NCT02557009

Brief Summary

The study is designed as a prospective observational study. Each participant will have their BP, CVP, PAP, and CO measured by their clinical nurse using indwelling catheters placed for routine patient monitoring. Measurements will be recorded on an hourly basis during the day and for as many days as possible if the required measurements are being made for clinical care. Sixty patients between 18 and 85 years of age will be recruited in HVICU by means of convenience sampling. Data will be analyzed using a test of equivalence on the initial measurements (test of equivalence between two means) and then over time (repeated measurements) with a linear mixed-effects model.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Oct 2013

Typical duration 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

Study Start

First participant enrolled

October 1, 2013

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

September 21, 2015

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 22, 2015

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2016

Completed
Last Updated

July 25, 2017

Status Verified

July 1, 2017

Enrollment Period

2.8 years

First QC Date

September 21, 2015

Last Update Submit

July 24, 2017

Conditions

Blood Pressure

Keywords

HemodynamicsCentral Venous PressurePulmonary Artery PressureCardiac Output

Outcome Measures

Primary Outcomes (1)

  • central venous pressure supine and with head of bed at 30 degrees

    48 hours post-operatively

Secondary Outcomes (2)

  • cardiac output supine

    48 hours post-operatively

  • cardiac output with head of bed at 30 degrees

    48 hours post-operatively

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients at Hershey Medical Center having CABG and aortic valve surgery

You may qualify if:

  • Adult patients (18 to 85 years of age) in the HVICU
  • Have indwelling CVP or PA catheter.

You may not qualify if:

  • Patients who have just undergone mitral valve surgery
  • Patients that have PEEP \> 10cmH2O

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Penn State Milton S Hershey Medical Center

Hershey, Pennsylvania, 17033, United States

Location

Study Officials

  • Kane High, MD

    MS Hershey Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

September 21, 2015

First Posted

September 22, 2015

Study Start

October 1, 2013

Primary Completion

July 1, 2016

Study Completion

July 1, 2016

Last Updated

July 25, 2017

Record last verified: 2017-07

Locations

US(1)