HypoxiaNCT06994663
Finger Pulse Oximeters in Hosptial Setting
An observational study of Hypoxia and Respiratory Failure With Hypoxia, run by Barts & The London NHS Trust.
Trial summary
Pulse oximetry is a well-established, non-invasive measurement tool used to estimate arterial oxygen saturation. The accuracy of these cheap, readily available finger pulse oximeters has not been robustly assessed in a clinical trial however. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Hypoxia, Respiratory Failure With Hypoxia
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 7 Dec 2015to 31 Oct 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: In hospital patients requiring blood gas sampling (Typically this would represent patients who are complaining of breathlessness or who have low oxygen saturations)
Who may be able to join
- Hospital inpatients deemed by the clinical team to require arterial blood gas sampling (Typically this would represent patients who are complaining of breathlessness or who have low oxygen saturations)
- Informed consent
Who cannot join
- Inability to consent (including language barrier)
- Age <16 years old
About this study
Official title: Evaluating the Accuracy of Commercially Available Finger Pulse Oximeters in a Hospital Setting
Pulse oximetry is a well-established, non-invasive measurement tool used to estimate arterial oxygen saturation. The accuracy of these cheap, readily available finger pulse oximeters has not been robustly assessed in a clinical trial however.
It is vital for clinical practice that this technology is reliable in tracking changes in oxygen saturations at times of ill health as varying physiological parameters may, in theory, contribute to inaccurate readings.
This study will investigate whether these new devices provide a sufficiently accurate measurement of oxygen levels in the blood (when compared to arterial blood gas sampling) to endorse their use in routine hospital practice.
Read the detailed description
The investigators propose to assess the margins of agreement between newer commercially available finger pulse oximeters and arterial blood gases in a hospital setting.
Eligible participants requiring blood gas assessment will be identified by members of the clinical team, who will inform the research team investigator. Arterial blood gas sampling is usually performed in patients who are breathless with low oxygen levels.
At the time of arterial blood gas sampling, the three finger pulse oximeters will be placed on each of three fingers of the participant.
The pulse oximeters are small cubic devices, each about the size of a matchbox that sits lightly over the fingernail. Light is emitted from the device and passes through the nailbed.The blood oxygen levels can then be estimated by measuring the absorption of different wavelengths of light. The participant will be asked to remain seated and still for 2mins until steady state is achieved. At this time readings will be taken from each machine.
The contemporaneous measurements of oxygen saturation using gold standard, invasive arterial blood gas sampling and new non-invasive portable pulse oximeters will allow the investigators to evaluate the accuracy of these devices and evaluate their clinical usefulness in the hospital setting.
- Conditions
- Hypoxia, Respiratory Failure With Hypoxia
- Medical subject headings
- Hypoxia
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlation
The handheld pulse oximeters will exhibit a good correlation as evidenced by the Intraclass correlation coefficient of 0.75. The cohort patients who were deemed by their treating physician to require an arterial blood gas sample had simultaneous SpO2 readings using 3 pulse oximeters (TempIR-Oxy, Jumper JPD-500A and Nonin Vantage 9590). Data were analysed using Pearson correlation co-efficient (r) and Bland Altman bias plot.
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2025
- Study start7 Dec 2015
- Primary completion31 Oct 2016
- Study completion31 Oct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypoxiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06994663
- Sponsor's protocol ID
- 010501
- Status last verified
- May 2025
- First submitted
- 17 Jan 2018
- Last updated
- 29 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Accuracy of Commercially Available Finger Pulse Oximeters in a Hospital Setting
- ClinicalTrials.gov ID
- NCT06994663
- Acronym / sponsor ID
- 010501
- Conditions
- Hypoxia, Respiratory Failure With Hypoxia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Study start
- 7 Dec 2015 (actual)
- Primary completion
- 31 Oct 2016 (actual)
- Study completion
- 31 Oct 2016 (actual)
- First posted
- 29 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pulse oximetry is a well-established, non-invasive measurement tool used to estimate arterial oxygen saturation. The accuracy of these cheap, readily available finger pulse oximeters has not been robustly assessed in a clinical trial however.
It is vital for clinical practice that this technology is reliable in tracking changes in oxygen saturations at times of ill health as varying physiological parameters may, in theory, contribute to inaccurate readings.
This study will investigate whether these new devices provide a sufficiently accurate measurement of oxygen levels in the blood (when compared to arterial blood gas sampling) to endorse their use in routine hospital practice.
Detailed description
The investigators propose to assess the margins of agreement between newer commercially available finger pulse oximeters and arterial blood gases in a hospital setting.
Eligible participants requiring blood gas assessment will be identified by members of the clinical team, who will inform the research team investigator. Arterial blood gas sampling is usually performed in patients who are breathless with low oxygen levels.
At the time of arterial blood gas sampling, the three finger pulse oximeters will be placed on each of three fingers of the participant.
The pulse oximeters are small cubic devices, each about the size of a matchbox that sits lightly over the fingernail. Light is emitted from the device and passes through the nailbed.The blood oxygen levels can then be estimated by measuring the absorption of different wavelengths of light. The participant will be asked to remain seated and still for 2mins until steady state is achieved. At this time readings will be taken from each machine.
The contemporaneous measurements of oxygen saturation using gold standard, invasive arterial blood gas sampling and new non-invasive portable pulse oximeters will allow the investigators to evaluate the accuracy of these devices and evaluate their clinical usefulness in the hospital setting.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- In hospital patients requiring blood gas sampling (Typically this would represent patients who are complaining of breathlessness or who have low oxygen saturations)
Key inclusion criteria (2 listed)
- Hospital inpatients deemed by the clinical team to require arterial blood gas sampling (Typically this would represent patients who are complaining of breathlessness or who have low oxygen saturations)
- Informed consent
Key exclusion criteria (2 listed)
- Inability to consent (including language barrier)
- Age <16 years old
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Correlation
Time frame: Baseline
The handheld pulse oximeters will exhibit a good correlation as evidenced by the Intraclass correlation coefficient of 0.75. The cohort patients who were deemed by their treating physician to require an arterial blood gas sample had simultaneous SpO2 readings using 3 pulse oximeters (TempIR-Oxy, Jumper JPD-500A and Nonin Vantage 9590). Data were analysed using Pearson correlation co-efficient (r) and Bland Altman bias plot.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypoxia and Respiratory Failure With Hypoxia, run by Barts & The London NHS Trust.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 May 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlation (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 May 2025.