NCT03081793

Brief Summary

The aim of the study is to the reliability and feasibility of a novel optical heart rate monitor in hospital patients. Especially patients with atrial fibrillation are included. Patients will be monitored for two hours during routine post-operative care. The data from study device will be compared to routine monitoring. The design of the study is a Pilot feasibility study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 10, 2017

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 16, 2017

Completed
2 months until next milestone

Study Start

First participant enrolled

May 1, 2017

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 30, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2017

Completed
Last Updated

September 19, 2017

Status Verified

September 1, 2017

Enrollment Period

4 months

First QC Date

March 10, 2017

Last Update Submit

September 18, 2017

Conditions

Atrial Fibrillation

Keywords

postoperative monitoringplethysmographymonitoring

Outcome Measures

Primary Outcomes (1)

  • Recognition of the rhythm

    To verify that average heart rate (HR) and beat-to-beat heart rate estimation is reliable also with hospital patients having either normal sinus rhythm, atrial fibrillation, or other arrhythmia

    2 hours

Secondary Outcomes (2)

  • quantification of estimation errors

    2 hours

  • identification of PPG morphology

    2 hours

Study Arms (2)

Patients with sinus Rhythm

Patients with sinus rhythm at the beginning of monitoring

Atrial fibrillation

Patients with atrial fibrillation at the beginning of monitoring

Eligibility Criteria

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

Patients subjected to surgery requiring post-operative care. A heterogenous sample of patients with atrial fibrillation and patients with sinus rhytm

You may qualify if:

  • Age: \> 18 years
  • Subjected to surgery at Tampere University Hospital
  • Spontaneously ventilating
  • Volunteering for the study
  • Able to give a written informed consent

You may not qualify if:

  • Having a cardiac pacemaker
  • Surgical operation performed in wrist area or any other reason that prevents placing the wrist-worn device in correct location
  • Neurological disease (e.g. Parkinson's) possibly causing notable amount of shivering
  • Non-Caucasian skin colour
  • Inability to give an informed consent
  • Denial of participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tampere University Hospital

Tampere, 33521, Finland

Location

MeSH Terms

Conditions

Atrial Fibrillation

Condition Hierarchy (Ancestors)

Arrhythmias, CardiacHeart DiseasesCardiovascular DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 10, 2017

First Posted

March 16, 2017

Study Start

May 1, 2017

Primary Completion

August 30, 2017

Study Completion

August 30, 2017

Last Updated

September 19, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share

Locations

FI(1)