Heart; Surgery, Heart, Functional Disturbance as ResultNCT05656937
Oblique Versus Transverse Orientation Approach for Internal Jugular Venous Cannulation in Pediatrics
A study testing internal jugular venous cannulation in people with Heart; Surgery, Heart, Functional Disturbance as Result and Pediatric ALL, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
this study aimed to compare oblique versus transverse orientation approach in jugular venous cannulation in term of cannulation success in pediatric heart surgery patients Read more about this study
- Who is it for?
- Ages 3 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Heart; Surgery, Heart, Functional Disturbance as Result, Pediatric ALL
- What is being tested?
- internal jugular venous cannulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Feb 2021to 31 May 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 3 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- patients age 3 months to 12 years old, weight 5-20 kg, male or female
- who undergo heart surgery and indicated to have central venous cannulation
- American Society of Anesthesiologist Physical Class 1-3
- Family or representation of the patients agreed to participate in this study and sign informed consent
Who cannot join
- history of surgery in the area of cannulation
- already placed central venous cannulation <72 hours in the same venous
- sign of infection, hematoma, emphysema, in the area of cannulation
- history of cervical trauma
- severe hemostatic disorder (International Normalized Ratio>2, thrombocyte <50.000, Prothrombin time>1.5 times, Activated Partial Thromboplastin Time > 1.5 times
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Oblique Versus Transverse Transducer Orientation Approach for Ultrasound Guided Internal Jugular Venous Cannulation in Heart Surgery Pediatric Patients
this study aimed to compare oblique versus transverse orientation approach in jugular venous cannulation in term of cannulation success in pediatric heart surgery patients
Read the detailed description
Sixty patients randomised into two groups, 30 patients in experimental group (oblique orientation) and 30 patients in control group (transverse orientation). All cannulation took place in the operation room. Patients underwent general anesthesia and placed in supine position. Standard monitoring (electrocardiogram, non-invasive arterial pressure, pulseoxymetry) was carried out during the procedure for all patients. Before preparation of the skin, a pre-procedure ultrasound examination was performed to verify internal jugular vein patency, and its diameter was measured. Once the side had been chosen, the cannulation was performed following a sterile technique. All procedure were performed by Seldinger technique, with 22 Gauge IV catheter attached with 3 ml syringe as introducer needle. The vascular puncture was performed under ultrasound guidance, using a single-person technique. With transverse orientation, the transducer was placed transversally over the neck, and once the vein was visible in the middle of the ultrasound image, the needle was inserted in the plane perpendicular to the long axis of the transducer. With oblique orientation, the operator first obtained a transverse view of the vein and then rotated the transducer to 45 degrees (midway) between transverse and longitudinal view.
- Being tested
- internal jugular venous cannulation
- Keywords
- oblique orientation, transverse orientation, internal jugular venous cannulation, ultrasound guided, short axis, oblique axis
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
internal jugular venous cannulationProcedure or surgery
internal jugular venous cannulation
| Study group | Role | What they receive |
|---|---|---|
| Oblique orientation | Experimental | cannulation will be oblique approach Receives: Procedure: internal jugular venous cannulation |
| transverse approach | Active comparator | cannulation will be transverse approach Receives: Procedure: internal jugular venous cannulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
% of patients with successful cannulation in first attempt
The number of patients undergo cannulation with first attempt success are shown in percentage
Measured: at the procedure of cannulation
Secondary outcomes (1)
% of patients with successful cannulation with designed approach
The number of patients undergo cannulation using designed approach are shown in percentage
Measured: at the procedure of cannulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2022
- Study start1 Feb 2021
- Primary completion31 May 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart; Surgery, Heart, Functional Disturbance as ResultStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aldy Heriwardito, Universitas Indonesia
- Investigators
- aldy heriwardito, Doctor, Principal investigator, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05656937
- Sponsor's protocol ID
- IndonesiaUAnes109
- Status last verified
- Dec 2022
- First submitted
- 18 Jul 2021
- Last updated
- 19 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oblique Versus Transverse Transducer Orientation Approach for Ultrasound Guided Internal Jugular Venous Cannulation in Heart Surgery Pediatric Patients
- ClinicalTrials.gov ID
- NCT05656937
- Acronym / sponsor ID
- IndonesiaUAnes109
- Keywords
- oblique orientation, transverse orientation, internal jugular venous cannulation, ultrasound guided, short axis, oblique axis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 1 Feb 2021 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 19 Dec 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.
this study aimed to compare oblique versus transverse orientation approach in jugular venous cannulation in term of cannulation success in pediatric heart surgery patients
Detailed description
Sixty patients randomised into two groups, 30 patients in experimental group (oblique orientation) and 30 patients in control group (transverse orientation). All cannulation took place in the operation room. Patients underwent general anesthesia and placed in supine position. Standard monitoring (electrocardiogram, non-invasive arterial pressure, pulseoxymetry) was carried out during the procedure for all patients. Before preparation of the skin, a pre-procedure ultrasound examination was performed to verify internal jugular vein patency, and its diameter was measured. Once the side had been chosen, the cannulation was performed following a sterile technique. All procedure were performed by Seldinger technique, with 22 Gauge IV catheter attached with 3 ml syringe as introducer needle. The vascular puncture was performed under ultrasound guidance, using a single-person technique. With transverse orientation, the transducer was placed transversally over the neck, and once the vein was visible in the middle of the ultrasound image, the needle was inserted in the plane perpendicular to the long axis of the transducer. With oblique orientation, the operator first obtained a transverse view of the vein and then rotated the transducer to 45 degrees (midway) between transverse and longitudinal view.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oblique orientation | Experimental | Procedure: internal jugular venous cannulationcannulation will be oblique approach |
| transverse approach | Active comparator | Procedure: internal jugular venous cannulationcannulation will be transverse approach |
Who may qualify
- Ages
- 3 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- patients age 3 months to 12 years old, weight 5-20 kg, male or female
- who undergo heart surgery and indicated to have central venous cannulation
- American Society of Anesthesiologist Physical Class 1-3
- Family or representation of the patients agreed to participate in this study and sign informed consent
Key exclusion criteria (5 listed)
- history of surgery in the area of cannulation
- already placed central venous cannulation <72 hours in the same venous
- sign of infection, hematoma, emphysema, in the area of cannulation
- history of cervical trauma
- severe hemostatic disorder (International Normalized Ratio>2, thrombocyte <50.000, Prothrombin time>1.5 times, Activated Partial Thromboplastin Time > 1.5 times
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 |
|---|---|---|
| internal jugular venous cannulationinternal jugular venous cannulation | Procedure or surgery | Oblique orientation, transverse approach |
Primary outcome
% of patients with successful cannulation in first attempt
Time frame: at the procedure of cannulation
The number of patients undergo cannulation with first attempt success are shown in percentage
1 secondary outcome
% of patients with successful cannulation with designed approach
Time frame: at the procedure of 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 19 Dec 2022.
- Individual participant dataSharing planned: Undecided
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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.
aldy heriwardito, Doctor principal investigator
Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing internal jugular venous cannulation in people with Heart; Surgery, Heart, Functional Disturbance as Result and Pediatric ALL, run by Universitas Indonesia at 1 site in Indonesia.
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 4 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 19 Dec 2022. 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 Indonesia. 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?
% of patients with successful cannulation in first attempt (time frame: at the procedure of cannulation). 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 19 Dec 2022.