Internal Jugular Vein (IJV) Blood Flow in Gynecological Laparoscopic SurgeryNCT04922060
Evaluation of Cerebral Venous Return With Internal Jugular Vein Blood Flow in Gynecological Laparoscopic Surgery
An observational study of Internal Jugular Vein (IJV) Blood Flow in Gynecological Laparoscopic Surgery, run by Selcuk University.
Trial summary
The steep Trendelenburg position (STP) provides an advantage in laparoscopic procedures as it optimizes the surgical image. In laparoscopic operations, the need for CO2 pneumoperitoneum (PP), together with this non-physiological position, raises concerns about the patient's physiological homeostasis. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Internal Jugular Vein (IJV) Blood Flow in Gynecological Laparoscopic Surgery
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- 8 Jun 2021to 30 Jun 2021
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: ASA I-II physical status, age between 18 and 65 years, and planned gynecological laparoscopic surgery.
Who may be able to join
- ASA I-II physical status age between 18 and 65 years planned gynecological laparoscopic surgery. -
Who cannot join
- history of head and neck surgery history of cerebrovascular disease ASA III-IV physical status
- -
Trial locations and contacts
No sites are listed yet.
About this study
The steep Trendelenburg position (STP) provides an advantage in laparoscopic procedures as it optimizes the surgical image. In laparoscopic operations, the need for CO2 pneumoperitoneum (PP), together with this non-physiological position, raises concerns about the patient's physiological homeostasis. Although most patients seem to tolerate the combination of STP and PP, this method carries risks of ICP (intracranial pressure) and brain perfusion. The head-down position increases arterial pressure as well as CVP, thereby disrupting cerebral venous drainage and increasing hydrostatic pressures in the cerebral vascular system. This increases cerebrovascular resistance and decreases cerebral blood flow by increasing ICP and cerebral edema. Systemic CO2 absorption from pneumoperitoneum causes hypercarbia. Hypercarbia can increase cerebral blood flow through cerebral vasodilation.
Seventy-four percent to 95% of cerebral venous drainage in the supine position is provided by IJVs. Studies have shown that IJVs, which are responsible for most cerebral venous drainage, exhibit changes in diameter and blood flow due to TP. These studies were generally conducted on moderate TP and on healthy volunteers. In this study, we aim to evaluate the effects of a steep Trendelenburg position (25°) and pneumoperitoneum on IJV blood flow in patients undergoing operation under general anesthesia
- Keywords
- Laparoscopic surgery, cerebral venous drainage, internal jugular vein
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in internal jugular vein blood flow in laparoscopic gynecological cases
to evaluate the effects of the pneumoperitoneum (PP) and steep Trendelenburg position (STP) on cerebral venous return with internal jugular vein (IJV) blood flow in gynecological laparoscopic surgery
Measured: 90 minute
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2021
- Study start8 Jun 2021 (estimated)
- Primary completion24 Jun 2021 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Internal Jugular Vein (IJV) Blood Flow in Gynecological Laparoscopic SurgeryStudies of the same condition, open and under way.
- More trials run by Selcuk 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 only
- Time perspective
- Prospective
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Selcuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, EMİNE ASLANLAR, Selcuk University
- Investigators
- emine ASLANLAR, Principal investigator, selcuk univercity medical faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04922060
- Sponsor's protocol ID
- EASLANLAR
- Status last verified
- Jun 2021
- First submitted
- 4 Jun 2021
- Last updated
- 15 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kalmar AF, Foubert L, Hendrickx JF, Mottrie A, Absalom A, Mortier EP, Struys MM. Influence of steep Trendelenburg position and CO(2) pneumoperitoneum on cardiovascular, cerebrovascular, and respiratory homeostasis during robotic prostatectomy. Br J Anaesth. 2010 Apr;104(4):433-9. doi: 10.1093/bja/aeq018. Epub 2010 Feb 18.
PubMed 20167583Yeoh TY, Venkatraghavan L, Fisher JA, Meineri M. Internal jugular vein blood flow in the upright position during external compression and increased central venous pressure: an ultrasound study in healthy volunteers. Can J Anaesth. 2017 Aug;64(8):854-859. doi: 10.1007/s12630-017-0903-3. Epub 2017 Jun 2.
PubMed 28577164Uluer MS, Sargin M, Basaran B. Comparison of the effect of the right lateral tilt position and Trendelenburg position on the right internal jugular vein in healthy volunteers: A prospective observational study. J Vasc Access. 2019 Nov;20(6):672-676. doi: 10.1177/1129729819838169. Epub 2019 Apr 12.
PubMed 30977416Lee JG, Park HB, Shin HY, Kim JD, Yu SB, Kim DS, Ryu SJ, Kim GH. Effect of Trendelenburg position on right and left internal jugular vein cross-sectional area. Korean J Anesthesiol. 2014 Nov;67(5):305-9. doi: 10.4097/kjae.2014.67.5.305. Epub 2014 Nov 26.
PubMed 25473458Terai C, Anada H, Matsushima S, Shimizu S, Okada Y. Effects of mild Trendelenburg on central hemodynamics and internal jugular vein velocity, cross-sectional area, and flow. Am J Emerg Med. 1995 May;13(3):255-8. doi: 10.1016/0735-6757(95)90194-9.
PubMed 7755812Marcus HE, Bonkat E, Dagtekin O, Schier R, Petzke F, Wippermann J, Bottiger BW, Teschendorf P. The impact of Trendelenburg position and positive end-expiratory pressure on the internal jugular cross-sectional area. Anesth Analg. 2010 Aug;111(2):432-6. doi: 10.1213/ANE.0b013e3181e2fe41. Epub 2010 May 19.
PubMed 20484538Ishida S, Miyati T, Ohno N, Hiratsuka S, Alperin N, Mase M, Gabata T. MRI-based assessment of acute effect of head-down tilt position on intracranial hemodynamics and hydrodynamics. J Magn Reson Imaging. 2018 Feb;47(2):565-571. doi: 10.1002/jmri.25781. Epub 2017 Jun 3.
PubMed 28577333
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Cerebral Venous Return With Internal Jugular Vein Blood Flow in Gynecological Laparoscopic Surgery
- ClinicalTrials.gov ID
- NCT04922060
- Acronym / sponsor ID
- EASLANLAR
- Keywords
- Laparoscopic surgery, cerebral venous drainage, internal jugular vein
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Selcuk UniversityUniversity, hospital or other
- Study start
- 8 Jun 2021 (estimated)
- Primary completion
- 24 Jun 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 10 Jun 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 steep Trendelenburg position (STP) provides an advantage in laparoscopic procedures as it optimizes the surgical image. In laparoscopic operations, the need for CO2 pneumoperitoneum (PP), together with this non-physiological position, raises concerns about the patient's physiological homeostasis. Although most patients seem to tolerate the combination of STP and PP, this method carries risks of ICP (intracranial pressure) and brain perfusion. The head-down position increases arterial pressure as well as CVP, thereby disrupting cerebral venous drainage and increasing hydrostatic pressures in the cerebral vascular system. This increases cerebrovascular resistance and decreases cerebral blood flow by increasing ICP and cerebral edema. Systemic CO2 absorption from pneumoperitoneum causes hypercarbia. Hypercarbia can increase cerebral blood flow through cerebral vasodilation.
Seventy-four percent to 95% of cerebral venous drainage in the supine position is provided by IJVs. Studies have shown that IJVs, which are responsible for most cerebral venous drainage, exhibit changes in diameter and blood flow due to TP. These studies were generally conducted on moderate TP and on healthy volunteers. In this study, we aim to evaluate the effects of a steep Trendelenburg position (25°) and pneumoperitoneum on IJV blood flow in patients undergoing operation under general anesthesia
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- ASA I-II physical status, age between 18 and 65 years, and planned gynecological laparoscopic surgery.
