NCT06022523

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Nov 2022

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

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 9, 2022

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

November 30, 2022

Completed
9 months until next milestone

First Posted

Study publicly available on registry

September 5, 2023

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 9, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 9, 2024

Completed
Last Updated

September 5, 2023

Status Verified

August 1, 2023

Enrollment Period

2 years

First QC Date

November 30, 2022

Last Update Submit

August 30, 2023

Conditions

Hypoxemia

Keywords

HypoxiaPulse oximetry

Outcome Measures

Primary Outcomes (1)

  • 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

    Within 12 months of subject recruitment

Study Arms (1)

Acquisition

EXPERIMENTAL

Subjects will undergo profound hypoxia with stable plateaus.

Diagnostic Test: Data acquisition using DT-400 pulse oximetry system

Interventions

Data acquisition using DT-400 pulse oximetry systemDIAGNOSTIC_TEST

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

Acquisition

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may not qualify if:

  • Pregnancy -

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Consolidated Research, Inc.

Cleveland, Ohio, 44132, United States

RECRUITING

MeSH Terms

Conditions

Hypoxia

Condition Hierarchy (Ancestors)

Signs and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and Symptoms

Study Design

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

Study Record Dates

First Submitted

November 30, 2022

First Posted

September 5, 2023

Study Start

November 9, 2022

Primary Completion

November 9, 2024

Study Completion

November 9, 2024

Last Updated

September 5, 2023

Record last verified: 2023-08

Locations

US(1)