NCT01184521

Brief Summary

This is a study to evaluate the accuracy of the Masimo Rainbow SET Pulse CO-Oximeter in monitoring the hemoglobin levels of patients undergoing isovolemic hemodilution.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2010

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

August 17, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 19, 2010

Completed
13 days until next milestone

Study Start

First participant enrolled

September 1, 2010

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
Last Updated

January 31, 2012

Status Verified

January 1, 2012

Enrollment Period

10 months

First QC Date

August 17, 2010

Last Update Submit

January 27, 2012

Conditions

Cardiac Surgical Procedures

Outcome Measures

Primary Outcomes (1)

  • hemoglobin value

    The accuracy of the hemoglobin value from the Masimo pulse oximeter during isovolemic hemodilution.

    1 Day (day of surgery)

Study Arms (1)

pulse CO-oximeter

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients requiring isovolemic hemodilution during surgery.

You may qualify if:

  • Any subject that is scheduled to have isovolemic hemodilution

You may not qualify if:

  • Anything that prevents a subject from having isovolemic hemodilution

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nationwide Children's Hospital

Columbus, Ohio, 43147, United States

Location

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chairman Dept. of Anesthesiology & Pain Medicine

Study Record Dates

First Submitted

August 17, 2010

First Posted

August 19, 2010

Study Start

September 1, 2010

Primary Completion

July 1, 2011

Study Completion

July 1, 2011

Last Updated

January 31, 2012

Record last verified: 2012-01

Locations

US(1)