Infants or Children Undergoing Open Heart SurgeryNCT01401920
The Influence of Passive Leg Elevation on the Cross-sectional Area of the Internal Jugular Vein in Infants or Young Children Undergoing Open Heart Surgery
An observational study of Infants or Children Undergoing Open Heart Surgery, run by Samsung Medical Center at 1 site in South Korea.
Trial summary
The trendelenburg position is usually applied to increase the cross-sectional area of the IJV. However, trendelenburg position requires a tilt table to place the head in the down position. Trendelenburg position could also increase intracranial pressure. Read more about this study
- Who is it for?
- Ages Up to 5 years
- Conditions the study is for
- Infants or Children Undergoing Open Heart Surgery
- What is being tested?
- leg elevation, Trendelenburg position and Trendelenburg position + passive leg elevation
- How many people
- 90 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jul 2011to Dec 2011
- Phase
- Observational
- 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 Up to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: infants or children undergoing open heart surgery for congenital anomaly for study period
Who may be able to join
- infants or children under 5 yrs undergoing elective open heart surgery for congenital anomaly for study period
Who cannot join
- previous history of internal jugular vein cannulation
- concurrent pulmonary disease that can influence the hemodynamics of right heart
- increased intracranial pressure
- hemodynamic unstability
Trial locations and contacts
1 site in 1 country.
About this study
The trendelenburg position is usually applied to increase the cross-sectional area of the IJV. However, trendelenburg position requires a tilt table to place the head in the down position. Trendelenburg position could also increase intracranial pressure. Passive leg elevation redistributes more blood from the lower extremity into the central veins and is proved to increase the cross-sectional area of IJV in adults. However, the effect of leg elevation on the cross-sectional area of IJV in small infants and children has not been evaluated.
The investigators evaluated the effect of passive leg elevation on the cross-sectional area of IJV in subjects undergoing open heart surgery for congenital anomaly.
Read the detailed description
Internal jugular vein (IJV) cannulation is essential for open heart surgery of small infants and children for transfusion or inotropics infusion. The trendelenburg position is usually applied to increase the cross-sectional area of the IJV.
However, trendelenburg position requires a tilt table to place the head in the down position. Trendelenburg position could also increase intracranial pressure. Passive leg elevation redistributes more blood from the lower extremity into the central veins and is proved to increase the cross-sectional area of IJV in adults. However, the effect of leg elevation on the cross-sectional area of IJV in small infants and children has not been evaluated. Furthermore, the children undergoing open heart surgery due to cardiac anomaly have an altered hemodynamics and often congested right heart. Therefore, the response of passive leg elevation may be different from that of normal heart physiology. Therefore, we evaluated the effect of passive leg elevation on the cross-sectional area of IJV in subjects undergoing open heart surgery for congenital anomaly.
- Being tested
- leg elevation, Trendelenburg position, Trendelenburg position + passive leg elevation, control group
- Keywords
- internal jugular vein cannulation, cross-sectional area, passive leg elevation, trendelenburg position, open heart surgery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
leg elevationOther
bilateral passive leg elevation for 30 seconds
Trendelenburg positionOther
Trendelenburg position (15 degrees) for 30 seconds
Trendelenburg position + passive leg elevationOther
Trendelenburg position + passive leg elevation
control groupOther
supine position without passive leg elevation or trendelenburg position
| Study group | Role | What they receive |
|---|---|---|
| patients undergoing open heart surgery | small infant or children patients undergoing open heart surgery Receives: Other: leg elevation; Other: Trendelenburg position; Other: Trendelenburg position + passive leg elevation; Other: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cross-sectional area of internal jugular vein
Cross-sectional area of internal jugular vein measured on the ultrasonographic image with planimetry method
Measured: one time measurement 10 min before jugular vein cannulation
Secondary outcomes (3)
Transverse diameter of internal jugular vein
Transverse diameter of internal jugular vein measured on the ultrasonographic image
Measured: only one time measurements 10 min before internal jugular vein cannulation
horizontal diameter of internal jugular vein
horizontal diameter of internal jugular vein measured on the ultrasonographic image
Measured: only one time measurements 10 min before jugular vein cannulation
skin to internal jugular vein depth
skin to internal jugular vein depth measured on the ultrasonographic image
Measured: one time measurement 10 min before jugular vein cannulation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2011 (estimated)
- Study startJul 2011
- Primary completionDec 2011
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infants or Children Undergoing Open Heart SurgeryStudies of the same condition, open and under way.
