Central Line ComplicationUSG-IJVNCT01790334
Effects of Different Modes of Ventilation and Head Position on Size of Vena Jugular Interna
An observational study of Central Line Complication, run by Istanbul University at 1 site in Turkey (Türkiye).
Trial summary
It is widely known that positive mechanical ventilation increases the positive intrathoracic pressure which affects the pressure in the RIJV, resulting in an increase of the CSA. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Central Line Complication
- What is being tested?
- Ultrasonography
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Feb 2013to Mar 2013
- How long will I take part?
- 1 Day
- 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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: 30 ASA status I-II patients between 18-80 years old undergoing elective abdominal surgery under endotracheal intubation will be included in this random, prospective, clinical study.
Who may be able to join
- 30 ASA status I-II patients between 18-80 years old undergoing elective abdominal surgery
Who cannot join
- Patients with a history of congestive heart failure, pulmonary hypertension, chronic renal failure, diabetes mellitus, rheumatological diseases, neck surgery, valvular disease, obesity or RIJV catheterization will be excluded from the study
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Cerrahpasa Medical Faculty Anesthesiology and Reanimation Department
Istanbul, Fatih, 34400
About this study
Official title: Comparing the Size of the Vena Jugular Interna Under Spontaneous Ventilation and Different Mechanical Ventilation Modes When Head is in Neutral and 30 Degree Lateral Position:Clinical Trial
It is widely known that positive mechanical ventilation increases the positive intrathoracic pressure which affects the pressure in the RIJV, resulting in an increase of the CSA. Currently, there appears to be a lack of studies in the literature that assess the effects of different modes of ventilation of this increase.
The aim of our study is to evaluate the changes in cross-sectional area and diameters of RIJV under two different mechanical ventilation modes (PCV and VCV) and spontaneous ventilation in head neutral and 30 degree rotated lateral position by using ultrasonography and to determine the ventilation mode that is most suitable for catheterization.
- Conditions
- Central Line Complication
- Being tested
- Ultrasonography
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasonographyOther
Also called The crosssectional area and diameter of right internal jugular vein will be measured by ultrasonography
| Study group | Role | What they receive |
|---|---|---|
| Spontenous Ventilation (Group S) | ultrasonography of Right internal jugular vein Receives: Other: Ultrasonography | |
| Pressure control Ventilation (Group P) | ultrasonography of Right internal jugular vein Receives: Other: Ultrasonography | |
| Volume control ventilation (Group V) | ultrasonography of Right internal jugular vein Receives: Other: Ultrasonography |
What is being measured
The primary outcome is the main question the study is designed to answer.
comparing the size of right internal jugular vein in different mechanical ventilation modes
Measured: 1 month
Secondary outcomes (1)
effect of different head positions on the right internal jugular vein size
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2013 (estimated)
- Study startFeb 2013
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Central Line ComplicationStudies of the same condition, open and under way.
- More trials run by Istanbul UniversityThe 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 crossover
- Time perspective
- Prospective
- Enrolment
- 30 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Istanbul University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Guniz M.Koksal, Istanbul University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01790334
- Sponsor's protocol ID
- 32488
- Acronym
- USG-IJV
- Status last verified
- Feb 2013
- First submitted
- 11 Feb 2013
- Last updated
- 29 Aug 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Lobato EB, Florete OG Jr, Paige GB, Morey TE. Cross-sectional area and intravascular pressure of the right internal jugular vein during anesthesia: effects of Trendelenburg position, positive intrathoracic pressure, and hepatic compression. J Clin Anesth. 1998 Feb;10(1):1-5. doi: 10.1016/s0952-8180(97)00189-x.
PubMed 9526929
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Size of the Vena Jugular Interna Under Spontaneous Ventilation and Different Mechanical Ventilation Modes When Head is in Neutral and 30 Degree Lateral Position:Clinical Trial
- ClinicalTrials.gov ID
- NCT01790334
- Acronym / sponsor ID
- USG-IJV / 32488
- Conditions
- Central Line Complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Istanbul UniversityUniversity, hospital or other
- Study start
- Feb 2013
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 13 Feb 2013 (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.
It is widely known that positive mechanical ventilation increases the positive intrathoracic pressure which affects the pressure in the RIJV, resulting in an increase of the CSA. Currently, there appears to be a lack of studies in the literature that assess the effects of different modes of ventilation of this increase.
The aim of our study is to evaluate the changes in cross-sectional area and diameters of RIJV under two different mechanical ventilation modes (PCV and VCV) and spontaneous ventilation in head neutral and 30 degree rotated lateral position by using ultrasonography and to determine the ventilation mode that is most suitable for catheterization.
Study design
- Observational model
- Case crossover
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Spontenous Ventilation (Group S) | – | Other: Ultrasonographyultrasonography of Right internal jugular vein |
| Pressure control Ventilation (Group P) | – | Other: Ultrasonographyultrasonography of Right internal jugular vein |
| Volume control ventilation (Group V) | – | Other: Ultrasonographyultrasonography of Right internal jugular vein |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 30 ASA status I-II patients between 18-80 years old undergoing elective abdominal surgery under endotracheal intubation will be included in this random, prospective, clinical study.
Key inclusion criteria (1 listed)
- 30 ASA status I-II patients between 18-80 years old undergoing elective abdominal surgery
Key exclusion criteria (1 listed)
- Patients with a history of congestive heart failure, pulmonary hypertension, chronic renal failure, diabetes mellitus, rheumatological diseases, neck surgery, valvular disease, obesity or RIJV catheterization will be excluded from the study
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 |
|---|---|---|
| UltrasonographyAlso: The crosssectional area and diameter of right internal jugular vein will be measured by ultrasonography | Other | Pressure control Ventilation (Group P), Spontenous Ventilation (Group S), Volume control ventilation (Group V) |
Primary outcome
comparing the size of right internal jugular vein in different mechanical ventilation modes
Time frame: 1 month
1 secondary outcome
effect of different head positions on the right internal jugular vein size
Time frame: 1 month
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 29 Aug 2013.
- Results publication: PubMed 9526929Lobato EB, Florete OG Jr, Paige GB, Morey TE. Cross-sectional area and intravascular pressure of the right internal jugular vein during anesthesia: effects of Trendelenburg position, positive intrathoracic pressure, and hepatic compression. J Clin Anesth. 1998 Feb;10(1):1-5. doi: 10.1016/s0952-8180(97)00189-x.
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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.
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?
An observational study of Central Line Complication, run by Istanbul University at 1 site in Turkey (Türkiye).
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 1 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 29 Aug 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 Turkey (Türkiye). 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?
comparing the size of right internal jugular vein in different mechanical ventilation modes (time frame: 1 month). 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 NCT01790334, which also lists 1 linked publication.
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 29 Aug 2013.