle 70 group | Active comparator | During central line insertion,After choosing the proper position, the skin was infiltrated with %1 lidocaine. The vein will be localized using linear ultrasound probe (PLT-805AT, 8 MHz, Toshiba Tokyo, Japan) attached to ultrasound machine (Xario, Toshiba Tokyo Japan). The needle will be advanced guided by the ultrasound probe with needle skin angle 60-80 degree Receives: Device: needle PLT-805AT; Device: Ultrasound |
What is being measured
The primary outcome is the main question the study is designed to answer.
success rate
Measured: 24 hours starting from central line insertion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2016 (estimated)
- Study startOct 2016
- Primary completionJun 2017 (estimated)
- Study completionJul 2017 (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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 150 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
- NCT02941094
- Sponsor's protocol ID
- refa-US-angle
- Acronym
- US_angle
- Status last verified
- Nov 2016
- First submitted
- 19 Jul 2016
- Last updated
- 22 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Insertion Angle and Needle Visualization During Ultrasound Guided Internal Jugular Vein Cannulation
- ClinicalTrials.gov ID
- NCT02941094
- Acronym / sponsor ID
- US_angle / refa-US-angle
- Conditions
- Internal Jugular Vein Cannulation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Mansoura UniversityUniversity, hospital or other
- Study start
- Oct 2016
- Primary completion
- Jun 2017 (estimated)
- Study completion
- Jul 2017 (estimated)
- First posted
- 21 Oct 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.
Ultrasound guidance has been established as an effective and safe method during insertion of internal jugular vein catheter.. Needle visualization during advancement toward the vein has a great impact on both safety and success of the procedure. Clinicians have adopted variable techniques to increase needle visualization including changing needle- probe relation (in-plane vs. out-of-plane), or using specific ultrasound needles The angle between the inserting needle and the probe lying on patient skin affects both the distance to the vein and the length of the needle part travelling through the us beam
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| angle 30 group | Active comparator | Device: needle PLT-805AT, Device: UltrasoundDuring central line insertion, After choosing the proper position, the skin was infiltrated with %1 lidocaine. The vein will be localized using linear ultrasound probe (PLT-805AT, 8 MHz, Toshiba Tokyo, Japan) attached to ultrasound machine (Xario, Toshiba Tokyo Japan). The needle will be advanced guided by the ultrasound probe with needle skin angle 30-40 degree. |
| angle 50 group | Active comparator | Device: needle PLT-805AT, Device: UltrasoundDuring central line insertion,After choosing the proper position, the skin was infiltrated with %1 lidocaine. The vein will be localized using linear ultrasound probe (PLT-805AT, 8 MHz, Toshiba Tokyo, Japan) attached to ultrasound machine (Xario, Toshiba Tokyo Japan). The needle will be advanced guided by the ultrasound probe with needle skin angle 50-60 degree |
| angle 70 group | Active comparator | Device: needle PLT-805AT, Device: UltrasoundDuring central line insertion,After choosing the proper position, the skin was infiltrated with %1 lidocaine. The vein will be localized using linear ultrasound probe (PLT-805AT, 8 MHz, Toshiba Tokyo, Japan) attached to ultrasound machine (Xario, Toshiba Tokyo Japan). The needle will be advanced guided by the ultrasound probe with needle skin angle 60-80 degree |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- all patients requiring central line insertion
Key exclusion criteria (3 listed)
- refusal
- coagulopathy
- neck surgeries
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 |
|---|---|---|
| needle PLT-805ATAlso: PLT-805AT, 8 MHz, Toshiba Tokyo, Japancomparing success rate and complications using different needle to US probe angles. | Device | angle 30 group, angle 50 group, angle 70 group |
| UltrasoundXario, Toshiba Tokyo Japan | Device | angle 30 group, angle 50 group, angle 70 group |
Primary outcome
success rate
Time frame: 24 hours starting from central line insertion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Nov 2016.
- Individual participant dataSharing planned: Undecided
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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 needle PLT-805AT and Ultrasound in people with Internal Jugular Vein Cannulation, run by Mansoura 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 22 Nov 2016. 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?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
success rate (time frame: 24 hours starting from central line insertion). 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 22 Nov 2016.