Clinical trial NCT03292627: Non-invasive Monitor in Endoscopic Invasive Procedure
Official title: Applying Non-invasive Hemodynamic Monitor to Predict the Risk of Perioperative Hypotension in Geriatric Patients Underwent Endoscopic Invasive Procedure
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cholangiopancreatography, Endoscopic Retrograde
Endoscopic Ultrasonography
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2017-09-25
Enrollment: 200
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Investigators are trying to find the non-invasive predictor of perioperative hypotension in geriatric group. Investigator collected the patients who need painless endoscopic invasive procedure, investigator record their hemodynamic data including estimated cardiac output (CCO)，index of contractility (ICON)，NBP，HR，and saturation. Investigator wants to find that weather geriatric group has more risk of perioperative hypotension.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

-

Primary outcomes:
measure: ICON decrease 40%
timeFrame: during the painless procedure
Secondary outcomes:
measure: perioperative hypotension 40%
timeFrame: during the painless procedure
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
Study officials:
affiliation: National Taiwan University Hospital
name: Hsiu-po Wang, M.D., Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: