Non-invasive Monitor in Endoscopic Invasive Procedure

NCT ID: NCT03292627

Last Updated: 2020-06-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

200 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-03

Study Completion Date

2019-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Cholangiopancreatography, Endoscopic Retrograde Endoscopic Ultrasonography

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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mid age

mid age: 50-70 years old

Portable Noninvasive Hemodynamic Monitor

Intervention Type DEVICE

A non-invasive monitor for estimating patient's heart contractility and cardiac output by the change of thoracic electrical bioimpedance.

old age

old age: age older than 70 years old

Portable Noninvasive Hemodynamic Monitor

Intervention Type DEVICE

A non-invasive monitor for estimating patient's heart contractility and cardiac output by the change of thoracic electrical bioimpedance.

Interventions

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Portable Noninvasive Hemodynamic Monitor

A non-invasive monitor for estimating patient's heart contractility and cardiac output by the change of thoracic electrical bioimpedance.

Intervention Type DEVICE

Other Intervention Names

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The ICON™ monitor

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

\-
Minimum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Taiwan University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Hsiu-po Wang, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

National Taiwan University Hospital

Locations

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National Taiwan University Hospital

Taipei, , Taiwan

Site Status

Countries

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Taiwan

Other Identifiers

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201612030RINA

Identifier Type: -

Identifier Source: org_study_id

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