Adult Cardiac Surgical PatientsNCT02185664
Use of Static Ultrasound Guidance for Internal Jugular Vein Cannulation in Adult Cardiac Surgical Patients
A study testing landmark technique and Static Ultrasound technique in people with Adult Cardiac Surgical Patients, run by Govind Ballabh Pant Hospital at 1 site in India.
Trial summary
Cannulation of the internal jugular vein (IJV) for central venous access is a standard practice in cardiac surgery. In this study, the authors tested the hypothesis that using an ultrasound (US) scanner would increase the success of IJV cannulation and decrease the incidence of complications in adult cardiac surgical… Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Adult Cardiac Surgical Patients
- What is being tested?
- landmark technique and Static Ultrasound technique
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 201 participants
- Where
- 1 siteIndia
- Study dates
- Apr 2011to Apr 2012
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- adult patients scheduled for elective cardiac surgery
Who cannot join
- patients undergoing bidirectional Glenn shunt, Fontan surgery or emergency surgery
- local site infection
- presence of coagulopathy
- anatomical deformity of neck(burns, neck swelling, surgical scar)
Trial locations and contacts
1 site in 1 country.
India1 site
Department of Anesthesia and Intensive Care, Govind Ballabh Pant Hospital
New Delhi, National Capital Territory of Delhi, 110002
About this study
Official title: Comparison of the Landmark Technique and the Static Ultrasound Guided Technique for Internal Jugular Vein Cannulation in Adult Cardiac Surgical Patients.
Cannulation of the internal jugular vein (IJV) for central venous access is a standard practice in cardiac surgery. In this study, the authors tested the hypothesis that using an ultrasound (US) scanner would increase the success of IJV cannulation and decrease the incidence of complications in adult cardiac surgical patients.
The study will include adult cardiac surgical patients, randomized into two groups (control vs. US). In the control group, IJV cannulation will be performed by the conventional landmark technique using Seldinger method. In the US group, the course of the IJV will be marked before cannulation using a 2 - 4 MHz transthoracic echocardiography probe. The success rate, number of attempts, cannulation time and complication rate will be compared for the two groups.
Read the detailed description
Use of real time ultrasound has recently been recommended as the standard of care for insertion of central venous catheters. However, its usage is limited by various factors which include availability, space constraints and perceived lack of need according to surveys including cardiovascular anesthesiologists. We will conduct a prospective randomized controlled trial to compare the conventional landmark technique with the static ultrasound (US) technique that utilized the transthoracic echocardiography (TTE) ultrasound probe which is supplied along with the transesophageal echocardiography machines for internal jugular vein cannulation in adult cardiac surgical patients.
After ethical committee approval and patient consent, adult patients scheduled for elective cardiac surgery will be randomized to undergo internal jugular vein cannulation by either of the two methods: standard landmark technique (group A: control group), static US technique using the TTE probe (group B: ultrasound group). The success rate, number of attempts, total cannulation time and complication rate in the two groups will be compared.
- Conditions
- Adult Cardiac Surgical Patients
- Being tested
- landmark technique, Static Ultrasound technique
- Keywords
- internal jugular vein, landmark, ultrasound, static, cardiac surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
landmark techniqueProcedure or surgery
The apex of the imaginary triangle formed between the two heads of sternocleidomastoid and clavicle was used as the point of needle entry, just lateral to the pulsation of the internal carotid artery and directed towards the ipsilateral nipple at an angle of 45 degrees.
Static Ultrasound techniqueDevice
Static ultrasound guided internal jugular vein cannulation was performed by using the transthoracic echocardiography probe supplied with the transesophageal echocardiography machine in the cardiothoracic surgery operation theatre. The internal jugular vein was located and marked using this method prior to puncture.
| Study group | Role | What they receive |
|---|---|---|
| Landmark technique | Active comparator | The landmark technique is the standard technique used for internal jugular vein cannulation. Receives: Procedure: landmark technique |
| Static Ultrasound technique | Experimental | Static ultrasound technique was used to assist internal jugular vein cannulation. Receives: Device: Static Ultrasound technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
success
Success was defined as location of the IJV by the finder needle within five attempts.
