UltrasonographyNCT03130660
Short Versus Long Axis Ultrasound Guided Approach for Internal Jugular Vein Cannulations
A study testing Ultrasonography in people with Ultrasonography and Central Line Complication, run by Institute of Medical Sciences and SUM Hospital at 1 site in India.
Trial summary
We plan to compare single person short axis view with two person long axis view Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Ultrasonography, Central Line Complication
- What is being tested?
- Ultrasonography
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteIndia
- Study dates
- 20 Apr 2017to 19 Apr 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Any patient getting admitted to ICU and requiring central venous cannulations.
Who cannot join
- Lack of consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Short Versus Long Axis Ultrasound Guided Approach for Internal Jugular Vein Cannulations: A Prospective Randomised Controlled Trial.
We plan to compare single person short axis view with two person long axis view
Read the detailed description
Introduction: The guidelines for the use of bedside ultrasonography in the evaluation of critically ill patients published by the society of critical care medicine recommends short-axis view be used during insertion of central venous catheter (CVC) in internal jugular vein (IJV) to improve success rate1. The long axis view is considered better for cannulations as it helps in preventing posterior wall puncture but in the trials it has been found to be inconvenient for a single user2,3. We hypothesise that if two persons perform long axis cannulations i.e. one person will image the vein while the other punctures it will be equally convenient to single person doing the cannulations in short axis. The advantage we expect to see is lesser complications in long axis group.
Methodology:
Inclusion criteria: Any patient getting admitted to ICU and requiring central venous cannulations.
Exclusion: Lack of consent. Randomization: At a 1:1 ratio, to be achieved using a computer-generated random number sequence for 100 consecutive subjects Study intervention: Eligible patients will be randomized to a short-axis or long axis technique for ultrasound guided IJV cannulations. Ultrasound guidance will be performed dynamically using a single-operator technique for short axis and double operator technique for long axis view. Cannulations and USG is to be carried out by 2 trained Anaesthesiologists.
Definition:
- Insertion time: Time taken from 1st puncture of skin to insertion of guide wire into the vein.
- Total Procedure time: Time from when Ultrasound scan was started to complete suturing of the CVC line.
- Number of needle sticks: Number of time punctures were done in the skin. Complications were noted as hematoma formation, posterior wall puncture, arterial puncture, extravasations of blood and pneumothorax.
All the times are to be noted by a bedside nurse who is not involved in the trial or knows the study hypothesis.
Statistical Analysis: An intention-to-treat analysis was performed. Insertion time, overall procedure time and number of needle sticks, and will be compared using Mann-Whitney U tests. The success rate and complication rate will be compared using Fisher exact tests. All statistical analyses will be performed with SPSS 20.0
- Conditions
- Ultrasonography, Central Line Complication
- Being tested
- Ultrasonography
- Keywords
- central line, Central Line Complication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasonographyDevice
Ultrasound guidance for central line
| Study group | Role | What they receive |
|---|---|---|
| Short Axis Ultrasonography | Experimental | one person does both ultrasound and line insertion Receives: Device: Ultrasonography |
| Long Axis Ultrasonography | Experimental | one person does ultrasound and another inserts the central line Receives: Device: Ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
time to insertion
time from skin puncture to insertion of guidewire
Measured: 15 minutes
Secondary outcomes (3)
Total Procedure time
Time from when Ultrasound scan was started to complete suturing of the CVC line.
Measured: 15 minutes
Number of needle sticks
Number of time punctures were done in the skin
Measured: 15 minutes
Complications
hematoma formation, posterior wall puncture, arterial puncture, extravasations of blood and pneumothorax
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2017
- Study start20 Apr 2017
- Primary completion19 Apr 2018
- Study completion19 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for UltrasonographyStudies 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
- Model description
- patient to be randomized to two groups
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Institute of Medical Sciences and SUM Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shakti Bedanta Mishra, Institute of Medical Sciences and SUM Hospital
- Investigators
- Arun Rath, MD, Study director, IMS and Sum hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03130660
- Sponsor's protocol ID
- DMR/IMS.SH/SOA/170022
- Status last verified
- Aug 2018
- First submitted
- 22 Apr 2017
- Last updated
- 8 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We havent decided yet
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Short Versus Long Axis Ultrasound Guided Approach for Internal Jugular Vein Cannulations: A Prospective Randomised Controlled Trial.
