Catheterization, Central VenousNCT05387486
Central Venous Catheter Insertion Techniques
A study testing Anatomical Landmark technique, Ultrasound-guided pre location technique and Ultrasound-guided real-time technique in people with Catheterization, Central Venous, run by Aga Khan University Hospital, Pakistan at 1 site in Pakistan.
Trial summary
Investigator compared three techniques of Central venous cannulation (CVC) insertion, Anatomical Landmark, Pre-location Ultrasound and the Real Ultrasound techniques, in cardiac surgical patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Catheterization, Central Venous
- What is being tested?
- Anatomical Landmark technique, Ultrasound-guided pre location technique and Ultrasound-guided real-time technique
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Aug 2019to 4 Jul 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 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years
- ASA (American society of Anesthesiologists) status 1 to 3 requiring central venous catheter during surgical procedure
- ASA (American society of Anesthesiologists) status 4 patients coming for cardiac surgery
Who cannot join
- Patients with a history of following
- Previous head and neck surgery
- Head and neck mass or cancer.
- Superior vena cava syndrome.
- Coagulopathy.
- Infection at the cannulation site.
Show all 12Show fewer
- Previous central venous access.
- Anatomical Changes due to surgery or any pathology in the neck which can lead to distortion of anatomical land marks in the region of puncture.
- Raised intracranial pressure (ICP).
- Patients coming for emergency surgery
- Patients with BMI (Body Mass Index) more than 30
- Patient refusal
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Internal Jugular Vein Cannulation: A Comparison Of Three Techniques: Anatomical Landmark, US Guided Prelocation, and Ultrasound Guided Real Time, at Tertiary Care Teaching University Hospital
Investigator compared three techniques of Central venous cannulation (CVC) insertion, Anatomical Landmark, Pre-location Ultrasound and the Real Ultrasound techniques, in cardiac surgical patients.
Read the detailed description
Central venous cannulation (CVC) is the cannulation of a large central vein in neck (internal jugular vein), chest (subclavian or axillary) or groin (femoral vein). It is a standard clinical method performed for the monitoring of central venous pressure, temporary haemodialysis, drug administration (drugs irritating peripheral veins, chemotherapy, concentrated vasoactive drugs ) rapid infusion of fluids, inadequate peripheral intravenous access and sampling site for repeated blood sampling. There are different techniques for Central venous cannulation which include anatomical landmark and ultrasound guided (USG) technique.
Previous studies have shown that the successful IJV cannulation using anatomical landmark technique was 85% as compared to ultrasound guided IJV cannulation which was 95%.The median catheterisation time of internal jugular vein via ultrasound guided (USG) is shorter than anatomical landmark technique.
There has been little evidence regarding the use of ultrasound guidance for internal jugular vein cannulation at a tertiary care hospital in our population. Furthermore with widespread availability of ultrasound, Internal Jugular vein can be successfully cannulated with decreasing number of attempts, less time consumption and decrease in the incidence of complications.
- Conditions
- Catheterization, Central Venous
- Being tested
- Anatomical Landmark technique, Ultrasound-guided pre location technique, Ultrasound-guided real-time technique
- Keywords
- Cardiac Surgery, Central Venous Catheter, Anatomical Landmark, Ultrasound
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anatomical Landmark techniqueProcedure or surgery
anatomical landmarks (sternocleidomastoid muscles, sternal notch, cricoid cartilage, carotid artery and clavicle) will be palpated. A 3cc syringe with 21 gauge needle (locator) will be used first to locate IJV at the apex of the triangle formed by the two heads of the sternocleidomastoid muscle. After successful location, an introducer needle of 18 gauge, attached with a 5 ml syringe, will be inserted at the same point. The introducer needle will be directed towards the ipsilateral nipple at an angle of 20-30° with the skin
Ultrasound-guided pre location techniqueProcedure or surgery
In Group Ultrasound-guided pre location technique, venipuncture site will be determined using ultrasound probe which will be then removed and locator needle of 21 gauge will be used first to confirm IJV location. The cannulation or venipuncture will be performed at the marked point of locator needle by the use of 18 gauge introducer needle.
