An observational study in Sleep Apnea, Alveolar Hypoventilation and Nocturnal Hypoxemia, sponsored by University Hospital, Geneva. Completed at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-01-22.
Sponsored by University Hospital, Geneva · Observational
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.
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.
1,084 studies on the registry are indexed under Sleep Apnea Syndromes; 171 are open to participants now.
This study's enrollment of 50 is below the median of 150 across 343 observational studies indexed under Sleep Apnea Syndromes.
Browse Sleep Apnea Syndromes studies →University Hospital, Geneva is the lead sponsor of 379 studies on the registry; 70 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
> 18 years old
Hospitalization in an acute care setting (e.g. emergency room, Intensive Care Unit, Intermediate Care Unit)
The intervention will consist in performing a simultaneous recording of nocturnal SpO2 and pulse rate for at least 4 hours with 3 different devices.
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%.
Time frame: 3 months
Bland and Altman analysis of agreement
Bland and Altman analysis of agreement between devices , two by two (A vs B, A vs C)
Time frame: 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
Time frame: 3 months
Minimal SpO2 value
a comparison of the minimal SpO2 value and time spent under different threshold levels (88 and 90%) between devices
Time frame: 3 months
Mean pulse rate
A comparison of average pulse rate between devices
Time frame: 3 months
Plan to share: Undecided
No publications or documents are linked to this record.
This study is completed, as verified in Jan 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.