AnesthesiaNCT04224259
Ultrasound Pre-scan to Reduce Needle Redirection During Right Jugular Vein Cannulation
A study testing Ultrasound pre-scan and Landmark guidance in people with Anesthesia, run by Taipei Medical University WanFang Hospital.
Trial summary
This study aims to define a simple, safe, and effective ultrasound pre-scan technique for right internal jugular vein (RIJV) cannulation. After placing the patient properly, the operator puts a linear ultrasound probe at the mid neck in short-axis view. Read more about this study
- Who is it for?
- Ages 20 to 79 years
- Conditions the study is for
- Anesthesia
- What is being tested?
- Ultrasound pre-scan and Landmark guidance
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- Feb 2020to Mar 2021
- 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 79 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Older than 20 years and younger than 80 years of age
- American Society of Anesthesiologists Physical Status Classification I-III (no immediate life-threatening condition)
- Scheduled for regular surgery
- Receive general anesthesia with endotracheal tube intubation
- In need of central venous catheter placement
Who cannot join
- Body Mass Index > 35kg/m^2
- Abnormal anatomy of the neck
- Limited range of motion of the neck
- The surgery does not allow right internal jugular vein cannulation or other contraindications for the procedure
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Utility of Vertical Puncture Technique Assisted by Ultrasound Pre-scan to Reduce Needle Redirection During Right Jugular Vein Cannulation
This study aims to define a simple, safe, and effective ultrasound pre-scan technique for right internal jugular vein (RIJV) cannulation. After placing the patient properly, the operator puts a linear ultrasound probe at the mid neck in short-axis view. With the IVJ in the center of the screen, the operator makes marks at both ends of the transducer (mark A and B), and then rotates the transducer 90 degrees counterclockwise. After finding IJV in long-axis view with transducer vertical to the ground, other two marks are made at both ends of the transducer (mark C and D). After proper preparation, the operator recognizes the cross point made by the imagined lines of marks AB and marks CD (point E). The needle is inserted vertically to the ground at point E.
Inclusion criteria are adult patients receiving general anesthesia in need of central venous cannulation.The primary endpoint is the number of needle redirection, and secondary endpoints include first attempt success rate, artery puncture, complication, number of wire attempt, number of skin insertion, venous access time, catheterization time, and malposition. The hypothesis is that this ultrasound pre-scan method would have a fewer number of needle redirection, a higher first-attempt success rate, as well as less complication, number of redirection.
Read the detailed description
Ultrasound-guided central venous cannulation has been widely used because of lower technical failure rate and complications, and faster access compared with landmark-guided cannulation. Real-time guidance is more complex to perform and time-consuming in comparison to pre-scan technique. Therefore, real-time guidance should be reserved to specific groups, such as infants, children, or those with anatomical abnormality. However, there's no widely accepted ultrasound pre-scan techniques yet. The aim of this study is to define a simple, safe, and effective ultrasound pre-scan technique for right internal jugular vein (RIJV) cannulation.
Patient position for RIJV cannulation was reviewed in detail. First, 15ﾟ Trendelenburg tilt significantly increases the diameter of right internal jugular vein. Second, extreme head rotation to the opposite side will increase the overlap percentage between IJV and common carotid artery (CCA), but neutral head position might make the procedure difficult. Neutral head position or small degree (≦15ﾟ) of head rotation was recommended. Third, although shoulder roll is not recommended since it decreases the anterior-posterior diameter of RIJV, 4- to 5cm-high shoulder roll could be used to reduce the overlap if needed10. In conclusion, patients should be positioned by a 15ﾟ Trendelenburg tilt and 15ﾟ head rotation to the opposite side without a shoulder roll unless the IJV is anterior to CCA, which was termed as the rule of 15 by the research team.
After placing the patient properly, the operator puts a linear ultrasound probe at the mid neck in short-axis view. With IVJ in the center of the screen, marks at both ends of the transducer (mark A and B) are made. Then the operator rotates transducer 90 degrees counterclockwise. After finding IJV in long-axis view with transducer vertical to the ground, other two marks are made at both ends of the transducer (mark C and D), and transducer and jelly are removed. Then the operator sterilizes the performing field with chlorhexidine without removing the marks. After proper preparation and recognizing the cross point made by the imagined lines of marks AB and marks CD (point E), the operator inserts the needle vertically to the ground at point E.
The aim of this study is to compare the effectiveness and safety between ultrasound pre-scan technique and traditional landmark-guidance. Inclusion criteria are adult patients receiving general anesthesia in need of central venous cannulation. The primary endpoint is the number of needle redirection, and secondary endpoints include first attempt success rate, artery puncture, complication, number of wire attempt, number of skin insertion, venous access time, catheterization time, and malposition. The hypothesis is that the ultrasound pre-scan method would have a fewer number of needle redirection, a higher first-attempt success rate, as well as less complication, number of redirection.
