Catheterization, Central VenousNCT04840810
To Compare the In-plane and Out of Plane Ultrasound Guided Approach for Internal Jugular Vein Cannulation in the Patients Undergoing Elective Cardiac Surgery.
A study testing In-plane Axis and Out of plane Axis in people with Catheterization, Central Venous and Ultrasonography, run by Aga Khan University Hospital, Pakistan at 1 site in Pakistan.
Trial summary
The insertion of central venous catheters (CVCs) has become an integral part of management of a critically ill patient. Access to the central vein may be required for the administration of hyper osmotic or vasoactive compounds, parenteral nutrition, and rapid infusion of large volumes of fluid or for the continuous or… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Catheterization, Central Venous, Ultrasonography, Cardiac Surgical Procedures
- What is being tested?
- In-plane Axis and Out of plane Axis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2019to 2 Apr 2019
- 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Patients admitted for elective cardiac surgery.
- Age between 18 - 75 years.
Who cannot join
- BMI more than 30.
- Haemodynamically unstable.
- Patient with abnormal coagulation profile(INR>1.5 or Platelet counts<50,000).
- Patient with a short neck.
- Patient with carotid Atherosclerosis proven on ultrasound.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: To Compare the In-plane and Out of Plane Ultrasound Guided Approach for Internal Jugular Vein Cannulation in the Patients Undergoing Elective Cardiac Surgery. A Prospective Randomize Control Trial.
The insertion of central venous catheters (CVCs) has become an integral part of management of a critically ill patient. Access to the central vein may be required for the administration of hyper osmotic or vasoactive compounds, parenteral nutrition, and rapid infusion of large volumes of fluid or for the continuous or intermittent monitoring of biochemical or physiological parameters. Central venous catheter insertion is also indicated when the insertion of a peripheral line is not possible. Traditionally, CVC insertions have been performed using the landmark technique.
Considering the number of CVCs being inserted every day, this can amount to a large number of complications. Efforts to minimize and prevent the occurrence of complications should be a routine component of quality improvement programs. There is an increasing body of evidence supporting the use of ultrasound guidance for CVC placement.
This makes the strong rationale to conduct this research thus the aim of this study is to evaluate the real benefits i.e outcome of Long versus Short Axis ultrasound guided approach for internal jugular vein cannulation in the patient for elective cardiac surgery as central venous cannulation (CVC).
Read the detailed description
OBJECTIVE: To compare the in plane and out of plane ultrasound guided approach for internal jugular vein cannulation in the patients undergoing elective cardiac surgery.
Ultrasound-guided central vein cannulation has many advantages, giving the operator the possibility of choosing the most appropriate and safest venous access on the basis of ultrasound assessment, performing a 100% safe insertion, ruling out malposition or pleuropulmonary damages, during and after the procedure.
There is an increasing body of evidence supporting the use of ultrasound guidance for CVC placement.
This makes the strong rationale to conduct this research thus the aim of this study is to evaluate the real benefits i.e outcome of Long versus Short Axis ultrasound guided approach for internal jugular vein cannulation in the patient for elective cardiac surgery as central venous cannulation (CVC).
- Being tested
- In-plane Axis, Out of plane Axis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-plane AxisProcedure or surgery
In a long-axis view, the image plane is parallel to the course of the vessel (needle is "in-plane"). The image shows the course of the vessel across the screen and the shaft and point of the needle as it is advanced. The central venous cannulation was done in in-plane axis.
Out of plane AxisProcedure or surgery
In a short-axis view, the image plane is perpendicular to the course of the vessel and to the needle (needle is "out of plane"). The vessel appears as an anechoic circle on the screen of ultrasound with the needle visualized as a hyperechoic point in cross-section. The central venous cannulation was done in out of plane axis.
| Study group | Role | What they receive |
|---|---|---|
| Out of plane/ short axis central venous cannulation | Active comparator | In a short-axis view, the image plane is perpendicular to the course of the vessel and to the needle (needle is "out of plane"). The vessel appears as an anechoic circle on the screen of ultrasound with the needle visualized as a hyperechoic point in cross-section. The central venous cannulation was done in out of plane axis. Receives: Procedure: In-plane Axis |
| In-plane/long axis central venous cannulation | Active comparator | In a long-axis view, the image plane is parallel to the course of the vessel (needle is "in-plane"). The image shows the course of the vessel across the screen and the shaft and point of the needle as it is advanced. The central venous cannulation was done in in-plane axis. Receives: Procedure: Out of plane Axis |
What is being measured
The primary outcome is the main question the study is designed to answer.
