NCT04233177

Brief Summary

The investigators will evaluate the change of the common carotid artery blood flow according to patient's position and penumoperitoneum.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 9, 2020

Completed
4 days until next milestone

Study Start

First participant enrolled

January 13, 2020

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 18, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 23, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 23, 2021

Completed
Last Updated

January 19, 2022

Status Verified

January 1, 2022

Enrollment Period

1.1 years

First QC Date

January 9, 2020

Last Update Submit

January 17, 2022

Conditions

PerfusionPerioperative/Postoperative Complications

Keywords

Common carotid arteryTrendelenburgPneumoperitoneumBlood flow

Outcome Measures

Primary Outcomes (1)

  • Change of the common carotid artery blood flow velocity

    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 Outcomes (5)

  • Change of the common carotid artery beat volume

    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

    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

    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

    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

    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

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients undergoing gynecology surgery under trendelenburg position

You may qualify if:

  • ASA class I,II
  • patients undergoing gynecology surgery under trendelenburg position
  • Age ranges from 20 to 70

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jin-Tae Kim

Seoul, South Korea

Location

Related Publications (1)

  • 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.

    PMID: 36463542DERIVED

MeSH Terms

Conditions

Postoperative ComplicationsPneumoperitoneum

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsPeritoneal DiseasesDigestive System Diseases

Study Officials

  • Jin-Tae Kim, PhD

    Seoul National University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

January 9, 2020

First Posted

January 18, 2020

Study Start

January 13, 2020

Primary Completion

February 23, 2021

Study Completion

February 23, 2021

Last Updated

January 19, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)