Non-invasive Monitor in Endoscopic Invasive Procedure

Applying Non-invasive Hemodynamic Monitor to Predict the Risk of Perioperative Hypotension in Geriatric Patients Underwent Endoscopic Invasive Procedure

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.

Study Overview

• Status: Completed
• Conditions: Cholangiopancreatography, Endoscopic Retrograde; Endoscopic Ultrasonography
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Actual): 200

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 100
    • National Taiwan University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Investigators are trying to find the non-invasive predictor of perioperative hypotension in geriatric group. Investigator collected the patients who need painless endoscopic invasive procedure, investigator record their hemodynamic data including estimated cardiac output (CCO)，index of contractility (ICON)，NBP，HR，and saturation. Investigator wants to find that weather geriatric group has more risk of perioperative hypotension.

Description

Inclusion Criteria:

• patient who need painless endoscopic invasive procedures
• age above 50 y/o

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
ICON decrease 40%	estimated index of contractility decrease 40%	during the painless procedure

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
perioperative hypotension 40%	BP decrease 40%	during the painless procedure

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): October 3, 2017
• Primary Completion (Actual): July 31, 2019
• Study Completion (Actual): July 31, 2019

Study Registration Dates

• First Submitted: September 20, 2017
• First Submitted That Met QC Criteria: September 20, 2017
• First Posted (Actual): September 25, 2017

Study Record Updates

• Last Update Posted (Actual): June 5, 2020
• Last Update Submitted That Met QC Criteria: June 4, 2020
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Other Study ID Numbers: 201612030RINA

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No