Compare Central Line Insertion of Subclavian Vein With Two Different Approaches Using UltrasoundPhase 4NCT02925715
Comparative Evaluation of Ultrasound Guided Supraclavicular and Infraclavicular Subclavian Venous Catheterizations in Adult Patients Undergoing Major Surgeries
A Phase 4 study testing ultrasound guided central venous cannulation in people with Compare Central Line Insertion of Subclavian Vein With Two Different Approaches Using Ultrasound, run by Post Graduate Institute of Medical Education and Research, Chandigarh.
Trial summary
Comparison of two techniques of central venous cannulation of subclavian vein using ultrasound was performed. ultrasound guided central venous cannulation is the standard practice today but its use in subclavian vein is technically challenging and not much literature is available. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Compare Central Line Insertion of Subclavian Vein With Two Different Approaches Using Ultrasound
- What is being tested?
- ultrasound guided central venous cannulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 96 participants
- Where
- No sites listed yet
- Study dates
- Sep 2015to Aug 2016
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy adults requiring central venous cannulation.
Who cannot join
- History of prior catheterization.
- Limited sites for access attempts (other catheters, pacemaker, prior surgery).
- Previous difficulties during catheterization such as more than three punctures at one site, two sites attempted or failure to gain access.
- Previous mechanical complications during catheterization.
- Patients with infection at puncture site and contralateral pneumothorax.
- Patients with trauma to clavicle and upper ribs, distorted anatomy of neck or clavicles.
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- Cervical spine injury.
- Known vascular abnormality.
- Untreated coagulopathy such as International Normalization Ratio(INR) ≥ 2, activated partial thromboplastin time >1.5 of normal or platelets <50,000/mm3
- After 3 attempts at needle puncture.
About this study
Comparison of two techniques of central venous cannulation of subclavian vein using ultrasound was performed. ultrasound guided central venous cannulation is the standard practice today but its use in subclavian vein is technically challenging and not much literature is available. In this study 96 Patients were randomized into one of the groups and compared for various outcomes. The primary outcome studied was the time taken for procedure. Secondary objectives included comparison of total access time using both the techniques,comparison of first attempt success rate, comparison of the quality of needle visualization and the comparison of immediate (mechanical) and delayed complication rates.
- Conditions
- Compare Central Line Insertion of Subclavian Vein With Two Different Approaches Using Ultrasound
- Being tested
- ultrasound guided central venous cannulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound guided central venous cannulationProcedure or surgery
ultrasound is a medical device which is frequently used for safe venous punctures as you can visualise the structures.so, device ''ultrasound'' will be used for intervention ''central line insertion'' in subclavian vein. ultrasound guided cannulation of the subclavian vein was done by supraclavicular or infraclavicular approach after randomization into either of the two groups.In the supraclavicular approach the puncture site is above the clavicle while in the infraclavicular group the puncture site is below the clavicle. Central venous cannulation is done after identifying the vein on ultrasound and using standard seldinger technique with full asepsis.
| Study group | Role | What they receive |
|---|---|---|
| supraclavicular | Experimental | ultrasound guided central venous cannulation done by supraclavicular approach Receives: Procedure: ultrasound guided central venous cannulation |
| infraclavicular | Experimental | ultrasound guided central venous cannulation done by infraclavicular approach Receives: Procedure: ultrasound guided central venous cannulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
puncture time of subclavian vein using ultrasound-guided supraclavicular or infraclavicular approach infraclavicular approaches in adults
will be measured in seconds
Measured: 1 year
Secondary outcomes (4)
total time taken for cannulation of veins using both the techniques.
measured in seconds
Measured: 1 year
first attempt success rate
number of attempts taken will be measured
Measured: 1 year
quality of needle visualisation
subjective visualisation of the needle on ultrasound will be noted as good or poor
Measured: 1 year
immediate and delayed complications with the two approaches
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2016 (estimated)
- Study startSep 2015
- Primary completionAug 2016
- Study completionAug 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Compare Central Line Insertion of Subclavian Vein With Two Different Approaches Using UltrasoundStudies 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 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 96 participants (actual)
Sponsor and investigators
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, Chandigarh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Vikas Saini, Post Graduate Institute of Medical Education and Research, Chandigarh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02925715
- Sponsor's protocol ID
- INT/IEC/2015/321
- Status last verified
- Oct 2016
- First submitted
- 30 Sep 2016
- Last updated
- 10 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Evaluation of Ultrasound Guided Supraclavicular and Infraclavicular Subclavian Venous Catheterizations in Adult Patients Undergoing Major Surgeries
- ClinicalTrials.gov ID
- NCT02925715
- Acronym / sponsor ID
- INT/IEC/2015/321
- Conditions
- Compare Central Line Insertion of Subclavian Vein With Two Different Approaches Using Ultrasound
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 96 participants (actual)
- Lead sponsor
- Post Graduate Institute of Medical Education and Research, ChandigarhUniversity, hospital or other
- Study start
- Sep 2015
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 6 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.
Comparison of two techniques of central venous cannulation of subclavian vein using ultrasound was performed. ultrasound guided central venous cannulation is the standard practice today but its use in subclavian vein is technically challenging and not much literature is available. In this study 96 Patients were randomized into one of the groups and compared for various outcomes. The primary outcome studied was the time taken for procedure. Secondary objectives included comparison of total access time using both the techniques,comparison of first attempt success rate, comparison of the quality of needle visualization and the comparison of immediate (mechanical) and delayed complication rates.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| supraclavicular | Experimental | Procedure: ultrasound guided central venous cannulationultrasound guided central venous cannulation done by supraclavicular approach |
| infraclavicular | Experimental | Procedure: ultrasound guided central venous cannulationultrasound guided central venous cannulation done by infraclavicular approach |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy adults requiring central venous cannulation.
Key exclusion criteria (10 listed)
- History of prior catheterization.
- Limited sites for access attempts (other catheters, pacemaker, prior surgery).
- Previous difficulties during catheterization such as more than three punctures at one site, two sites attempted or failure to gain access.
- Previous mechanical complications during catheterization.
- Patients with infection at puncture site and contralateral pneumothorax.
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 guided central venous cannulationultrasound is a medical device which is frequently used for safe venous punctures as you can visualise the structures.so, device ''ultrasound'' will be used for intervention ''central line insertion'' in subclavian vein. ultrasound guided cannulation of the subclavian vein was done by supraclavicular or infraclavicular approach after randomization into either of the two groups.In the supraclavicular approach the puncture site is above the clavicle while in the infraclavicular group the puncture site is below the clavicle. Central venous cannulation is done after identifying the vein on ultrasound and using standard seldinger technique with full asepsis. | Procedure or surgery | infraclavicular, supraclavicular |
Primary outcome
puncture time of subclavian vein using ultrasound-guided supraclavicular or infraclavicular approach infraclavicular approaches in adults
Time frame: 1 year
will be measured in seconds
4 secondary outcomes
total time taken for cannulation of veins using both the techniques.
Time frame: 1 year
first attempt success rate
Time frame: 1 year
quality of needle visualisation
Time frame: 1 year
immediate and delayed complications with the two approaches
Time frame: 1 year
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 10 Oct 2016.
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 Phase 4 study testing ultrasound guided central venous cannulation in people with Compare Central Line Insertion of Subclavian Vein With Two Different Approaches Using Ultrasound, run by Post Graduate Institute of Medical Education and Research, Chandigarh.
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 10 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 10 Oct 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
puncture time of subclavian vein using ultrasound-guided supraclavicular or infraclavicular approach infraclavicular approaches in adults (time frame: 1 year). 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 10 Oct 2016.