Ability of Cardio Q for Prediction of Hypotension

December 18, 2020 updated by: So Yeon Kim, Severance Hospital

Ability of Cardio Q for Prediction of Hypotension After Postural Change in Robot-Assisted Laparoscopic Radical Prostatectomy

Evaluation the ability of each indicator of Cardio Q in predicting hypotension after position changes in robot-assisted laparoscopic radical prostatectomy

Study Overview

Status

Completed

Conditions

Detailed Description

Hypotension is common in patients who undergo general anesthesia. Hypotension may cause hypoperfusion in the organs of the body, resulting in ischemia and increased mortality within one year. Hypotension may occur at any time during general anesthesia but may also occur with changes in posture. In robot-assisted laparoscopic radical prostatectomy, hypotension often occurs when posture is changed from a Trendelenburg position to a supine position. However there is no data regarding which hemodynamic parameters can predict hypotension induced by position change.

Excessive administration of the fluid in steep Trendelenburg position may lead to fluid overload and lead to complications such as pulmonary edema. Thus, the predictors are should be identified to manage patients without fluid overload. Therefore, the aim of this study is to investigate the parameters of Cardio Q which are useful for predicting hypotension after position change.

Study Type

Observational

Enrollment (Actual)

125

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

  • Korea, Republic of
      • Seoul, Korea, Republic of
        • Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine
      • Seoul, Korea, Republic of
        • Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Severance Hospital, Yonsei University College of Medicine

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 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

ASA 1-3 Patient undergoing robot-assisted laparoscopic radical prostatectomy

Description

Inclusion Criteria:

Patients undergoing robot-assisted laparoscopic radical prostatectomy ASA 1-3

Exclusion Criteria:

Patients that

  • Unstable angina, left ventricular ejection fraction <40%
  • Severe vascular disease
  • Insertion type : pacemaker / defibrillator
  • Autonomic nervous system diseases
  • When esophageal varices are present
  • If the subject includes a person who can not read the written consent (eg, illiterate, foreigner, etc.)

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
Mean arterial pressure
Time Frame: Before position change, After position change (1, 3, 5, 7, and 10 minutes)
The changes mean arterial pressure
Before position change, After position change (1, 3, 5, 7, and 10 minutes)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Severance Hospital

Investigators

  • Principal Investigator: So Yeon Kim, MD, PhD, Severance Hospital, Yonsei University College of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 1, 2019

Primary Completion (Actual)

September 24, 2020

Study Completion (Actual)

September 24, 2020

Study Registration Dates

First Submitted

February 12, 2019

First Submitted That Met QC Criteria

March 19, 2019

First Posted (Actual)

March 20, 2019

Study Record Updates

Last Update Posted (Actual)

December 21, 2020

Last Update Submitted That Met QC Criteria

December 18, 2020

Last Verified

December 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4-2018-0976

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.

Clinical Trials on Prostate Cancer

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Singapore

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe