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Clinical Trials/NCT03292627
NCT03292627
Completed
N/A

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

National Taiwan University Hospital1 site in 1 country200 target enrollmentOctober 3, 2017

Overview

Phase
N/A
Intervention
Not specified
Conditions
Cholangiopancreatography, Endoscopic Retrograde
Sponsor
National Taiwan University Hospital
Enrollment
200
Locations
1
Primary Endpoint
ICON decrease 40%
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 3, 2017
End Date
July 31, 2019
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

ICON decrease 40%

Time Frame: during the painless procedure

estimated index of contractility decrease 40%

Secondary Outcomes

  • perioperative hypotension 40%(during the painless procedure)

Study Sites (1)

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