PerfusionNCT04233177
The Effect of Trendelenburg Position on CCA Blood Flow
An observational study of Perfusion and Perioperative/Postoperative Complications, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The investigators will evaluate the change of the common carotid artery blood flow according to patient's position and penumoperitoneum. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Perfusion, Perioperative/Postoperative Complications
- How many people
- 20 participants
- Where
- 1 siteSouth Korea
- Study dates
- 13 Jan 2020to 23 Feb 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 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: patients undergoing gynecology surgery under trendelenburg position
Who may be able to join
- ASA class I,II
- patients undergoing gynecology surgery under trendelenburg position
- Age ranges from 20 to 70
Who cannot join
- BMI > 32
- Pregnancy
- Patients who did not agree to study
- Patients with allergies to the drugs used in this study
- Patients with anatomical variations or lesions in cervical or cranial vascular portion
- Patients with arrhythmia that may alter patient's cardiac output(e.g. artrial fibrillation)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Influence of Anesthesia, Pneumoperitoneum, and Patient Position on Common Carotid Artery Blood Flow During Laparoscopic Gynecology Operation
The investigators will evaluate the change of the common carotid artery blood flow according to patient's position and penumoperitoneum.
Read the detailed description
The study will include 20 patients undergoing gynecological surgery. The common carotid artery blood flow will be measured using Doppler US during the following conditions; supine position before induction of anesthesia, supine position immediately after induction of anesthesia, supine position with penumoperitoneum, head-down position with or without pneumoperitoneum.
- Keywords
- Common carotid artery, Trendelenburg, Pneumoperitoneum, Blood flow
- Medical subject headings
- Postoperative Complications, Pneumoperitoneum
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of the common carotid artery blood flow velocity
Common carotid artery blood flow velocity is measured using Doppler US
Measured: 1) baseline, 2) Immediately after induction of anesthesia, 3) immediately after pneumoperitoneum, 4) immediately after Trendelenburg position with penumoperitoneum, 5) Immediately after desufflation in Trendelenburg position
Secondary outcomes (5)
Change of the common carotid artery beat volume
Common carotid artery beat volume was calculated from median common carotid artery beat velocity and vessel diameter
Measured: 1) baseline, 2) Immediately after induction of anesthesia, 3) immediately after pneumoperitoneum, 4) immediately after Trendelenburg position with penumoperitoneum, 5) Immediately after desufflation in Trendelenburg position
Change of the common carotid artery diameter
Common carotid artery diameter is obtained using US
Measured: 1) baseline, 2) Immediately after induction of anesthesia, 3) immediately after pneumoperitoneum, 4) immediately after Trendelenburg position with penumoperitoneum, 5) Immediately after desufflation in Trendelenburg position
Change of mean arterial blood pressure
Mean arterial pressure is obtained concurrently with common carotid artery blood flow velocity measurements
Measured: 1) baseline, 2) Immediately after induction of anesthesia, 3) immediately after pneumoperitoneum, 4) immediately after Trendelenburg position with penumoperitoneum, 5) Immediately after desufflation in Trendelenburg position
Change of cardiac output
Cardiac output was obtained using FloTrac(EdwardLifescience, USA)
Measured: 1) baseline, 2) Immediately after induction of anesthesia, 3) immediately after pneumoperitoneum, 4) immediately after Trendelenburg position with penumoperitoneum, 5) Immediately after desufflation in Trendelenburg position
Change of peak inspiration airway pressure
Peak inspiratory airway pressure is obtained using the ventilator system
Measured: 1) baseline, 2) Immediately after induction of anesthesia, 3) immediately after pneumoperitoneum, 4) immediately after Trendelenburg position with penumoperitoneum, 5) Immediately after desufflation in Trendelenburg position
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2020
- Study start13 Jan 2020
- Primary completion23 Feb 2021
- Study completion23 Feb 2021
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 PerfusionStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jin-Tae Kim, Seoul National University Hospital
- Investigators
- Jin-Tae Kim, PhD, Principal investigator, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04233177
- Sponsor's protocol ID
- CCA-BF
- Status last verified
- Jan 2022
- First submitted
- 9 Jan 2020
- Last updated
- 19 Jan 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Yoon HK, Bae H, Yoo S, Kim YW, Bae J, Park SK, Kim H, Lim YJ, Kim JT. Relationships between common carotid artery blood flow and anesthesia, pneumoperitoneum, and head-down tilt position: a linear mixed-effect analysis. J Clin Monit Comput. 2023 Apr;37(2):669-677. doi: 10.1007/s10877-022-00940-z. Epub 2022 Dec 4.