Measured: during internal jugular venous cannulation
Secondary outcomes (7)
number of attempts by finder/locator needle
The total number of attempts taken to locate the internal jugular vein using the locator/finder needle were measured.
Measured: at the time of internal jugular vein cannulation
total number of attempts by puncture needle
The total number of attempts taken by the puncture needle to enter the internal jugular vein were measured.
Measured: at the time of internal jugular vein cannulation
First attempt sucess
First attempt success was defined as location of the IJV by finder needle in the first attempt.
Measured: at the time of internal jugular vein cannulation
Central venous cannulation time
Time to central venous cannulation (CVC) was defined as the time taken from the insertion of finder needle till de-airing and flushing of all the three ports of the triple lumen catheter.
Measured: at the time of internal jugular venous cannulation
ultrasound time
The duration of ultrasound was defined as the time between the placement of the probe on neck till the marking of the course of the vein on the skin.
Measured: at the time of internal jugular vein cannulation
total cannulation time
control group: total cannulation time= central venous cannulation time ultrasound group: total cannulation time= central venous cannulation time+ ultrasound time
Measured: at the time of internal jugular vein cannulation
complication rate
The complication rate was calculated as a percentage of the total number of complications with respect to the sample size
Measured: at the time of central venous cannulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2014 (estimated)
- Study startApr 2011
- Primary completionApr 2012
- Study completionApr 2012
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 Adult Cardiac Surgical PatientsStudies 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
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 201 participants (actual)
Sponsor and investigators
- Lead sponsor
- Govind Ballabh Pant Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Dr Deepti Saigal, Govind Ballabh Pant Hospital
- Investigators
- Deepak Tempe, MD, Principal investigator, Govind Ballabh pant Hospital and Maulana azad Medical College, New Delhi, India
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02185664
- Sponsor's protocol ID
- F.2/IEC/MAMC/11/No.96
- Status last verified
- Jul 2014
- First submitted
- 4 Jul 2014
- Last updated
- 15 Jul 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Espinet A, Dunning J. Does ultrasound-guided central line insertion reduce complications and time to placement in elective patients undergoing cardiac surgery. Interact Cardiovasc Thorac Surg. 2004 Sep;3(3):523-7. doi: 10.1016/j.icvts.2004.05.006.
PubMed 17670301Bailey PL, Glance LG, Eaton MP, Parshall B, McIntosh S. A survey of the use of ultrasound during central venous catheterization. Anesth Analg. 2007 Mar;104(3):491-7. doi: 10.1213/01.ane.0000255289.78333.c2.
PubMed 17312193Hind D, Calvert N, McWilliams R, Davidson A, Paisley S, Beverley C, Thomas S. Ultrasonic locating devices for central venous cannulation: meta-analysis. BMJ. 2003 Aug 16;327(7411):361. doi: 10.1136/bmj.327.7411.361.
PubMed 12919984
Study at a glance
From the registry record, last updated by the sponsor on 15 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Landmark Technique and the Static Ultrasound Guided Technique for Internal Jugular Vein Cannulation in Adult Cardiac Surgical Patients.
- ClinicalTrials.gov ID
- NCT02185664
- Acronym / sponsor ID
- F.2/IEC/MAMC/11/No.96
- Conditions
- Adult Cardiac Surgical Patients
- Keywords
- internal jugular vein, landmark, ultrasound, static, cardiac surgery
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 201 participants (actual)
- Lead sponsor
- Govind Ballabh Pant HospitalOther government
- Study start
- Apr 2011
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 9 Jul 2014 (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.
Cannulation of the internal jugular vein (IJV) for central venous access is a standard practice in cardiac surgery. In this study, the authors tested the hypothesis that using an ultrasound (US) scanner would increase the success of IJV cannulation and decrease the incidence of complications in adult cardiac surgical patients.
The study will include adult cardiac surgical patients, randomized into two groups (control vs. US). In the control group, IJV cannulation will be performed by the conventional landmark technique using Seldinger method. In the US group, the course of the IJV will be marked before cannulation using a 2 - 4 MHz transthoracic echocardiography probe. The success rate, number of attempts, cannulation time and complication rate will be compared for the two groups.
