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Breath test could replace needles for checking pulse oximeters

NCT ID NCT03628560

Knowledge-focused Sponsor: Duke University Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Aug 11, 2026 · Last updated Aug 12, 2026 · Updated 1 time

Summary

This study tests whether using expired (end-tidal) oxygen values, instead of arterial blood samples, can accurately measure the performance of pulse oximeters. Healthy adults aged 18–50 will undergo controlled oxygen desaturation sequences using a device called RespirAct, which also regulates carbon dioxide levels. The goal is to see if this less invasive approach can validate pulse oximeter accuracy as reliably as traditional blood-based methods.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
RespirAct device sequences that control blood carbon dioxide levels to induce controlled oxygen desaturation
What this could lead to
If successful, this could make pulse oximeter validation faster, less invasive, and more accessible by reducing the need for arterial blood draws.
What could go wrong
This is a very small, early feasibility study with only two participants, so results may not generalize. The method must prove it matches the accuracy of traditional blood-based measurements.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

2 people

The number who actually took part.

Started

Sep 2018

Finished

Jan 2019

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 50 years

Sex

Anyone

Healthy volunteers

Accepted

You do not need to have the condition being studied to take part.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Aged 18 - 50 years * Subject is willing to provide written informed consent and is able to comply with anticipated study procedures Exclusion Criteria: * Body Mass Index (BMI) \< 18.0 or \> 30.0 * Known significant respiratory, cardiovascular or medical condition that precludes study participation as judged by investigator * Anemia \[hemoglobin value below lower range of normal for gender\] * Abnormal hemoglobin electrophoresis result * Exposure to nicotine \[positive test at screening or study day\] * Abnormal drug screen \[positive test at screening or on day of study\] * Positive pregnancy test for females \[serum test at screening; urine test on study day\] * Abnormal Allen's test for collateral circulation * Abnormal Electrocardiogram * Abnormal Pulmonary Function Test * Abnormal venous blood gas result * Intolerance of facemask

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Conditions

The condition(s) this trial relates to.

Hypoxia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Desaturation of blood Hypoxemia

Contacts and locations

Locations

  • Duke University

    Durham, North Carolina, 27710, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.