Sleep ApneaNCT04474574
How Differences in Oximeter Performance May Affect Clinical Decision
An observational study of Sleep Apnea and Alveolar Hypoventilation, run by University Hospital, Geneva at 1 site in Switzerland.
Trial summary
In clinical practice discrepancies between overnight SpO2 recordings performed by 2 devices used simultaneously are regularly observed. However, this has not been systematically studied or quantified. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sleep Apnea, Alveolar Hypoventilation, Nocturnal Hypoxemia
- What is being tested?
- Simultaneous recording of nocturnal SpO2
- Type of treatment
- Medical device
- How many people
- 50 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jul 2023to 30 Oct 2023
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants will be recruited among 1) hospitalized patients with NIV treatment; 2) ambulatory patients followed for NIV therapy at the outpatient unit of the Division of Pulmonology; 3) patients undergoing an elective polysomnography (sleep study) for adjustment or titration of a positive pressure device (NIV or CPAP) at the Sleep Laboratory of the Division of Pulmonology.
Who may be able to join
- > 18 years old
- Awake room air SpO2 between 90 and 94%
- NIV or CPAP therapy
- Ambulatory or hospitalized patient in a clinically stable respiratory condition without any vasopressor treatment.
Who cannot join
- Hospitalization in an acute care setting (e.g. emergency room, Intensive Care Unit, Intermediate Care Unit)
- Any vasopressor treatment
- Peripheral vascular pathologies that can affect digital perfusion (e.g. history of ischemia, Raynaud's phenomenon, any type of vasculitis).
- Mechanical obstacles that may limit quality of signal (e.g. nail polish, bandage, splint, plaster).
- Patient already treated by long term nocturnal oxygen therapy (LTOT)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: How Differences in Oximeter Performance May Affect Clinical Decision: A Pragmatic Clinical Trial in Patients Under CPAP or Noninvasive Ventilation
In clinical practice discrepancies between overnight SpO2 recordings performed by 2 devices used simultaneously are regularly observed. However, this has not been systematically studied or quantified. It is therefore important to determine if these discrepancies are anecdotic, or frequent, and to what extent this may affect decisions in clinical practice such as implementing (or withdrawing) oxygen in subjects under noninvasive ventilation (NIV) or continuous positive airway pressure (CPAP), or adjusting NIV settings.
Read the detailed description
Pulse oximetry estimates oxygen saturation in the arterial blood by trans-illuminating a translucent tissue (usually a fingertip, or an ear lobe) with light-emitting diodes at 2 specific wavelengths. Absorption of light at these different wavelengths (660 nm, red, and 940 nm, infrared respectively) differs between oxygenated and deoxygenated hemoglobin. The amount of light which is transmitted at both wave lengths is then quantified and processed by an algorithm that displays a saturation value. The signals are corrected for the pulsatile nature of arterial oxygen flow. Devices also provide pulse rate measured by plethysmography (pulse-related changes in volume of fingertip or earlobe). Since its introduction in the early 1980s, pulse oximetry has proven to be an essential tool for the non-invasive assessment of blood oxygen saturation (SpO2). The use of pulse oximeter is now widespread and interests acute care settings as well as primary care settings. Although there have been recent improvements in signal analysis such as increasing sampling frequency and improving reflectance technology [4], the accuracy of commercially available oximeters differs. First of all, there is variability in the way accuracy of pulse oximetry devices is reported within 2% (± 1 SD) or within 5% (± 2 SD) of reference measurements obtained by blood gases analysis [5]. Secondly, there is a variability between commercially available devices, especially below a SpO2 of 90%. This is partly explained by the fact that calibration of the different algorithms employed in signal processing is limited by the range of saturations that can be safely obtained in healthy volunteers. In respiratory medicine, it has been shown that such variability of accuracy could affect the diagnosis of Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) and impact on clinical decisions as the recorded number of apneas/hypopneas varied between devices during nocturnal sleep studies [8] Nocturnal hypoxemia (NH) is considered as one of the major determinants of adverse cardiovascular complications and neurocognitive impairment in patients suffering of chronic respiratory failure (CRF). Because of its simplicity, short set-up time and short time response, pulse oximetry is a valuable screening tool for nocturnal hypoxemia despite its disadvantages such as motion artefacts or sensitivity to perfusion. Therefore, definitions of NH rely solely on nocturnal oximetry recording: for instance, in a consensus statement on noninvasive ventilation, spending > 5% of sleep time under 88% of SpO2 was considered as a relevant threshold. Definitions of NH remain arbitrary and different expert-based thresholds have been suggested in the medical literature [10]. Patients suffering from nocturnal hypoventilation, especially those with an average daytime SpO2 close to the steep portion of the hemoglobin dissociation curve (SpO2 between 90-94%), are at higher risk for NH. Therefore, in these patients, device imprecision could have a significant impact on medical decisions, such as deciding to adjust ventilator settings in patients under noninvasive ventilation (NIV) and/or implementing nocturnal oxygen supplementation.
In patients with CRF and NIV, after optimal adjustment of ventilator settings, prescription of nocturnal oxygen supplementation is common practice although impact of nocturnal oxygen supplementation on survival, patient comfort, or prevention of cor pulmonale has yet to be demonstrated. Practically speaking, it increases considerably the burden of the treatment for the patient and care givers (additional connections and tubings, noise of the oxygen concentrator etc.). To our knowledge, no study has evaluated how the use of different pulse oximeters could impact on this decision. Three types of devices are used in clinical practice: pulse oximetry using a probe connected to the home ventilator device, pulse oximetry combined with transcutaneous capnography, or using a "wrist watch" type of device.
- Conditions
- Sleep Apnea, Alveolar Hypoventilation, Nocturnal Hypoxemia
- Being tested
- Simultaneous recording of nocturnal SpO2
- Medical subject headings
- Sleep Apnea Syndromes, Hypoventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Simultaneous recording of nocturnal SpO2Device
The intervention will consist in performing a simultaneous recording of nocturnal SpO2 and pulse rate for at least 4 hours with 3 different devices.
What is being measured
The primary outcome is the main question the study is designed to answer.
Degree of agreement
The primary endpoint is the degree of agreement between 3 different devices used simultaneously for overnight SpO2 recording for 3 commonly used threshold values defining nocturnal hypoxemia: 5% of time with an SpO2 < 88%, 10% of time with an SpO2 < 90% or 20% of time with an SpO2 < 90%.
Measured: 3 months
Secondary outcomes (4)
Bland and Altman analysis of agreement
Bland and Altman analysis of agreement between devices , two by two (A vs B, A vs C)
Measured: 3 months
Degree of agreement with threshold values
an analysis of agreement of oxygen desaturation index between devices, comparing devices 2 x 2, and using a threshold value of 10/hour as clinically significant
Measured: 3 months
Minimal SpO2 value
a comparison of the minimal SpO2 value and time spent under different threshold levels (88 and 90%) between devices
Measured: 3 months
Mean pulse rate
A comparison of average pulse rate between devices
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2020
- Study start1 Jul 2023
- Primary completion30 Oct 2023
- Study completion30 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Sleep ApneaStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jean-Paul Janssens, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04474574
- Sponsor's protocol ID
- 2020-01813
- Status last verified
- Jan 2025
- First submitted
- 13 Jul 2020
- Last updated
- 22 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Karege G, Egger B, Lawi D, Bergeron A, Janssens JP. How Using Different Oximeters May Affect Clinical Decision-Making: A Method Comparison Study in Patients Receiving CPAP or Noninvasive Ventilation. Chest. 2026 Jan;169(1):244-256. doi: 10.1016/j.chest.2025.08.018. Epub 2025 Sep 9.
PubMed 40930342
Study at a glance
From the registry record, last updated by the sponsor on 22 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- How Differences in Oximeter Performance May Affect Clinical Decision: A Pragmatic Clinical Trial in Patients Under CPAP or Noninvasive Ventilation
- ClinicalTrials.gov ID
- NCT04474574
- Acronym / sponsor ID
- 2020-01813
- Conditions
- Sleep Apnea, Alveolar Hypoventilation, Nocturnal Hypoxemia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 30 Oct 2023 (actual)
- Study completion
- 30 Oct 2023 (actual)
- First posted
- 17 Jul 2020 (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.
In clinical practice discrepancies between overnight SpO2 recordings performed by 2 devices used simultaneously are regularly observed. However, this has not been systematically studied or quantified. It is therefore important to determine if these discrepancies are anecdotic, or frequent, and to what extent this may affect decisions in clinical practice such as implementing (or withdrawing) oxygen in subjects under noninvasive ventilation (NIV) or continuous positive airway pressure (CPAP), or adjusting NIV settings.