Ultrasound-guided real-time techniqueProcedure or surgery
In Group Ultrasound-guided real-time technique, cannulation or venipuncture will be performed under real-time imaging using 18 gauge needle i-e ultrasound will be used for prelocation and puncturing of IJV and locator needle will not be used
| Study group | Role | What they receive |
|---|---|---|
| ALT | Active comparator | Not described Receives: Procedure: Anatomical Landmark technique |
| USG-Pre | Active comparator | Not described Receives: Procedure: Ultrasound-guided pre location technique |
| USG -RT | Active comparator | Not described Receives: Procedure: Ultrasound-guided real-time technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success Rate
Success rate will be measured according to the number of attempts. The cannulation of right Internal Jugular Vein within the first three attempts.
Measured: Day 1
Secondary outcomes (2)
Time duration for each technique
Measurment of time in minutes
Measured: Day 1
Incidence of Complications
Look for carotid puncture, haematoma formation , pneumothorax
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2022
- Study start1 Aug 2019
- Primary completion1 Apr 2021
- Study completion4 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Catheterization, Central VenousStudies 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
- Single blind
- Who is masked
- Participant
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University Hospital, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Syed Shabbir Ahmed, Aga Khan University Hospital, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05387486
- Sponsor's protocol ID
- 3488-Ane-ERC-15
- Status last verified
- Jul 2023
- First submitted
- 19 May 2022
- Last updated
- 1 Aug 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Ray BR, Mohan VK, Kashyap L, Shende D, Darlong VM, Pandey RK. Internal jugular vein cannulation: A comparison of three techniques. J Anaesthesiol Clin Pharmacol. 2013 Jul;29(3):367-71. doi: 10.4103/0970-9185.117115.
PubMed 24106363Leung J, Duffy M, Finckh A. Real-time ultrasonographically-guided internal jugular vein catheterization in the emergency department increases success rates and reduces complications: a randomized, prospective study. Ann Emerg Med. 2006 Nov;48(5):540-7. doi: 10.1016/j.annemergmed.2006.01.011. Epub 2006 Feb 21.
PubMed 17052555Kaye AD, Fox CJ, Hymel BJ, Gayle JA, Hawney HA, Bawcom BA, Cotter TD. The importance of training for ultrasound guidance in central vein catheterization. Middle East J Anaesthesiol. 2011 Feb;21(1):61-6.
PubMed 21991734
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Internal Jugular Vein Cannulation: A Comparison Of Three Techniques: Anatomical Landmark, US Guided Prelocation, and Ultrasound Guided Real Time, at Tertiary Care Teaching University Hospital
- ClinicalTrials.gov ID
- NCT05387486
- Acronym / sponsor ID
- 3488-Ane-ERC-15
- Conditions
- Catheterization, Central Venous
- Keywords
- Cardiac Surgery, Central Venous Catheter, Anatomical Landmark, Ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Aga Khan University Hospital, PakistanUniversity, hospital or other
- Study start
- 1 Aug 2019 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- 4 Jul 2021 (actual)
- First posted
- 24 May 2022 (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.
Investigator compared three techniques of Central venous cannulation (CVC) insertion, Anatomical Landmark, Pre-location Ultrasound and the Real Ultrasound techniques, in cardiac surgical patients.
Detailed description
Central venous cannulation (CVC) is the cannulation of a large central vein in neck (internal jugular vein), chest (subclavian or axillary) or groin (femoral vein). It is a standard clinical method performed for the monitoring of central venous pressure, temporary haemodialysis, drug administration (drugs irritating peripheral veins, chemotherapy, concentrated vasoactive drugs ) rapid infusion of fluids, inadequate peripheral intravenous access and sampling site for repeated blood sampling. There are different techniques for Central venous cannulation which include anatomical landmark and ultrasound guided (USG) technique.