First pass success Rate
Recoded in percentage. Needle successfully inserted into the internal jugular vein and there is no need of Readjustment
Measured: immediately after end of procedure
Duration of procedure
Recorded in seconds
Measured: Intraoperative (after skin prick to ultrasound confirmation of presence of guide wire within internal jugular vein)
Secondary outcomes (1)
Unintentional carotid puncture
Recorded in percentage
Measured: immediately after completion of procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2021
- Study start1 Jan 2019
- Primary completion30 Mar 2019
- Study completion2 Apr 2019
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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aga Khan University Hospital, Pakistan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Rizwana Shehzad, Aga Khan University Hospital, Pakistan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04840810
- Sponsor's protocol ID
- AgaKhanUH
- Status last verified
- Apr 2021
- First submitted
- 8 Apr 2021
- Last updated
- 13 Apr 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schummer W, Schummer C, Rose N, Niesen WD, Sakka SG. Mechanical complications and malpositions of central venous cannulations by experienced operators. A prospective study of 1794 catheterizations in critically ill patients. Intensive Care Med. 2007 Jun;33(6):1055-9. doi: 10.1007/s00134-007-0560-z. Epub 2007 Mar 7.
PubMed 17342519Jefferson P, Ogbue MN, Hamilton KE, Ball DR. A survey of the use of portable ultrasound for central vein cannulation on critical care units in the UK. Anaesthesia. 2002 Apr;57(4):365-8. doi: 10.1046/j.1365-2044.2002.02319.x.
PubMed 11939995Randolph AG, Cook DJ, Gonzales CA, Pribble CG. Ultrasound guidance for placement of central venous catheters: a meta-analysis of the literature. Crit Care Med. 1996 Dec;24(12):2053-8. doi: 10.1097/00003246-199612000-00020.
PubMed 8968276
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Compare the In-plane and Out of Plane Ultrasound Guided Approach for Internal Jugular Vein Cannulation in the Patients Undergoing Elective Cardiac Surgery. A Prospective Randomize Control Trial.
- ClinicalTrials.gov ID
- NCT04840810
- Acronym / sponsor ID
- AgaKhanUH
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Aga Khan University Hospital, PakistanUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 30 Mar 2019 (actual)
- Study completion
- 2 Apr 2019 (actual)
- First posted
- 12 Apr 2021 (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.
The insertion of central venous catheters (CVCs) has become an integral part of management of a critically ill patient. Access to the central vein may be required for the administration of hyper osmotic or vasoactive compounds, parenteral nutrition, and rapid infusion of large volumes of fluid or for the continuous or intermittent monitoring of biochemical or physiological parameters. Central venous catheter insertion is also indicated when the insertion of a peripheral line is not possible. Traditionally, CVC insertions have been performed using the landmark technique.
Considering the number of CVCs being inserted every day, this can amount to a large number of complications. Efforts to minimize and prevent the occurrence of complications should be a routine component of quality improvement programs. There is an increasing body of evidence supporting the use of ultrasound guidance for CVC placement.
This makes the strong rationale to conduct this research thus the aim of this study is to evaluate the real benefits i.e outcome of Long versus Short Axis ultrasound guided approach for internal jugular vein cannulation in the patient for elective cardiac surgery as central venous cannulation (CVC).
Detailed description
OBJECTIVE: To compare the in plane and out of plane ultrasound guided approach for internal jugular vein cannulation in the patients undergoing elective cardiac surgery.
Ultrasound-guided central vein cannulation has many advantages, giving the operator the possibility of choosing the most appropriate and safest venous access on the basis of ultrasound assessment, performing a 100% safe insertion, ruling out malposition or pleuropulmonary damages, during and after the procedure.
There is an increasing body of evidence supporting the use of ultrasound guidance for CVC placement.
