NCT03124927

Brief Summary

In this study, the level of methemoglobin (HbMet) will be increased in a controlled manner by administering sodium nitrite intravenously in healthy volunteers. The accuracy of a noninvasive HbMet measurement by a DCI pulse oximeter sensor will be assessed by comparison to blood measurements from a laboratory analyzer.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
25

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Apr 2008

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

2 active sites

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

April 23, 2008

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 8, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 8, 2008

Completed
8.7 years until next milestone

First Submitted

Initial submission to the registry

April 14, 2017

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 24, 2017

Completed
2 months until next milestone

Results Posted

Study results publicly available

June 12, 2017

Completed
Last Updated

June 12, 2017

Status Verified

May 1, 2017

Enrollment Period

4 months

First QC Date

April 14, 2017

Results QC Date

May 8, 2017

Last Update Submit

May 8, 2017

Conditions

Healthy

Outcome Measures

Primary Outcomes (1)

  • Accuracy of Sensor by Arms Calculation

    Accuracy will be determined by comparing the noninvasive blood methemoglobin measurement of the pulse oximeter to that obtained from a blood sample and calculating the arithmetic root mean square (Arms) error value.

    5 hours

Study Arms (1)

Test Group

EXPERIMENTAL

All subjects are enrolled into the test group and all subjects receive DCI pulse oximeter sensor.

Device: DCI pulse oximeter sensor

Interventions

DCI pulse oximeter sensorDEVICE
Test Group

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects must understand and consent to be in the study
  • American Society of Anesthesiology Class I (Healthy subjects without any systemic disease at all).

You may not qualify if:

  • Subjects who have any systemic disease at all.
  • Subjects who do not understand the study and the risks involved.
  • Current smokers.
  • Subjects who are pregnant.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

University of Arizona

Tucson, Arizona, 85724, United States

Location

University of California, San Francisco

San Francisco, California, 94143, United States

Location

Results Point of Contact

Title
Vikram Ramakanth
Organization
Masimo Corporation
clinicalresearchdept@masimo.com

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
LTE60
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 14, 2017

First Posted

April 24, 2017

Study Start

April 23, 2008

Primary Completion

August 8, 2008

Study Completion

August 8, 2008

Last Updated

June 12, 2017

Results First Posted

June 12, 2017

Record last verified: 2017-05

Locations

US(2)