Non-invasive Monitor in Endoscopic Invasive Procedure

Cholangiopancreatography, Endoscopic Retrograde Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03292627
• Other study ID #: 201612030RINA
• Status: Completed
• Start date: October 3, 2017
• Est. completion date: July 31, 2019

Study information

• Verified date: September 2018
• Source: National Taiwan University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 200
• Est. completion date: July 31, 2019
• Est. primary completion date: July 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

Inclusion Criteria:

• patient who need painless endoscopic invasive procedures

• age above 50 y/o

Exclusion Criteria:

-

Related Conditions & MeSH terms

• Cholangiopancreatography, Endoscopic Retrograde
• Endoscopic Ultrasonography

Intervention

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.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	ICON decrease 40%	estimated index of contractility decrease 40%	during the painless procedure
Secondary	perioperative hypotension 40%	BP decrease 40%	during the painless procedure