NCT03292627

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2017

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 20, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 25, 2017

Completed
8 days until next milestone

Study Start

First participant enrolled

October 3, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2019

Completed
Last Updated

June 5, 2020

Status Verified

September 1, 2018

Enrollment Period

1.8 years

First QC Date

September 20, 2017

Last Update Submit

June 4, 2020

Conditions

Cholangiopancreatography, Endoscopic RetrogradeEndoscopic Ultrasonography

Outcome Measures

Primary Outcomes (1)

  • ICON decrease 40%

    estimated index of contractility decrease 40%

    during the painless procedure

Secondary Outcomes (1)

  • perioperative hypotension 40%

    during the painless procedure

Study Arms (2)

mid age

mid age: 50-70 years old

Device: Portable Noninvasive Hemodynamic Monitor

old age

old age: age older than 70 years old

Device: Portable Noninvasive Hemodynamic Monitor

Interventions

Portable Noninvasive Hemodynamic MonitorDEVICE

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

Also known as: The ICON™ monitor
mid ageold age

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 100, Taiwan

Location

Study Officials

  • Hsiu-po Wang, M.D., Ph.D.

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 20, 2017

First Posted

September 25, 2017

Study Start

October 3, 2017

Primary Completion

July 31, 2019

Study Completion

July 31, 2019

Last Updated

June 5, 2020

Record last verified: 2018-09

Locations

TW(1)