- Conditions
- Anesthesia
- Being tested
- Ultrasound pre-scan, Landmark guidance
- Keywords
- Ultrasound, pre-scan, right internal jugular vein
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound pre-scanProcedure or surgery
Before cannulation, use ultrasound to mark the position of right internal jugular vein
Landmark guidanceProcedure or surgery
The traditional landmark-guided technique for internal jugular vein cannulation, including recognizing the sternocleidomastoid muscle and palpating the carotid artery
| Study group | Role | What they receive |
|---|---|---|
| ultrasound pre-scan group | Experimental | Perform ultrasound pre-scan before central venous cannulation Receives: Procedure: Ultrasound pre-scan |
| landmark guidance group | Sham comparator | Use the traditional landmark method to perform central venous cannulation Receives: Procedure: Landmark guidance |
What is being measured
The primary outcome is the main question the study is designed to answer.
number of needle redirection
How many times of the needle being withdrawn and redirected before successfully access internal jugular vein
Measured: During the cannulation procedure
Secondary outcomes (9)
first attempt success rate
successfully access the internal jugular vein at first attempt
Measured: During the cannulation procedure
artery puncture
accidental artery puncture
Measured: During the cannulation procedure
number of wire attempt
how many times of the wire attempts before successful wire insertion to internal jugular vein
Measured: During the cannulation procedure
number of skin insertion
how many different skin insertion sites were tried before successfully access the internal jugular vein
Measured: During the cannulation procedure
venous access time
How long does it take from the first skin insertion to success venous access
Measured: During the cannulation procedure
catheterization time
How long does it take from the first skin insertion to successful catheter cannulation
Measured: During the cannulation procedure
malposition
the catheter misplaced to wrong sites (e.g. artery, subcutaneous)
Measured: During the cannulation procedure
presence of hematoma
a different and blinded investigator reviewed the post-procedure ultrasound image to determine whether there is hematoma after the procedure
Measured: immediately at the end of procedure, evaluated by clinical signs and ultrasound image
other complication
Other complications related to the procedure, such as pneumothorax
Measured: during the procedure, and 1 day after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2020
- Study startFeb 2020 (estimated)
- Primary completionDec 2020 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AnesthesiaStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taipei Medical University WanFang Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jui-An Lin, Dr., Study chair, Doctor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04224259
- Sponsor's protocol ID
- N201803005
- Status last verified
- Dec 2019
- First submitted
- 28 Oct 2019
- Last updated
- 13 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There's no plan of sharing individual participant data currently
Publications
Schummer W, Koditz JA, Schelenz C, Reinhart K, Sakka SG. Pre-procedure ultrasound increases the success and safety of central venous catheterizationdagger. Br J Anaesth. 2014 Jul;113(1):122-9. doi: 10.1093/bja/aeu049. Epub 2014 Mar 18.
PubMed 24648131
Study at a glance
From the registry record, last updated by the sponsor on 13 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utility of Vertical Puncture Technique Assisted by Ultrasound Pre-scan to Reduce Needle Redirection During Right Jugular Vein Cannulation
- ClinicalTrials.gov ID
- NCT04224259
- Acronym / sponsor ID
- N201803005
- Conditions
- Anesthesia
- Keywords
- Ultrasound, pre-scan, right internal jugular vein
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Taipei Medical University WanFang HospitalUniversity, hospital or other
- Study start
- Feb 2020 (estimated)
- Primary completion
- Dec 2020 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 13 Jan 2020 (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.
This study aims to define a simple, safe, and effective ultrasound pre-scan technique for right internal jugular vein (RIJV) cannulation. After placing the patient properly, the operator puts a linear ultrasound probe at the mid neck in short-axis view. With the IVJ in the center of the screen, the operator makes marks at both ends of the transducer (mark A and B), and then rotates the transducer 90 degrees counterclockwise. After finding IJV in long-axis view with transducer vertical to the ground, other two marks are made at both ends of the transducer (mark C and D). After proper preparation, the operator recognizes the cross point made by the imagined lines of marks AB and marks CD (point E). The needle is inserted vertically to the ground at point E.
Inclusion criteria are adult patients receiving general anesthesia in need of central venous cannulation.The primary endpoint is the number of needle redirection, and secondary endpoints include first attempt success rate, artery puncture, complication, number of wire attempt, number of skin insertion, venous access time, catheterization time, and malposition. The hypothesis is that this ultrasound pre-scan method would have a fewer number of needle redirection, a higher first-attempt success rate, as well as less complication, number of redirection.
Detailed description
Ultrasound-guided central venous cannulation has been widely used because of lower technical failure rate and complications, and faster access compared with landmark-guided cannulation. Real-time guidance is more complex to perform and time-consuming in comparison to pre-scan technique. Therefore, real-time guidance should be reserved to specific groups, such as infants, children, or those with anatomical abnormality. However, there's no widely accepted ultrasound pre-scan techniques yet. The aim of this study is to define a simple, safe, and effective ultrasound pre-scan technique for right internal jugular vein (RIJV) cannulation.