Detailed description
Use of real time ultrasound has recently been recommended as the standard of care for insertion of central venous catheters. However, its usage is limited by various factors which include availability, space constraints and perceived lack of need according to surveys including cardiovascular anesthesiologists. We will conduct a prospective randomized controlled trial to compare the conventional landmark technique with the static ultrasound (US) technique that utilized the transthoracic echocardiography (TTE) ultrasound probe which is supplied along with the transesophageal echocardiography machines for internal jugular vein cannulation in adult cardiac surgical patients.
After ethical committee approval and patient consent, adult patients scheduled for elective cardiac surgery will be randomized to undergo internal jugular vein cannulation by either of the two methods: standard landmark technique (group A: control group), static US technique using the TTE probe (group B: ultrasound group). The success rate, number of attempts, total cannulation time and complication rate in the two groups will be compared.
Study design
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Landmark technique | Active comparator | Procedure: landmark techniqueThe landmark technique is the standard technique used for internal jugular vein cannulation. |
| Static Ultrasound technique | Experimental | Device: Static Ultrasound techniqueStatic ultrasound technique was used to assist internal jugular vein cannulation. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- adult patients scheduled for elective cardiac surgery
Key exclusion criteria (4 listed)
- patients undergoing bidirectional Glenn shunt, Fontan surgery or emergency surgery
- local site infection
- presence of coagulopathy
- anatomical deformity of neck(burns, neck swelling, surgical scar)
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 |
|---|---|---|
| landmark techniqueThe apex of the imaginary triangle formed between the two heads of sternocleidomastoid and clavicle was used as the point of needle entry, just lateral to the pulsation of the internal carotid artery and directed towards the ipsilateral nipple at an angle of 45 degrees. | Procedure or surgery | Landmark technique |
| Static Ultrasound techniqueStatic ultrasound guided internal jugular vein cannulation was performed by using the transthoracic echocardiography probe supplied with the transesophageal echocardiography machine in the cardiothoracic surgery operation theatre. The internal jugular vein was located and marked using this method prior to puncture. | Device | Static Ultrasound technique |
Primary outcome
success
Time frame: during internal jugular venous cannulation
Success was defined as location of the IJV by the finder needle within five attempts.
7 secondary outcomes
number of attempts by finder/locator needle
Time frame: at the time of internal jugular vein cannulation
total number of attempts by puncture needle
Time frame: at the time of internal jugular vein cannulation
First attempt sucess
Time frame: at the time of internal jugular vein cannulation
Central venous cannulation time
Time frame: at the time of internal jugular venous cannulation
ultrasound time
Time frame: at the time of internal jugular vein cannulation
total cannulation time
Time frame: at the time of internal jugular vein cannulation
complication rate
Time frame: at the time of central venous cannulation
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 15 Jul 2014.
- Background: PubMed 17670301Espinet A, Dunning J. Does ultrasound-guided central line insertion reduce complications and time to placement in elective patients undergoing cardiac surgery. Interact Cardiovasc Thorac Surg. 2004 Sep;3(3):523-7. doi: 10.1016/j.icvts.2004.05.006.
- Background: PubMed 17312193Bailey PL, Glance LG, Eaton MP, Parshall B, McIntosh S. A survey of the use of ultrasound during central venous catheterization. Anesth Analg. 2007 Mar;104(3):491-7. doi: 10.1213/01.ane.0000255289.78333.c2.
- Results publication: PubMed 12919984Hind D, Calvert N, McWilliams R, Davidson A, Paisley S, Beverley C, Thomas S. Ultrasonic locating devices for central venous cannulation: meta-analysis. BMJ. 2003 Aug 16;327(7411):361. doi: 10.1136/bmj.327.7411.361.
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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.
Deepak Tempe, MD principal investigator
Govind Ballabh pant Hospital and Maulana azad Medical College, New Delhi, India
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing landmark technique and Static Ultrasound technique in people with Adult Cardiac Surgical Patients, run by Govind Ballabh Pant 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 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: finished, as of the sponsor's last update on 15 Jul 2014. 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?
success (time frame: during internal jugular venous cannulation). 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 NCT02185664, 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 15 Jul 2014.