Ability of Cardio Q for Prediction of Hypotension

Sponsor

Severance Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT03882697

Collaborator

(none)

125

Enrollment

Locations

20.8

Actual Duration (Months)

62.5

Patients Per Site

Patients Per Site Per Month

Study Details

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	Intervention/Treatment	Phase
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

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 :

Jan 1, 2019

Actual Primary Completion Date :

Sep 24, 2020

Actual Study Completion Date :

Sep 24, 2020

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 85 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Severance Hospital, Yonsei University College of Medicine	Seoul		Korea, Republic of
2	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

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

So Yeon Kim, Associate professor, Severance Hospital

ClinicalTrials.gov Identifier:

NCT03882697

Other Study ID Numbers:

4-2018-0976

First Posted:

Mar 20, 2019

Last Update Posted:

Dec 21, 2020

Last Verified:

Dec 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by So Yeon Kim, Associate professor, Severance Hospital

Additional relevant MeSH terms:

Hypotension

Study Results

No Results Posted as of Dec 21, 2020