Ability of Cardio Q for Prediction of Hypotension

NCT03882697 | Completed DMC

• 1 other identifier: 4-2018-0976
• Study Type: observational
• Target: 125
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Prostate Cancer

Keywords

Robotic surgery; Position; Cardio Q; hypotension

Outcome Measures

Primary Outcomes (1)

• Mean arterial pressure

  The changes mean arterial pressure

  Before position change, After position change (1, 3, 5, 7, and 10 minutes)

Eligibility Criteria

• Age: 20 Years - 85 Years
• Gender Eligibility Details: Only male can have prostate
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• Severance Hospital: lead

Study Sites (2)

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

Seoul, South Korea

Location

Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine

Seoul, South Korea

Location

Related Publications (1)

• 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.

  PMID: 34272425 DERIVED

MeSH Terms

Conditions

Prostatic Neoplasms; Hypotension

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Vascular Diseases; Cardiovascular Diseases

Study Officials

• So Yeon Kim, MD, PhD

  Severance Hospital, Yonsei University College of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: February 12, 2019
• First Posted: March 20, 2019
• Study Start: January 1, 2019
• Primary Completion: September 24, 2020
• Study Completion: September 24, 2020
• Last Updated: December 21, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (2)