NCT02989441

Brief Summary

In patients under general anesthesia the investigators wish to investigate association and covariance between a peripheral perfusion index as obtained by Radical 7 monitor (Masimo, Irvine, CA, USA) and more traditional hemodynamic parameters, ie. invasive blood pressure and SV as obtained by LiDCO rapid monitor (LiDCO Ldt., London, UK)

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Nov 2016

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

Study Start

First participant enrolled

November 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 7, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

December 12, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2018

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2018

Completed
Last Updated

August 17, 2018

Status Verified

August 1, 2018

Enrollment Period

1.3 years

First QC Date

December 7, 2016

Last Update Submit

August 16, 2018

Conditions

Monitoring, Physiological

Keywords

Perfusion IndexHemodynamicsAnesthesiaStroke Volume

Outcome Measures

Primary Outcomes (1)

  • Co-variance between Perfusion Index (PI) and Cardiac Output (CO) and Stroke Volume (SV)

    Intra-operative

Secondary Outcomes (1)

  • Co-variance between Perfusion Index (PI) and Mean Arterial Pressure (MAP)

    Intra-operative

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients for elective and sub-acute surgical repair of para-oesophagal hernia.

You may qualify if:

  • Patients for elective and sub-acute surgical repair of para-oesophagal hernia.
  • Willingness to participate

You may not qualify if:

  • Patient refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hvidovre University Hospital

Hvidovre, Capital Region, DK-2650, Denmark

Location

Study Officials

  • Nicolai B Foss, MD PhD

    Hvidovre University Hospital, University of Copenhagen

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

December 7, 2016

First Posted

December 12, 2016

Study Start

November 1, 2016

Primary Completion

March 1, 2018

Study Completion

June 1, 2018

Last Updated

August 17, 2018

Record last verified: 2018-08

Locations

DK(1)