- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04233177
The Effect of Trendelenburg Position on CCA Blood Flow
January 17, 2022 updated by: Jin-Tae Kim, Seoul National University Hospital
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.
Study Overview
Status
Completed
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 Type
Observational
Enrollment (Actual)
20
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Seoul, Korea, Republic of
- Jin-Tae Kim
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
patients undergoing gynecology surgery under trendelenburg position
Description
Inclusion Criteria:
- ASA class I,II
- patients undergoing gynecology surgery under trendelenburg position
- Age ranges from 20 to 70
Exclusion Criteria:
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
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 Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
Common carotid artery beat volume was calculated from median common carotid artery beat velocity and vessel diameter
|
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
|
Common carotid artery diameter is obtained using US
|
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
|
Mean arterial pressure is obtained concurrently with common carotid artery blood flow velocity measurements
|
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
|
Cardiac output was obtained using FloTrac(EdwardLifescience, USA)
|
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
|
Peak inspiratory airway pressure is obtained using the ventilator system
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 13, 2020
Primary Completion (Actual)
February 23, 2021
Study Completion (Actual)
February 23, 2021
Study Registration Dates
First Submitted
January 9, 2020
First Submitted That Met QC Criteria
January 15, 2020
First Posted (Actual)
January 18, 2020
Study Record Updates
Last Update Posted (Actual)
January 19, 2022
Last Update Submitted That Met QC Criteria
January 17, 2022
Last Verified
January 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CCA-BF
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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