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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03292627

Enrollment

200

Registered

2017-09-25

Start date

2017-10-03

Completion date

2019-07-31

Last updated

2020-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cholangiopancreatography, Endoscopic Retrograde, Endoscopic Ultrasonography

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.

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.

Interventions

DEVICEPortable Noninvasive Hemodynamic Monitor

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

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

50 Years to No maximum

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

Design outcomes

Primary

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

Secondary

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

Countries

Taiwan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026