NCT03047850

Brief Summary

Delta Pulse Pressure and Delta Down have been validated in surgery upon closed chest. This study aim to evaluate the influence of sternotomy on the value of Delta Pulse Pressure and Delta Down.

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 Jul 2017

Shorter than P25 for all trials

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

February 6, 2017

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 9, 2017

Completed
5 months until next milestone

Study Start

First participant enrolled

July 1, 2017

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2017

Completed
Last Updated

June 19, 2018

Status Verified

June 1, 2018

Enrollment Period

5 months

First QC Date

February 6, 2017

Last Update Submit

June 18, 2018

Conditions

Hemodynamics

Keywords

Sternotomy

Outcome Measures

Primary Outcomes (2)

  • Change of Delta Pulse Pressure Value

    Change of Delta Pulse Pressure Value before and after sternotomy.

    10 minutes

  • Change of Delta Down Value

    Change of Delta Down before and after sternotomy.

    10 minutes

Study Arms (1)

Study Group

All patients included in this study.

Diagnostic Test: Comparison of Delta Down and Delta Pulse Pressure

Interventions

Comparison of Delta Down and Delta Pulse PressureDIAGNOSTIC_TEST

Comparison of Delta Down and Delta Pulse Pressure Before and After Sternotomy.

Study Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients scheduled for open chest surgery.

You may qualify if:

  • All patients scheduled for open chest surgery.

You may not qualify if:

  • Age \< 18 years
  • Patients with arrhythmia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinique Saint-Luc of Bouge

Bouge, Namur, 5001, Belgium

Location

Study Officials

  • Eric DEFLANDRE, MD, FCCP

    Astes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

February 6, 2017

First Posted

February 9, 2017

Study Start

July 1, 2017

Primary Completion

November 30, 2017

Study Completion

December 31, 2017

Last Updated

June 19, 2018

Record last verified: 2018-06

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)