NCT02350608

Brief Summary

Observational study of 20 postoperative cardiac surgery patients. On admission to the ICU the patients will receive a noninvasive monitor recording arterial pulse waveform and ECG. The monitoring will continue to the ward for two days. The data will be compared with the routine monitoring methods.

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 Mar 2015

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

January 26, 2015

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 29, 2015

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2015

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
Last Updated

November 4, 2015

Status Verified

November 1, 2015

Enrollment Period

8 months

First QC Date

January 26, 2015

Last Update Submit

November 3, 2015

Conditions

Blood PressureArrhythmias, Cardiac

Outcome Measures

Primary Outcomes (1)

  • Detection of arrythmia

    2 days

Interventions

Noninvasive monitorDEVICE

A novel technique on noninvasive blood pressure monitoring.

Eligibility Criteria

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

Postoperative cardiac surgery patients

You may qualify if:

  • Adult cardiac surgery patients, informed consent

You may not qualify if:

  • Poor co-operation, age less than 18 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tampere University Hospital Heart Center

Tampere, 33521, Finland

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jari Laurikka, Prof

    Tampere UH

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Head of Cardiac Intensive Care Unit

Study Record Dates

First Submitted

January 26, 2015

First Posted

January 29, 2015

Study Start

March 1, 2015

Primary Completion

November 1, 2015

Study Completion

November 1, 2015

Last Updated

November 4, 2015

Record last verified: 2015-11

Locations

FI(1)