Non-invasive Monitor in Endoscopic Invasive Procedure

Completed

• Conditions: Cholangiopancreatography, Endoscopic Retrograde; Endoscopic Ultrasonography
• Interventions: Device: Portable Noninvasive Hemodynamic Monitor

• Registration Number: NCT03292627
• Lead Sponsor: National Taiwan University Hospital

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.

Study Timeline

• Study First Submitted: 2017-09-20
• Study First Submitted QC: 2017-09-20
• Study First Posted: 2017-09-25
• Study Start: 2017-10-03
• Status Verified: 2018-09
• Primary Completion: 2019-07-31
• Study Completion: 2019-07-31
• Last Update Submitted: 2020-06-04
• Last Update Posted: 2020-06-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

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

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
mid age	Portable Noninvasive Hemodynamic Monitor	mid age: 50-70 years old
old age	Portable Noninvasive Hemodynamic Monitor	old age: age older than 70 years old

Primary Outcome Measures

Name	Time	Method
ICON decrease 40%	during the painless procedure	estimated index of contractility decrease 40%

Secondary Outcome Measures

Name	Time	Method
perioperative hypotension 40%	during the painless procedure	BP decrease 40%

Trial Locations

Locations (1)

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan