Recruiting

Observational Study

Sponsor:

Consolidated Research, Inc.

Code:

NCT06022523

Conditions

Hypoxemia

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Interventions

Data acquisition using DT-400 pulse oximetry system

Study Details

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.

Conditions

Hypoxemia

Study ID

NCT06022523

Start date

Nov 9, 2022

Status verified date

Aug, 2023

Completion date

Nov 9, 2024

Anticipated

Primary completion date

Nov 9, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 55

Healthy Volunteers: Accepted

Inclusion Criteria:

-

Exclusion Criteria:

Pregnancy -

Study Design

Enrollment

30 participants

Anticipated

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Arms

experimental: Acquisition

Subjects will undergo profound hypoxia with stable plateaus.

Interventions

Data acquisition using DT-400 pulse oximetry system

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

Primary outcome measure

  • Saturation level measurement [ Time Frame: Within 12 months of subject recruitment ]

Central Contacts and Locations

Locations

Consolidated Research, Inc.

Recruiting

Cleveland, Ohio, United States, 44132

Contacts

Richard Kaplan, Ph.D.

216-289-2331kaplan@cri-systems.com

More Information

Sponsor

Consolidated Research, Inc.

Last update posted

Sep 5, 2023

Last verified

Aug, 2023

Keywords

  • Hypoxia
  • Pulse oximetry

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Consolidated Research, Inc. on 2023-09-05.