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Ability of Cardio Q for Prediction of Hypotension

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ClinicalTrials.gov Identifier: NCT03882697
Recruitment Status : Recruiting
First Posted : March 20, 2019
Last Update Posted : March 22, 2019
Sponsor:
Information provided by (Responsible Party):
So Yeon Kim, Severance Hospital

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.


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Study Type : Observational
Estimated Enrollment : 100 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
Estimated Primary Completion Date : December 31, 2019
Estimated Study Completion Date : March 1, 2020

Resource links provided by the National Library of Medicine





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



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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.)

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


Contacts
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Contact: So Yeon Kim, MD, PhD 82-2-228-2429 KIMSY326@yuhs.ac

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 Recruiting
Seoul, Korea, Republic of
Contact: So Yeon Kim, MD, PhD    82-2-228-2429    KIMSY326@yuhs.ac   
Department of Anesthesiology and Pain Medicine and Anesthesia and Pain Research Institute, Yonsei University College of Medicine Recruiting
Seoul, Korea, Republic of
Contact: So Yeon Kim, MD, PhD    82-2-228-2429    KIMSY326@yuhs.ac   
Principal Investigator: So Yeon Kim, MD, PhD         
Sponsors and Collaborators
Severance Hospital
Investigators
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Principal Investigator: So Yeon Kim, MD, PhD Severance Hospital, Yonsei University College of Medicine

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Responsible Party: So Yeon Kim, Associate professor, Severance Hospital
ClinicalTrials.gov Identifier: NCT03882697     History of Changes
Other Study ID Numbers: 4-2018-0976
First Posted: March 20, 2019    Key Record Dates
Last Update Posted: March 22, 2019
Last Verified: March 2019
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