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Accuracy of Pulse Oximeters With Profound Hypoxia

Primary Purpose

Hypoxemia

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Data acquisition using DT-400 pulse oximetry system

About this trial

This is an interventional diagnostic trial for Hypoxemia focused on measuring Hypoxia, Pulse oximetry

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: - Exclusion Criteria: Pregnancy -

Sites / Locations

Consolidated Research, Inc.Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Acquisition

Arm Description

Subjects will undergo profound hypoxia with stable plateaus.

Outcomes

Primary Outcome Measures

Saturation level measurement

Induction of hypoxia by having subjects breathe mixtures of nitrogen, room air, and carbon dioxide to allow measurement of oxyhemoglobin saturation between 70-100%. Each plateau level of oxyhemoglobin saturation was maintained for at least 30 seconds or until reference pulse oximeters readings were stable

Secondary Outcome Measures

Full Information

NCT ID

NCT06022523

First Posted

November 30, 2022

Last Updated

August 30, 2023

Sponsor

Consolidated Research, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT06022523

Brief Title

Accuracy of Pulse Oximeters With Profound Hypoxia

Official Title

Accuracy of Pulse Oximeters With Profound Hypoxia

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

November 9, 2022 (Actual)

Primary Completion Date

November 9, 2024 (Anticipated)

Study Completion Date

November 9, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Consolidated Research, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

Device Product Not Approved or Cleared by U.S. FDA

Yes

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

The goal of this clinical trial is the acquisition of photoplethysmography signals during periods of profound hypoxia. The study is designed in accordance with ISO 80601- 2-61,2ed:2017-12 & 2018-02.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hypoxemia

Keywords

Hypoxia, Pulse oximetry

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Acquisition

Arm Type

Experimental

Arm Description

Subjects will undergo profound hypoxia with stable plateaus.

Intervention Type

Diagnostic Test

Intervention Name(s)

Data acquisition using DT-400 pulse oximetry system

Intervention Description

Acquisition of photopleth data during profound hypoxia using a Consolidated Research DT-400 pulse oximetry system.

Primary Outcome Measure Information:

Title

Saturation level measurement

Description

Time Frame

Within 12 months of subject recruitment

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

55 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: - Exclusion Criteria: Pregnancy -

Facility Information:

Facility Name

Consolidated Research, Inc.

City

Cleveland

State/Province

Ohio

ZIP/Postal Code

44132

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Richard Kaplan, Ph.D.

Phone

216-289-2331

kaplan@cri-systems.com

12. IPD Sharing Statement

Learn more about this trial

Accuracy of Pulse Oximeters With Profound Hypoxia

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