Detailed description
Pulse oximetry estimates oxygen saturation in the arterial blood by trans-illuminating a translucent tissue (usually a fingertip, or an ear lobe) with light-emitting diodes at 2 specific wavelengths. Absorption of light at these different wavelengths (660 nm, red, and 940 nm, infrared respectively) differs between oxygenated and deoxygenated hemoglobin. The amount of light which is transmitted at both wave lengths is then quantified and processed by an algorithm that displays a saturation value. The signals are corrected for the pulsatile nature of arterial oxygen flow. Devices also provide pulse rate measured by plethysmography (pulse-related changes in volume of fingertip or earlobe). Since its introduction in the early 1980s, pulse oximetry has proven to be an essential tool for the non-invasive assessment of blood oxygen saturation (SpO2). The use of pulse oximeter is now widespread and interests acute care settings as well as primary care settings. Although there have been recent improvements in signal analysis such as increasing sampling frequency and improving reflectance technology [4], the accuracy of commercially available oximeters differs. First of all, there is variability in the way accuracy of pulse oximetry devices is reported within 2% (± 1 SD) or within 5% (± 2 SD) of reference measurements obtained by blood gases analysis [5]. Secondly, there is a variability between commercially available devices, especially below a SpO2 of 90%. This is partly explained by the fact that calibration of the different algorithms employed in signal processing is limited by the range of saturations that can be safely obtained in healthy volunteers. In respiratory medicine, it has been shown that such variability of accuracy could affect the diagnosis of Obstructive Sleep Apnea Hypopnea Syndrome (OSAHS) and impact on clinical decisions as the recorded number of apneas/hypopneas varied between devices during nocturnal sleep studies [8] Nocturnal hypoxemia (NH) is considered as one of the major determinants of adverse cardiovascular complications and neurocognitive impairment in patients suffering of chronic respiratory failure (CRF). Because of its simplicity, short set-up time and short time response, pulse oximetry is a valuable screening tool for nocturnal hypoxemia despite its disadvantages such as motion artefacts or sensitivity to perfusion. Therefore, definitions of NH rely solely on nocturnal oximetry recording: for instance, in a consensus statement on noninvasive ventilation, spending > 5% of sleep time under 88% of SpO2 was considered as a relevant threshold. Definitions of NH remain arbitrary and different expert-based thresholds have been suggested in the medical literature [10]. Patients suffering from nocturnal hypoventilation, especially those with an average daytime SpO2 close to the steep portion of the hemoglobin dissociation curve (SpO2 between 90-94%), are at higher risk for NH. Therefore, in these patients, device imprecision could have a significant impact on medical decisions, such as deciding to adjust ventilator settings in patients under noninvasive ventilation (NIV) and/or implementing nocturnal oxygen supplementation.
In patients with CRF and NIV, after optimal adjustment of ventilator settings, prescription of nocturnal oxygen supplementation is common practice although impact of nocturnal oxygen supplementation on survival, patient comfort, or prevention of cor pulmonale has yet to be demonstrated. Practically speaking, it increases considerably the burden of the treatment for the patient and care givers (additional connections and tubings, noise of the oxygen concentrator etc.). To our knowledge, no study has evaluated how the use of different pulse oximeters could impact on this decision. Three types of devices are used in clinical practice: pulse oximetry using a probe connected to the home ventilator device, pulse oximetry combined with transcutaneous capnography, or using a "wrist watch" type of device.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants will be recruited among 1) hospitalized patients with NIV treatment; 2) ambulatory patients followed for NIV therapy at the outpatient unit of the Division of Pulmonology; 3) patients undergoing an elective polysomnography (sleep study) for adjustment or titration of a positive pressure device (NIV or CPAP) at the Sleep Laboratory of the Division of Pulmonology.
Key inclusion criteria (4 listed)
Key exclusion criteria (5 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Simultaneous recording of nocturnal SpO2The intervention will consist in performing a simultaneous recording of nocturnal SpO2 and pulse rate for at least 4 hours with 3 different devices. | Device | – |
Primary outcome
Degree of agreement
Time frame: 3 months
The primary endpoint is the degree of agreement between 3 different devices used simultaneously for overnight SpO2 recording for 3 commonly used threshold values defining nocturnal hypoxemia: 5% of time with an SpO2 < 88%, 10% of time with an SpO2 < 90% or 20% of time with an SpO2 < 90%.
4 secondary outcomes
Bland and Altman analysis of agreement
Time frame: 3 months
Degree of agreement with threshold values
Time frame: 3 months
Minimal SpO2 value
Time frame: 3 months
Mean pulse rate
Time frame: 3 months
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 22 Jan 2025.
- Derived from this study: PubMed 40930342Karege G, Egger B, Lawi D, Bergeron A, Janssens JP. How Using Different Oximeters May Affect Clinical Decision-Making: A Method Comparison Study in Patients Receiving CPAP or Noninvasive Ventilation. Chest. 2026 Jan;169(1):244-256. doi: 10.1016/j.chest.2025.08.018. Epub 2025 Sep 9.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sleep Apnea and Alveolar Hypoventilation, run by University Hospital, Geneva at 1 site in Switzerland.
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 4 inclusion and 5 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 22 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Degree of agreement (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04474574, which also lists 1 linked publication.
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 22 Jan 2025.