- More trials run by Samsung Medical CenterThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsung Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chung Su Kim, Samsung Medical Center
- Investigators
- Chung Su Kim, M.D.,Ph.D., Principal investigator, Samsung Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01401920
- Sponsor's protocol ID
- 2011-05-093
- Status last verified
- Dec 2013
- First submitted
- 22 Jul 2011
- Last updated
- 25 Dec 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Influence of Passive Leg Elevation on the Cross-sectional Area of the Internal Jugular Vein in Infants or Young Children Undergoing Open Heart Surgery
- ClinicalTrials.gov ID
- NCT01401920
- Acronym / sponsor ID
- 2011-05-093
- Keywords
- internal jugular vein cannulation, cross-sectional area, passive leg elevation, trendelenburg position, open heart surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Samsung Medical CenterUniversity, hospital or other
- Study start
- Jul 2011
- Primary completion
- Dec 2011 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 25 Jul 2011 (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.
The trendelenburg position is usually applied to increase the cross-sectional area of the IJV. However, trendelenburg position requires a tilt table to place the head in the down position. Trendelenburg position could also increase intracranial pressure. Passive leg elevation redistributes more blood from the lower extremity into the central veins and is proved to increase the cross-sectional area of IJV in adults. However, the effect of leg elevation on the cross-sectional area of IJV in small infants and children has not been evaluated.
The investigators evaluated the effect of passive leg elevation on the cross-sectional area of IJV in subjects undergoing open heart surgery for congenital anomaly.
Detailed description
Internal jugular vein (IJV) cannulation is essential for open heart surgery of small infants and children for transfusion or inotropics infusion. The trendelenburg position is usually applied to increase the cross-sectional area of the IJV.
However, trendelenburg position requires a tilt table to place the head in the down position. Trendelenburg position could also increase intracranial pressure. Passive leg elevation redistributes more blood from the lower extremity into the central veins and is proved to increase the cross-sectional area of IJV in adults. However, the effect of leg elevation on the cross-sectional area of IJV in small infants and children has not been evaluated. Furthermore, the children undergoing open heart surgery due to cardiac anomaly have an altered hemodynamics and often congested right heart. Therefore, the response of passive leg elevation may be different from that of normal heart physiology. Therefore, we evaluated the effect of passive leg elevation on the cross-sectional area of IJV in subjects undergoing open heart surgery for congenital anomaly.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients undergoing open heart surgery | – | Other: leg elevation, Other: Trendelenburg position, Other: Trendelenburg position + passive leg elevation, Other: control groupsmall infant or children patients undergoing open heart surgery |
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- infants or children undergoing open heart surgery for congenital anomaly for study period
Key inclusion criteria (1 listed)
- infants or children under 5 yrs undergoing elective open heart surgery for congenital anomaly for study period
Key exclusion criteria (4 listed)
- previous history of internal jugular vein cannulation
- concurrent pulmonary disease that can influence the hemodynamics of right heart
- increased intracranial pressure
- hemodynamic unstability
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 |
|---|---|---|
| leg elevationbilateral passive leg elevation for 30 seconds | Other | patients undergoing open heart surgery |
| Trendelenburg positionTrendelenburg position (15 degrees) for 30 seconds | Other | patients undergoing open heart surgery |
| Trendelenburg position + passive leg elevationTrendelenburg position + passive leg elevation | Other | patients undergoing open heart surgery |
| control groupsupine position without passive leg elevation or trendelenburg position | Other | patients undergoing open heart surgery |
Primary outcome
Cross-sectional area of internal jugular vein
Time frame: one time measurement 10 min before jugular vein cannulation
Cross-sectional area of internal jugular vein measured on the ultrasonographic image with planimetry method
3 secondary outcomes
Transverse diameter of internal jugular vein
Time frame: only one time measurements 10 min before internal jugular vein cannulation
horizontal diameter of internal jugular vein
Time frame: only one time measurements 10 min before jugular vein cannulation
skin to internal jugular vein depth
Time frame: one time measurement 10 min before jugular vein 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 25 Dec 2013.
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.
Chung Su Kim, M.D.,Ph.D. principal investigator
Samsung Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infants or Children Undergoing Open Heart Surgery, run by Samsung Medical Center at 1 site in South Korea.
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 25 Dec 2013. 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 South Korea. 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?
Cross-sectional area of internal jugular vein (time frame: one time measurement 10 min before jugular vein 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 25 Dec 2013.