NCT01811342

Brief Summary

Evaluate potential sources of error that affect the accuracy of continuous hemoglobin monitoring.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Nov 2012

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

November 1, 2012

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

March 7, 2013

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 14, 2013

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

February 27, 2018

Status Verified

February 1, 2018

Enrollment Period

2.8 years

First QC Date

March 7, 2013

Last Update Submit

February 23, 2018

Conditions

Anemia

Keywords

HemoglobinPatient Monitoring

Outcome Measures

Primary Outcomes (1)

  • Evaluation of the Masimo Continuous Hemoglobin Monitor with Polar Plot Methodology

    Determine the influence of initial calibration and intraoperative oxygenation variables on the correlation between SpHgb and clinical values

    One year

Study Arms (1)

Hemoglobin Measurement

Patients requiring intra-operative hemoglobin measurement.

Eligibility Criteria

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

Patients undergoing elective surgery.

You may qualify if:

  • Patients undergoing elective surgery.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UC Davis Medical Center

Sacramento, California, 95817, United States

Location

MeSH Terms

Conditions

Anemia

Condition Hierarchy (Ancestors)

Hematologic DiseasesHemic and Lymphatic Diseases

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 7, 2013

First Posted

March 14, 2013

Study Start

November 1, 2012

Primary Completion

September 1, 2015

Study Completion

September 1, 2015

Last Updated

February 27, 2018

Record last verified: 2018-02

Locations

US(1)