NCT01128036

Brief Summary

The purpose of this study is to determine if the forehand location for sensor placement has less episodes of signal dropout than the finger sensor location. In addition, this study will evaluate two finger sensors, which utilize different technology to compare signal quality.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
51

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started May 2010

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

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

May 1, 2010

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

May 20, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 21, 2010

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

August 9, 2011

Status Verified

August 1, 2011

Enrollment Period

1 year

First QC Date

May 20, 2010

Last Update Submit

August 8, 2011

Conditions

Keywords

Congestive Heart failureCardiomyopathy

Outcome Measures

Primary Outcomes (1)

  • Signal quality loss (dropout rate)

    Every 2 seconds for one hour

Study Arms (1)

CHF, cardomyopathy

Patients with signs of poor peripheral perfusion due to cardiomyopathy or congestive heart failure

Eligibility Criteria

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

Patients admitted to the CICU (Coronary Intensive Coronary Unit) with congestive heart failure or cardiomyopathy

You may qualify if:

  • CICU patients with a new diagnosis or history of CHF or cardiomyopathy
  • Patients with a medical order for pulse oximetry monitoring
  • Age greater than or equal to 18 years of age
  • English speaking
  • Signs of hypoperfusion

You may not qualify if:

  • CICU patients with an impediment to sensor application
  • CICU patients with excessive facial edema
  • CICU patients with mechanical ventilation
  • CICU patients with intra-aortic balloon pump therapy
  • CICU patients with intravenous vasopressor drug administration

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Saint Luke's Hospital

Kansas City, Missouri, 64111, United States

Location

MeSH Terms

Conditions

Heart FailureCardiomyopathies

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Lisa Riggs, MSN

    Saint Luke's Hospital

    STUDY DIRECTOR
  • Marci Sportsman, BSN

    Saint Luke's Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 20, 2010

First Posted

May 21, 2010

Study Start

May 1, 2010

Primary Completion

May 1, 2011

Study Completion

May 1, 2011

Last Updated

August 9, 2011

Record last verified: 2011-08

Locations