- ClinicalTrials.gov ID
- NCT03130660
- Acronym / sponsor ID
- DMR/IMS.SH/SOA/170022
- Conditions
- Ultrasonography, Central Line Complication
- Keywords
- central line, Central Line Complication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Institute of Medical Sciences and SUM HospitalUniversity, hospital or other
- Study start
- 20 Apr 2017 (actual)
- Primary completion
- 19 Apr 2018 (actual)
- Study completion
- 19 Apr 2018 (actual)
- First posted
- 26 Apr 2017 (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.
We plan to compare single person short axis view with two person long axis view
Detailed description
Introduction: The guidelines for the use of bedside ultrasonography in the evaluation of critically ill patients published by the society of critical care medicine recommends short-axis view be used during insertion of central venous catheter (CVC) in internal jugular vein (IJV) to improve success rate1. The long axis view is considered better for cannulations as it helps in preventing posterior wall puncture but in the trials it has been found to be inconvenient for a single user2,3. We hypothesise that if two persons perform long axis cannulations i.e. one person will image the vein while the other punctures it will be equally convenient to single person doing the cannulations in short axis. The advantage we expect to see is lesser complications in long axis group.
Methodology:
Inclusion criteria: Any patient getting admitted to ICU and requiring central venous cannulations.
Exclusion: Lack of consent. Randomization: At a 1:1 ratio, to be achieved using a computer-generated random number sequence for 100 consecutive subjects Study intervention: Eligible patients will be randomized to a short-axis or long axis technique for ultrasound guided IJV cannulations. Ultrasound guidance will be performed dynamically using a single-operator technique for short axis and double operator technique for long axis view. Cannulations and USG is to be carried out by 2 trained Anaesthesiologists.
Definition:
- Insertion time: Time taken from 1st puncture of skin to insertion of guide wire into the vein.
- Total Procedure time: Time from when Ultrasound scan was started to complete suturing of the CVC line.
- Number of needle sticks: Number of time punctures were done in the skin. Complications were noted as hematoma formation, posterior wall puncture, arterial puncture, extravasations of blood and pneumothorax.
All the times are to be noted by a bedside nurse who is not involved in the trial or knows the study hypothesis.
Statistical Analysis: An intention-to-treat analysis was performed. Insertion time, overall procedure time and number of needle sticks, and will be compared using Mann-Whitney U tests. The success rate and complication rate will be compared using Fisher exact tests. All statistical analyses will be performed with SPSS 20.0
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- patient to be randomized to two groups
| Arm | Type | Receives |
|---|---|---|
| Short Axis Ultrasonography | Experimental | Device: Ultrasonographyone person does both ultrasound and line insertion |
| Long Axis Ultrasonography | Experimental | Device: Ultrasonographyone person does ultrasound and another inserts the central line |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Any patient getting admitted to ICU and requiring central venous cannulations.
Key exclusion criteria (1 listed)
- Lack of consent
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 |
|---|---|---|
| UltrasonographyUltrasound guidance for central line | Device | Long Axis Ultrasonography, Short Axis Ultrasonography |
Primary outcome
time to insertion
Time frame: 15 minutes
time from skin puncture to insertion of guidewire
3 secondary outcomes
Total Procedure time
Time frame: 15 minutes
Number of needle sticks
Time frame: 15 minutes
Complications
Time frame: 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2018.
- Individual participant dataSharing planned: Undecided. We havent decided yet
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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.
Arun Rath, MD study director
IMS and Sum hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasonography in people with Ultrasonography and Central Line Complication, run by Institute of Medical Sciences and SUM Hospital at 1 site in India.
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: finished, as of the sponsor's last update on 8 Aug 2018. 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 India. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
time to insertion (time frame: 15 minutes). 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 8 Aug 2018; AzTrials last refreshed its copy on 6 Nov 2026.