The Accuracy of the Dormotech VLAB During Stable Hypoxia... | NCT06516809

Studies
The Accuracy of the Dormotech VLAB During Stable Hypoxia Plateaus

NCT06516809

Sponsor

Dormotech Medical

Status

Completed

Last Update Posted

Jul 24, 2024Actual

Enrollment

12Actual

Phase

Not provided

Conditions

Healthy

Interventions

DormoTech Vlab SpO2 sensor

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 15, 2024Actual

Primary Completion Date

May 16, 2024Actual

Completion Date

May 30, 2024Actual

First Submitted Date

Jul 15, 2024

First Submission Date that Met QC Criteria

Jul 23, 2024

First Posted Date

Jul 24, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jul 23, 2024

Last Update Posted Date

Jul 24, 2024Actual

Description Module

Brief Summary

The purpose of the study is to determine the accuracy of the Dormotech VLAB (SpO2) Sensor in accordance with the FDA Guidance on Pulse Oximeters - Premarket Notification Submissions [510(k)s], in range of arterial HbO2 saturations from 100% down to 70%.

This was a prospective study with healthy volunteers.

The primary objective of the study was to determine the accuracy of the Dormotech VLAB sensor from saturations from 100 down to 70%. As the primary endpoint, the accuracy of the device during non-motion tests was determined by comparing the pulse oximeter reading during brief, steady-state hypoxia plateaus with a gold-standard measurement of blood oxyhemoglobin saturation (arterial blood sample processed in a multi-wavelength hemoximeter).

Detailed Description

The purpose of the study is to determine the accuracy of the Dormotech VLAB (SpO2) Sensor in accordance with the FDA Guidance on Pulse Oximeters - Premarket Notification Submissions [510(k)s], in the range of arterial HbO2 saturations from 100% down to 70%.

The subjects represent a diverse group in terms of age, height, weight, ethnicity, and skin types, which is beneficial for generalizing findings across different demographics. Subjects span all six types, indicating a wide range of skin types from very fair (Type I) to deeply pigmented dark (Type VI).

This was a prospective study with healthy volunteers.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

12Actual

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
DormoTech Vlab SpO2 sensor	Device	The Dormotech Vlab sensor was applied to one of the subject's forehead. Reference pulse oximeters were applied to the right fingers. Blood gas analysis to determine hemoglobin saturation (SaO2) was performed using an ABL-90 Flex Plus multi-wavelength oximeter (Hemoximeter, Radiometer, Copenhagen). The ABL90 Flex Plus contains factory calibration standards and automatically performs regular quality controls.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Measurement of arterial HbO2 saturations from 100% down to 70%	At the start of each testing cycle, one blood sample was taken while breathing room air. Subjects then breathed through a partial rebreathing circuit with a nose clip, a mixture of nitrogen, air and carbon dioxide to reach six different stable levels (plateaus) of oxyhemoglobin saturation between 70-100%.	day 1

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subject is male or Subject is male or female, aged 18 and < 50.
Subject is in good health with no evidence of any medical problems.
Subject is fluent in both written and spoken English.
Subject has provided informed consent and is willing to comply with the study procedure

Exclusion Criteria:

Subject is obese (BMI >35).
Subject has known history of heart disease, lung disease, kidney or liver disease.
Diagnosis of asthma, sleep apnea, or use of CPAP.
Subject has diabetes.
Subject has a clotting disorder.
Subject uses any anticoagulative medication (blood thinner).
Subject has a hemoglobinopathy or history of anemia, per subject report or the first blood sample, that in the opinion of the investigator, would make them unsuitable for study participation.
Subject has any other serious systemic illness.
Subject is a current smoker.
Subject with any injury, deformity, or abnormality at the sensor sites that in the opinion of the investigators would interfere with the sensors working correctly.
Subject has a history of fainting or vasovagal response.
Subject has a history of sensitivity to local anesthesia
Subject has a diagnosis of Raynaud's disease
Subject has claustrophobia
Subject has unacceptable collateral circulation based on exam by the investigator (Allen's test).
Subject is pregnant, lactating or trying to get pregnant.
Subject is unable or unwilling to provide informed consent or is unable or unwilling to comply with study procedures.
Subject has any other condition, which in the opinion of the investigators would make them unsuitable for the study.

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

50 Years

Standard Ages

Adult

Study Population

This was a prospective study with 12 healthy volunteers who met all the inclusion criteria and none of the exclusion criteria. Dormotech provided the investigational SpO2 sensors to conduct the evaluation with existing equipment at the site

Sampling Method

Non-Probability Sample