Patient position for RIJV cannulation was reviewed in detail. First, 15ﾟ Trendelenburg tilt significantly increases the diameter of right internal jugular vein. Second, extreme head rotation to the opposite side will increase the overlap percentage between IJV and common carotid artery (CCA), but neutral head position might make the procedure difficult. Neutral head position or small degree (≦15ﾟ) of head rotation was recommended. Third, although shoulder roll is not recommended since it decreases the anterior-posterior diameter of RIJV, 4- to 5cm-high shoulder roll could be used to reduce the overlap if needed10. In conclusion, patients should be positioned by a 15ﾟ Trendelenburg tilt and 15ﾟ head rotation to the opposite side without a shoulder roll unless the IJV is anterior to CCA, which was termed as the rule of 15 by the research team.
After placing the patient properly, the operator puts a linear ultrasound probe at the mid neck in short-axis view. With IVJ in the center of the screen, marks at both ends of the transducer (mark A and B) are made. Then the operator rotates transducer 90 degrees counterclockwise. After finding IJV in long-axis view with transducer vertical to the ground, other two marks are made at both ends of the transducer (mark C and D), and transducer and jelly are removed. Then the operator sterilizes the performing field with chlorhexidine without removing the marks. After proper preparation and recognizing the cross point made by the imagined lines of marks AB and marks CD (point E), the operator inserts the needle vertically to the ground at point E.
The aim of this study is to compare the effectiveness and safety between ultrasound pre-scan technique and traditional landmark-guidance. Inclusion criteria are adult patients receiving general anesthesia in need of central venous cannulation. The primary endpoint is the number of needle redirection, and secondary endpoints include first attempt success rate, artery puncture, complication, number of wire attempt, number of skin insertion, venous access time, catheterization time, and malposition. The hypothesis is that the ultrasound pre-scan method would have a fewer number of needle redirection, a higher first-attempt success rate, as well as less complication, number of redirection.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ultrasound pre-scan group | Experimental | Procedure: Ultrasound pre-scanPerform ultrasound pre-scan before central venous cannulation |
| landmark guidance group | Sham comparator | Procedure: Landmark guidanceUse the traditional landmark method to perform central venous cannulation |
Who may qualify
- Ages
- 20 to 79 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Older than 20 years and younger than 80 years of age
- American Society of Anesthesiologists Physical Status Classification I-III (no immediate life-threatening condition)
- Scheduled for regular surgery
- Receive general anesthesia with endotracheal tube intubation
- In need of central venous catheter placement
Key exclusion criteria (4 listed)
- Body Mass Index > 35kg/m^2
- Abnormal anatomy of the neck
- Limited range of motion of the neck
- The surgery does not allow right internal jugular vein cannulation or other contraindications for the procedure
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 |
|---|---|---|
| Ultrasound pre-scanBefore cannulation, use ultrasound to mark the position of right internal jugular vein | Procedure or surgery | ultrasound pre-scan group |
| Landmark guidanceThe traditional landmark-guided technique for internal jugular vein cannulation, including recognizing the sternocleidomastoid muscle and palpating the carotid artery | Procedure or surgery | landmark guidance group |
Primary outcome
number of needle redirection
Time frame: During the cannulation procedure
How many times of the needle being withdrawn and redirected before successfully access internal jugular vein
9 secondary outcomes
first attempt success rate
Time frame: During the cannulation procedure
artery puncture
Time frame: During the cannulation procedure
number of wire attempt
Time frame: During the cannulation procedure
number of skin insertion
Time frame: During the cannulation procedure
venous access time
Time frame: During the cannulation procedure
catheterization time
Time frame: During the cannulation procedure
malposition
Time frame: During the cannulation procedure
presence of hematoma
Time frame: immediately at the end of procedure, evaluated by clinical signs and ultrasound image
other complication
Time frame: during the procedure, and 1 day after the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jan 2020.
- Background: PubMed 24648131Schummer W, Koditz JA, Schelenz C, Reinhart K, Sakka SG. Pre-procedure ultrasound increases the success and safety of central venous catheterizationdagger. Br J Anaesth. 2014 Jul;113(1):122-9. doi: 10.1093/bja/aeu049. Epub 2014 Mar 18.
- Individual participant dataSharing planned: No. There's no plan of sharing individual participant data currently
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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.
Jui-An Lin, Dr. study chair
Doctor
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound pre-scan and Landmark guidance in people with Anesthesia, run by Taipei Medical University WanFang Hospital.
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 5 inclusion and 4 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 13 Jan 2020. 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. Some participants in this study may receive a placebo. 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 Wei-Chen Chung, Dr. (+886965562781, elizabethp215@yahoo.com.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of needle redirection (time frame: During the cannulation procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04224259, which also lists 1 linked publication.
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 13 Jan 2020.