- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02185664
Use of Static Ultrasound Guidance for Internal Jugular Vein Cannulation in Adult Cardiac Surgical Patients
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Delhi
-
New Delhi, Delhi, India, 110002
- Department of Anesthesia and Intensive Care, Govind Ballabh Pant Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- adult patients scheduled for elective cardiac surgery
Exclusion Criteria:
- 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)
Study Plan
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Landmark technique
The landmark technique is the standard technique used for internal jugular vein cannulation.
|
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.
|
Experimental: Static Ultrasound technique
Static ultrasound technique was used to assist internal jugular vein cannulation.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
success
Time Frame: during internal jugular venous cannulation
|
Success was defined as location of the IJV by the finder needle within five attempts.
|
during internal jugular venous cannulation
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
number of attempts by finder/locator needle
Time Frame: at the time of internal jugular vein cannulation
|
The total number of attempts taken to locate the internal jugular vein using the locator/finder needle were measured.
|
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
|
The total number of attempts taken by the puncture needle to enter the internal jugular vein were measured.
|
at the time of internal jugular vein cannulation
|
First attempt sucess
Time Frame: at the time of internal jugular vein cannulation
|
First attempt success was defined as location of the IJV by finder needle in the first attempt.
|
at the time of internal jugular vein cannulation
|
Central venous cannulation time
Time Frame: at the time of internal jugular venous cannulation
|
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.
|
at the time of internal jugular venous cannulation
|
ultrasound time
Time Frame: at the time of internal jugular vein cannulation
|
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.
|
at the time of internal jugular vein cannulation
|
total cannulation time
Time Frame: at the time of internal jugular vein cannulation
|
control group: total cannulation time= central venous cannulation time ultrasound group: total cannulation time= central venous cannulation time+ ultrasound time
|
at the time of internal jugular vein cannulation
|
complication rate
Time Frame: at the time of central venous cannulation
|
The complication rate was calculated as a percentage of the total number of complications with respect to the sample size
|
at the time of central venous cannulation
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Deepak Tempe, MD, Govind Ballabh pant Hospital and Maulana azad Medical College, New Delhi, India
Publications and helpful links
General 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.
- Bailey 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.
- Hind 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- F.2/IEC/MAMC/11/No.96
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Adult Cardiac Surgical Patients
-
University of California, Los AngelesCAS Medical Systems, Inc.CompletedCardiac Surgical PatientsUnited States
-
National Defense Medical Center, TaiwanCompletedElective Cardiac Surgical PatientsTaiwan
-
University of JordanCompleted
-
Nanjing First Hospital, Nanjing Medical UniversityRecruiting
-
University of Colorado, DenverCompleted
-
Nationwide Children's HospitalCompleted
-
Betsi Cadwaladr University Health BoardCompletedElective Surgical Patients
-
Poitiers University HospitalCompleted
-
Università Politecnica delle MarcheCompletedHigh-Risk Surgical PatientsItaly
-
University of TorontoUniversity Health Network, Toronto; MSH-UHN AMO Innovation FundActive, not recruiting
Clinical Trials on landmark technique
-
Xin Jiang, MDUnknown
-
Tobias TodsenOdense University HospitalUnknownPeritonsillar AbscessDenmark
-
Aga Khan University Hospital, PakistanCompleted
-
Equipo de Terapia IntravenosaHospital San Carlos, MadridCompleted
-
Children's Hospital of PhiladelphiaActive, not recruiting
-
Hackensack Meridian HealthWithdrawn
-
American University of Beirut Medical CenterCompleted
-
Rajiv Gandhi Cancer Institute & Research Center...Not yet recruitingAnatomic Landmarks | Intubation, IntratrachealIndia
-
Uludag UniversityNot yet recruiting
-
National Neuroscience InstituteHiCura Medical Pte LtdRecruitingUltrasound Therapy | Lumbar PunctureSingapore