This makes the strong rationale to conduct this research thus the aim of this study is to evaluate the real benefits i.e outcome of Long versus Short Axis ultrasound guided approach for internal jugular vein cannulation in the patient for elective cardiac surgery as central venous cannulation (CVC).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Out of plane/ short axis central venous cannulation | Active comparator | Procedure: In-plane AxisIn a short-axis view, the image plane is perpendicular to the course of the vessel and to the needle (needle is "out of plane"). The vessel appears as an anechoic circle on the screen of ultrasound with the needle visualized as a hyperechoic point in cross-section. The central venous cannulation was done in out of plane axis. |
| In-plane/long axis central venous cannulation | Active comparator | Procedure: Out of plane AxisIn a long-axis view, the image plane is parallel to the course of the vessel (needle is "in-plane"). The image shows the course of the vessel across the screen and the shaft and point of the needle as it is advanced. The central venous cannulation was done in in-plane axis. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients admitted for elective cardiac surgery.
- Age between 18 - 75 years.
Key exclusion criteria (5 listed)
- BMI more than 30.
- Haemodynamically unstable.
- Patient with abnormal coagulation profile(INR>1.5 or Platelet counts<50,000).
- Patient with a short neck.
- Patient with carotid Atherosclerosis proven on ultrasound.
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 |
|---|---|---|
| In-plane AxisIn a long-axis view, the image plane is parallel to the course of the vessel (needle is "in-plane"). The image shows the course of the vessel across the screen and the shaft and point of the needle as it is advanced. The central venous cannulation was done in in-plane axis. | Procedure or surgery | Out of plane/ short axis central venous cannulation |
| Out of plane AxisIn a short-axis view, the image plane is perpendicular to the course of the vessel and to the needle (needle is "out of plane"). The vessel appears as an anechoic circle on the screen of ultrasound with the needle visualized as a hyperechoic point in cross-section. The central venous cannulation was done in out of plane axis. | Procedure or surgery | In-plane/long axis central venous cannulation |
Primary outcome
First pass success Rate
Time frame: immediately after end of procedure
Recoded in percentage. Needle successfully inserted into the internal jugular vein and there is no need of Readjustment
Duration of procedure
Time frame: Intraoperative (after skin prick to ultrasound confirmation of presence of guide wire within internal jugular vein)
Recorded in seconds
1 secondary outcome
Unintentional carotid puncture
Time frame: immediately after completion of procedure
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 13 Apr 2021.
- Background: PubMed 17342519Schummer W, Schummer C, Rose N, Niesen WD, Sakka SG. Mechanical complications and malpositions of central venous cannulations by experienced operators. A prospective study of 1794 catheterizations in critically ill patients. Intensive Care Med. 2007 Jun;33(6):1055-9. doi: 10.1007/s00134-007-0560-z. Epub 2007 Mar 7.
- Background: PubMed 11939995Jefferson P, Ogbue MN, Hamilton KE, Ball DR. A survey of the use of portable ultrasound for central vein cannulation on critical care units in the UK. Anaesthesia. 2002 Apr;57(4):365-8. doi: 10.1046/j.1365-2044.2002.02319.x.
- Background: PubMed 8968276Randolph AG, Cook DJ, Gonzales CA, Pribble CG. Ultrasound guidance for placement of central venous catheters: a meta-analysis of the literature. Crit Care Med. 1996 Dec;24(12):2053-8. doi: 10.1097/00003246-199612000-00020.
- Individual participant dataSharing planned: No
Related trials for Catheterization, Central Venous
RecruitingObservational study
Frailty and Ultrasound-Guided Central Venous Catheterization Difficulty in Adult Cardiac Surgery Patients
Frailty, Cardiac Surgery
Enrolling by invitationObservational study
Ultrasound Guidance vs Landmark Technique for Internal Jugular Vein Catheterization
Central Vein Catheter, Ultrasound
Enrolling by invitationObservational study
Ultrasound Guidance vs. Landmark Technique for Catheter Malposition in IJV Catheterization
Catheter Malposition, Central Venous Catheterization
Not yet recruitingObservational study
Ultrasound Assessment of Internal Jugular Vein for Cannulation and Venous Pressure Prediction
Vascular Access, Elevated Jugular Venous Pressure
Active, not recruitingObservational study
Effect of Central Venous Catheterization on Brain Pressure in Acute Brain Injury Patients
Acute Brain Injury, Traumatic Brain Injury
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 In-plane Axis and Out of plane Axis in people with Catheterization, Central Venous and Ultrasonography, 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 2 inclusion and 5 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 13 Apr 2021. 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?
First pass success Rate (time frame: immediately after end of procedure). The study lists 2 primary outcomes in all. 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 NCT04840810, 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 13 Apr 2021.