Ability of Cardio Q for Prediction of Hypotension

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ClinicalTrials.gov Identifier: NCT03882697

Recruitment Status : Completed

First Posted : March 20, 2019

Last Update Posted : December 21, 2020

Sponsor:

Information provided by (Responsible Party):

So Yeon Kim, Severance Hospital

Study Description

Brief Summary:

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

Condition or disease
Prostate Cancer

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 Design

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Study Type :	Observational
Actual Enrollment :	125 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	Ability of Cardio Q for Prediction of Hypotension After Postural Change in Robot-Assisted Laparoscopic Radical Prostatectomy
Actual Study Start Date :	January 1, 2019
Actual Primary Completion Date :	September 24, 2020
Actual Study Completion Date :	September 24, 2020

Resource links provided by the National Library of Medicine

MedlinePlus Genetics related topics: Prostate cancer

MedlinePlus related topics: Low Blood Pressure

U.S. FDA Resources

Groups and Cohorts

Outcome Measures

Primary Outcome Measures :

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

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	20 Years to 85 Years (Adult, Older Adult)
Sexes Eligible for Study:	Male
Gender Based Eligibility:	Yes
Gender Eligibility Description:	Only male can have prostate
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

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

Criteria

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.)

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03882697

Locations

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

Sponsors and Collaborators

Severance Hospital

Investigators

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

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Kim NY, Kim KJ, Kim TL, Shin HJ, Oh C, Lee MH, Min JY, Kim SY. Prediction of hypotension after postural change in robot-assisted laparoscopic prostatectomy using esophageal Doppler monitoring: a prospective observational trial. Sci Rep. 2021 Jul 16;11(1):14589. doi: 10.1038/s41598-021-93990-3.

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Responsible Party:	So Yeon Kim, Associate professor, Severance Hospital
ClinicalTrials.gov Identifier:	NCT03882697
Other Study ID Numbers:	4-2018-0976
First Posted:	March 20, 2019 Key Record Dates
Last Update Posted:	December 21, 2020
Last Verified:	December 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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Studies a U.S. FDA-regulated Drug Product:	No
Studies a U.S. FDA-regulated Device Product:	No

Keywords provided by So Yeon Kim, Severance Hospital:


Robotic surgery Position Cardio Q hypotension

Additional relevant MeSH terms:

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Hypotension Vascular Diseases Cardiovascular Diseases

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