NCT02129959

Brief Summary

The aim of this study is to observe the cardiovascular effects of the degree of head-down angle and pneumoperitoneum during laparoscopic procedure using by the fourth version Vigileo-Flotrac system.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
180

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

May 1, 2014

Completed
Same day until next milestone

Study Start

First participant enrolled

May 1, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 2, 2014

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2015

Completed
Last Updated

May 2, 2014

Status Verified

May 1, 2014

Enrollment Period

10 months

First QC Date

May 1, 2014

Last Update Submit

May 1, 2014

Conditions

Laparoscopy

Keywords

laparoscopic cholecystectomy, laparoscopic gastrectomy, laparoscopic colectomy, laparoscopic appendectomy, laparoscopicassisted vaginal hysterectomy, robot-assisted laparoscopic radical prostatectomy

Outcome Measures

Primary Outcomes (1)

  • cardiovascular effects

    Hemodynamic data are recorded immediately after induction of anesthesia; 5 min after induction of pneumoperitoneum; 5, 15, 30, 60 min, and every 30 min if duration more than 60 min after placement in the Trendelenburg position with pneumoperitoneum; and the end.

    one year

Study Arms (1)

laparoscopy

laparoscopic cholecystectomy, laparoscopic gastrectomy, laparoscopic colectomy, laparoscopic appendectomy, laparoscopic assisted vaginal hysterectomy, robot-assisted laparoscopic radical prostatectomy

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

180 ASA physical status I to III patients undergoing laparoscopic surgery are enrolled in this study.

You may qualify if:

  • ASA physical status I to III patients undergoing laparoscopic surgery are enrolled in this study.

You may not qualify if:

  • preoperative ECG reports and severe obesity (body mass index ≥35 kg/m2)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NTUH

Taipei, Taiwan, 100, Taiwan

Location

Central Study Contacts

Peilin Lin, PhD

CONTACT

886-2-23123456pll5611@ntu.edu.tw

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
VS

Study Record Dates

First Submitted

May 1, 2014

First Posted

May 2, 2014

Study Start

May 1, 2014

Primary Completion

March 1, 2015

Last Updated

May 2, 2014

Record last verified: 2014-05

Locations

TW(1)