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Non-invasive Monitor in Endoscopic Invasive Procedure

Sponsor
National Taiwan University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03292627
Collaborator
(none)
200
Enrollment
1
Location
21.9
Actual Duration (Months)
9.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Investigators include the patients who need painless invasive endoscopic procedure, investigators collect the demographic data and apply the non-invasive device ICON on participants during the who procedure.

Condition or Disease Intervention/Treatment Phase
  • Device: Portable Noninvasive Hemodynamic Monitor

Detailed Description

Invasive endoscopy procedure including Endoscopic Retrograde Cholangio-Pancreatography (ERCP), endoscopic ultrasound guided fine needle aspiration (EUS-FNA), Endoscopic Retrograde Biliary Drainage (ERBD) and others is more and more popular which become the standard treatment before surgical intervention. However; the elder group who need this procedure is getting more common. The painless endoscopic sedation for elder group who has more comorbidity is not easy. During the procedure, the investigators found that the anticholinergic medication-buscopam which in order to suppress intestine mobilization can cause obvious tachycardia. Tachycardia makes the stroke volume decrease which enhance the perioperative hypotension, and the vasodilation effect of the analgesics make it worse.

Investigators are trying to find the non-invasive predictor of perioperative hypotension in geriatric group. Investigators collected the patients who need painless endoscopic invasive procedure, investigators will record their hemodynamic data including estimated cardiac output (CCO)，index of contractility (ICON)，NBP，HR，and saturation. Investigators also add the evaluation of frailty to evaluate the relationship between frailty and perioperative complications.

Study Design

Study Type:
Observational
Actual Enrollment :
200 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
Applying Non-invasive Hemodynamic Monitor to Predict the Risk of Perioperative Hypotension in Geriatric Patients Underwent Endoscopic Invasive Procedure
Actual Study Start Date :
Oct 3, 2017
Actual Primary Completion Date :
Jul 31, 2019
Actual Study Completion Date :
Jul 31, 2019

Arms and Interventions

Arm Intervention/Treatment
mid age

mid age: 50-70 years old

Device: Portable Noninvasive Hemodynamic Monitor
A non-invasive monitor for estimating patient's heart contractility and cardiac output by the change of thoracic electrical bioimpedance.
Other Names:
  • The ICON™ monitor

    		•
    old age

    old age: age older than 70 years old

    Device: Portable Noninvasive Hemodynamic Monitor
    A non-invasive monitor for estimating patient's heart contractility and cardiac output by the change of thoracic electrical bioimpedance.
    Other Names:
  • The ICON™ monitor

    		•

    Outcome Measures

    Primary Outcome Measures

    1. ICON decrease 40% [during the painless procedure]

      estimated index of contractility decrease 40%

    Secondary Outcome Measures

    1. perioperative hypotension 40% [during the painless procedure]

      BP decrease 40%

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    50 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • patient who need painless endoscopic invasive procedures

    • age above 50 y/o

    Exclusion Criteria:

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 National Taiwan University Hospital Taipei Taiwan 100

    Sponsors and Collaborators

    • National Taiwan University Hospital

    Investigators

    • Principal Investigator: Hsiu-po Wang, M.D., Ph.D., National Taiwan University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    National Taiwan University Hospital
    ClinicalTrials.gov Identifier:
    NCT03292627
    Other Study ID Numbers:
    • 201612030RINA
    First Posted:
    Sep 25, 2017
    Last Update Posted:
    Jun 5, 2020
    Last Verified:
    Sep 1, 2018
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No

    Study Results

    No Results Posted as of Jun 5, 2020