## Protocol Section
### Identification Module
**NCT ID:** NCT02870179

**Brief Title:** Oxitone Sp02 Hypoxia Test Versus Reference Pulse Oximetry

**Official Title:** Oxitone Sp02 Hypoxia Test Versus Reference Pulse Oximetry

#### Organization Study ID Info
**ID:** PR 2016-191
#### Organization
**Class:** INDUSTRY
**Full Name:** Oxitone Medical Ltd.
### Status Module
#### Completion Date
**Date:** 2016-09

**Type:** ACTUAL

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2017-04-20

**Type:** ACTUAL

**Last Update Submit Date:** 2017-04-19

**Overall Status:** COMPLETED

#### Primary Completion Date
**Date:** 2016-09

**Type:** ACTUAL

#### Start Date
**Date:** 2016-08

**Type:** ACTUAL

**Status Verified Date:** 2017-04

#### Study First Post Date
**Date:** 2016-08-17
**Type:** ESTIMATED
**Study First Submit Date:** 2016-08-10
**Study First Submit QC Date:** 2016-08-12
### Sponsor Collaborators Module

#### Collaborators

**Class:** OTHER

**Name:** Clinimark, LLC

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** Oxitone Medical Ltd.

#### Responsible Party

**Investigator Affiliation:** Oxitone Medical Ltd.

**Investigator Full Name:** Leon Eisen, PhD

**Investigator Title:** Leon Eisen, CEO

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** The purpose of this study is to conduct a SpO2 hypoxia evaluation of the Oxitone Medical Oxitone 1000 pulse oximeter. The Oxitone 1000 pulse oximeter will be evaluated during non-motion conditions over the range of 70-100% SpO2 in comparison to a Reference Pulse Oximeter.

The study is observational in nature which quantifies device performance and accuracy in compassion to a Reference Pulse Oximeter.

**Detailed Description:** The purpose of this study is to conduct a SpO2 hypoxia evaluation of the Oxitone Medical Oxitone 1000 pulse oximeter. The Oxitone 1000 pulse oximeter will be evaluated during non-motion conditions over the range of 70-100% SpO2 in comparison to a Reference Pulse Oximeter. The end goal is to show the SpO2 accuracy performance of the Oxitone 1000 and if needed, use the data to make improvements prior to an arterial blood hypoxia study.

A Clinimark 3900 Reference Pulse Oximeter or Nellcor N-600x will be used for the SpO2 calibration. There are no risks or adverse device effects to be assessed. There are no contraindications for use in the proposed study / study population

The Control Pulse Oximeter, GE Healthcare (Datex-Ohmeda) 3900, an FDA cleared device, is used to monitor the oxygen saturation levels real time throughout the study for subject safety and to target stable plateaus. This device is used to assess the stability of the data.

### Conditions Module

**Conditions:**

- Hypoxia

**Keywords:**

- Pulse Oximetry

- Temperature

- Respiratory Rate

- Respiratory Gases

- This study determines the measurement accuracy of the physiological parameters

### Design Module

#### Design Info

**Observational Model:** CASE_ONLY

**Time Perspective:** PROSPECTIVE

#### Enrollment Info

**Count:** 11

**Type:** ACTUAL

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** Smoker or non-smoker

**Intervention Names:**

- Device: Pulse Oximeter

**Label:** Healthy volunteer

### Interventions

#### Intervention 1

**Arm Group Labels:**

- Healthy volunteer

**Description:** Measurement of physiological parameters

**Name:** Pulse Oximeter

**Other Names:**

- Blood Pressure

- Respiratory Rate

- Respiratory Gassess

- Temperature

**Type:** DEVICE

### Outcomes Module

#### Primary Outcomes

**Description:** Data is collected in a digital form for 4-6 SpO2 stable plateaus in a specified range from 100% to 70%.

**Measure:** Collect SpO2 data for accuracy statistical analysis by 12 subjects

**Time Frame:** 2 months

**Description:** Bland-Altman graphical plots. An Accuracy Root Mean Square (ARMS) calculation is used as a means to define the SpO2 accuracy. Data analysis will follow ISO80601-2-61, Annex EE and the FDA Guidance Document for Pulse Oximeters (Martch 4, 2013).

**Measure:** Accuracy data analysis

**Time Frame:** 2 months

#### Secondary Outcomes

**Description:** SpO2 versus (SpO2-Ref SpO2) will be generated with linear regression fit, mean, and upper 95% and lower 95% limits of agreement.

**Measure:** Error plots

**Time Frame:** 2 months

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* Healthy individuals between the age of 18-50

Exclusion Criteria:

* Clotting disorders, diabetes, currently taking psychotropic medications

**Healthy Volunteers:** True

**Maximum Age:** 50 Years

**Minimum Age:** 18 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- ADULT

**Study Population:** Residents of the Denver metropolitan area

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** Louisville

**Country:** United States

**Facility:** Clinimark Laboratories

**State:** Colorado

**Zip:** 80027

#### Overall Officials

**Official 1:**

**Affiliation:** Oxitone Medical Ltd.

**Name:** Leon Eisen, PhD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000012818

- Term: Signs and Symptoms, Respiratory

### Condition Browse Module - Browse Branches

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: All

- Name: All Conditions

### Condition Browse Module - Browse Leaves

- ID: M4185

- Name: Hypoxia

- Relevance: HIGH

- As Found: Hypoxia

- ID: M15623

- Name: Signs and Symptoms, Respiratory

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000000860

- Term: Hypoxia

### Misc Info Module

- Version Holder: 2024-05-24