PubMed 36463542
Study at a glance
From the registry record, last updated by the sponsor on 19 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Anesthesia, Pneumoperitoneum, and Patient Position on Common Carotid Artery Blood Flow During Laparoscopic Gynecology Operation
- ClinicalTrials.gov ID
- NCT04233177
- Acronym / sponsor ID
- CCA-BF
- Keywords
- Common carotid artery, Trendelenburg, Pneumoperitoneum, Blood flow
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- 13 Jan 2020 (actual)
- Primary completion
- 23 Feb 2021 (actual)
- Study completion
- 23 Feb 2021 (actual)
- First posted
- 18 Jan 2020 (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 investigators will evaluate the change of the common carotid artery blood flow according to patient's position and penumoperitoneum.
Detailed description
The study will include 20 patients undergoing gynecological surgery. The common carotid artery blood flow will be measured using Doppler US during the following conditions; supine position before induction of anesthesia, supine position immediately after induction of anesthesia, supine position with penumoperitoneum, head-down position with or without pneumoperitoneum.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- patients undergoing gynecology surgery under trendelenburg position
Key inclusion criteria (3 listed)
- ASA class I,II
- patients undergoing gynecology surgery under trendelenburg position
- Age ranges from 20 to 70
Key exclusion criteria (6 listed)
- BMI > 32
- Pregnancy
- Patients who did not agree to study
- Patients with allergies to the drugs used in this study
- Patients with anatomical variations or lesions in cervical or cranial vascular portion
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 of the common carotid artery blood flow velocity
Time frame: 1) baseline, 2) Immediately after induction of anesthesia, 3) immediately after pneumoperitoneum, 4) immediately after Trendelenburg position with penumoperitoneum, 5) Immediately after desufflation in Trendelenburg position
Common carotid artery blood flow velocity is measured using Doppler US
5 secondary outcomes
Change of the common carotid artery beat volume
Time frame: 1) baseline, 2) Immediately after induction of anesthesia, 3) immediately after pneumoperitoneum, 4) immediately after Trendelenburg position with penumoperitoneum, 5) Immediately after desufflation in Trendelenburg position
Change of the common carotid artery diameter
Time frame: 1) baseline, 2) Immediately after induction of anesthesia, 3) immediately after pneumoperitoneum, 4) immediately after Trendelenburg position with penumoperitoneum, 5) Immediately after desufflation in Trendelenburg position
Change of mean arterial blood pressure
Time frame: 1) baseline, 2) Immediately after induction of anesthesia, 3) immediately after pneumoperitoneum, 4) immediately after Trendelenburg position with penumoperitoneum, 5) Immediately after desufflation in Trendelenburg position
Change of cardiac output
Time frame: 1) baseline, 2) Immediately after induction of anesthesia, 3) immediately after pneumoperitoneum, 4) immediately after Trendelenburg position with penumoperitoneum, 5) Immediately after desufflation in Trendelenburg position
Change of peak inspiration airway pressure
Time frame: 1) baseline, 2) Immediately after induction of anesthesia, 3) immediately after pneumoperitoneum, 4) immediately after Trendelenburg position with penumoperitoneum, 5) Immediately after desufflation in Trendelenburg position
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 Jan 2022.
- Derived from this study: PubMed 36463542Yoon HK, Bae H, Yoo S, Kim YW, Bae J, Park SK, Kim H, Lim YJ, Kim JT. Relationships between common carotid artery blood flow and anesthesia, pneumoperitoneum, and head-down tilt position: a linear mixed-effect analysis. J Clin Monit Comput. 2023 Apr;37(2):669-677. doi: 10.1007/s10877-022-00940-z. Epub 2022 Dec 4.
- Individual participant dataSharing planned: No
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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.
Jin-Tae Kim, PhD principal investigator
Seoul National University Hospital
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 Perfusion and Perioperative/Postoperative Complications, run by Seoul National University Hospital 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 3 inclusion and 6 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 Jan 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 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?
Change of the common carotid artery blood flow velocity (time frame: 1) baseline, 2) Immediately after induction of anesthesia, 3) immediately after pneumoperitoneum, 4) immediately after Trendelenburg position with penumoperitoneum, 5) Immediately after desufflation in Trendelenburg position). 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 NCT04233177, 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 19 Jan 2022.