Previous studies have shown that the successful IJV cannulation using anatomical landmark technique was 85% as compared to ultrasound guided IJV cannulation which was 95%.The median catheterisation time of internal jugular vein via ultrasound guided (USG) is shorter than anatomical landmark technique.
There has been little evidence regarding the use of ultrasound guidance for internal jugular vein cannulation at a tertiary care hospital in our population. Furthermore with widespread availability of ultrasound, Internal Jugular vein can be successfully cannulated with decreasing number of attempts, less time consumption and decrease in the incidence of complications.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ALT | Active comparator | Procedure: Anatomical Landmark technique |
| USG-Pre | Active comparator | Procedure: Ultrasound-guided pre location technique |
| USG -RT | Active comparator | Procedure: Ultrasound-guided real-time technique |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-65 years
- ASA (American society of Anesthesiologists) status 1 to 3 requiring central venous catheter during surgical procedure
- ASA (American society of Anesthesiologists) status 4 patients coming for cardiac surgery
Key exclusion criteria (12 listed)
- Patients with a history of following
- Previous head and neck surgery
- Head and neck mass or cancer.
- Superior vena cava syndrome.
- 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 |
|---|---|---|
| Anatomical Landmark techniqueanatomical landmarks (sternocleidomastoid muscles, sternal notch, cricoid cartilage, carotid artery and clavicle) will be palpated. A 3cc syringe with 21 gauge needle (locator) will be used first to locate IJV at the apex of the triangle formed by the two heads of the sternocleidomastoid muscle. After successful location, an introducer needle of 18 gauge, attached with a 5 ml syringe, will be inserted at the same point. The introducer needle will be directed towards the ipsilateral nipple at an angle of 20-30° with the skin | Procedure or surgery | ALT |
| Ultrasound-guided pre location techniqueIn Group Ultrasound-guided pre location technique, venipuncture site will be determined using ultrasound probe which will be then removed and locator needle of 21 gauge will be used first to confirm IJV location. The cannulation or venipuncture will be performed at the marked point of locator needle by the use of 18 gauge introducer needle. | Procedure or surgery | USG-Pre |
| Ultrasound-guided real-time techniqueIn Group Ultrasound-guided real-time technique, cannulation or venipuncture will be performed under real-time imaging using 18 gauge needle i-e ultrasound will be used for prelocation and puncturing of IJV and locator needle will not be used | Procedure or surgery | USG -RT |
Primary outcome
Success Rate
Time frame: Day 1
Success rate will be measured according to the number of attempts. The cannulation of right Internal Jugular Vein within the first three attempts.
2 secondary outcomes
Time duration for each technique
Time frame: Day 1
Incidence of Complications
Time frame: Day 1
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 1 Aug 2023.
- Background: PubMed 24106363Ray BR, Mohan VK, Kashyap L, Shende D, Darlong VM, Pandey RK. Internal jugular vein cannulation: A comparison of three techniques. J Anaesthesiol Clin Pharmacol. 2013 Jul;29(3):367-71. doi: 10.4103/0970-9185.117115.
- Background: PubMed 17052555Leung J, Duffy M, Finckh A. Real-time ultrasonographically-guided internal jugular vein catheterization in the emergency department increases success rates and reduces complications: a randomized, prospective study. Ann Emerg Med. 2006 Nov;48(5):540-7. doi: 10.1016/j.annemergmed.2006.01.011. Epub 2006 Feb 21.
- Background: PubMed 21991734Kaye AD, Fox CJ, Hymel BJ, Gayle JA, Hawney HA, Bawcom BA, Cotter TD. The importance of training for ultrasound guidance in central vein catheterization. Middle East J Anaesthesiol. 2011 Feb;21(1):61-6.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anatomical Landmark technique, Ultrasound-guided pre location technique and Ultrasound-guided real-time technique in people with Catheterization, Central Venous, run by Aga Khan University Hospital, Pakistan at 1 site in Pakistan.
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 3 inclusion and 12 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 1 Aug 2023. 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 Pakistan. 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?
Success Rate (time frame: Day 1). 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 NCT05387486, which also lists 3 linked publications.
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 1 Aug 2023.