Key inclusion criteria (1 listed)
- ASA I-II physical status age between 18 and 65 years planned gynecological laparoscopic surgery. -
Key exclusion criteria (2 listed)
- history of head and neck surgery history of cerebrovascular disease ASA III-IV physical status
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in internal jugular vein blood flow in laparoscopic gynecological cases
Time frame: 90 minute
to evaluate the effects of the pneumoperitoneum (PP) and steep Trendelenburg position (STP) on cerebral venous return with internal jugular vein (IJV) blood flow in gynecological laparoscopic surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2021.
- Results publication: PubMed 20167583Kalmar AF, Foubert L, Hendrickx JF, Mottrie A, Absalom A, Mortier EP, Struys MM. Influence of steep Trendelenburg position and CO(2) pneumoperitoneum on cardiovascular, cerebrovascular, and respiratory homeostasis during robotic prostatectomy. Br J Anaesth. 2010 Apr;104(4):433-9. doi: 10.1093/bja/aeq018. Epub 2010 Feb 18.
- Results publication: PubMed 28577164Yeoh TY, Venkatraghavan L, Fisher JA, Meineri M. Internal jugular vein blood flow in the upright position during external compression and increased central venous pressure: an ultrasound study in healthy volunteers. Can J Anaesth. 2017 Aug;64(8):854-859. doi: 10.1007/s12630-017-0903-3. Epub 2017 Jun 2.
- Results publication: PubMed 30977416Uluer MS, Sargin M, Basaran B. Comparison of the effect of the right lateral tilt position and Trendelenburg position on the right internal jugular vein in healthy volunteers: A prospective observational study. J Vasc Access. 2019 Nov;20(6):672-676. doi: 10.1177/1129729819838169. Epub 2019 Apr 12.
- Results publication: PubMed 25473458Lee JG, Park HB, Shin HY, Kim JD, Yu SB, Kim DS, Ryu SJ, Kim GH. Effect of Trendelenburg position on right and left internal jugular vein cross-sectional area. Korean J Anesthesiol. 2014 Nov;67(5):305-9. doi: 10.4097/kjae.2014.67.5.305. Epub 2014 Nov 26.
- Results publication: PubMed 7755812Terai C, Anada H, Matsushima S, Shimizu S, Okada Y. Effects of mild Trendelenburg on central hemodynamics and internal jugular vein velocity, cross-sectional area, and flow. Am J Emerg Med. 1995 May;13(3):255-8. doi: 10.1016/0735-6757(95)90194-9.
- Results publication: PubMed 20484538Marcus HE, Bonkat E, Dagtekin O, Schier R, Petzke F, Wippermann J, Bottiger BW, Teschendorf P. The impact of Trendelenburg position and positive end-expiratory pressure on the internal jugular cross-sectional area. Anesth Analg. 2010 Aug;111(2):432-6. doi: 10.1213/ANE.0b013e3181e2fe41. Epub 2010 May 19.
- Results publication: PubMed 28577333Ishida S, Miyati T, Ohno N, Hiratsuka S, Alperin N, Mase M, Gabata T. MRI-based assessment of acute effect of head-down tilt position on intracranial hemodynamics and hydrodynamics. J Magn Reson Imaging. 2018 Feb;47(2):565-571. doi: 10.1002/jmri.25781. Epub 2017 Jun 3.
- Individual participant dataSharing planned: No
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.
emine ASLANLAR principal investigator
selcuk univercity medical faculty
Questions about this trial
What is this clinical trial studying?
An observational study of Internal Jugular Vein (IJV) Blood Flow in Gynecological Laparoscopic Surgery, run by Selcuk University.
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 2 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: status not confirmed, as of the sponsor's last update on 15 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact emine ASLANLAR (05556219830, draslanlar@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in internal jugular vein blood flow in laparoscopic gynecological cases (time frame: 90 minute). 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 NCT04922060, which also lists 7 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 15 Jun 2021.