Finger Versus Earlobe Pulse Oximetry During the 6-Minute Walk Test in Interstitial Lung Disease (OXISITE-ILD)
21 luglio 2026 aggiornato da: Jaume Bordas-Martinez, Hospital de Granollers
A Prospective, Multicenter, Observational Method-Comparison Study of Finger Versus Earlobe Pulse Oximetry for Oxygen Saturation During the Six-Minute Walk Test in Patients With Interstitial Lung Disease (OXISITE-ILD)
The OXISITE-ILD study is a prospective, multicenter, observational study designed to evaluate the agreement between finger (digital) and earlobe (auricular) pulse oximetry for measuring oxygen saturation (SpO2) during the six-minute walk test (6MWT) in patients with interstitial lung disease (ILD). In routine clinical practice, exercise SpO2 is usually measured at the finger; however, the finger reading can be unreliable in some patients, and there is currently no recommendation on the best sensor location in ILD. This study compares the two sensor locations, recorded at the same time, and evaluates whether any disagreement changes how exercise desaturation is classified and whether ambulatory oxygen is indicated.
All patients undergoing a 6MWT as part of routine ILD care are included consecutively to ensure a pragmatic, real-world representation of the ILD population. The primary objective is to measure the agreement between the two locations in the lowest SpO2 reached during the test, including the size and direction of any difference. Secondary objectives include the reclassification of patients at the clinical desaturation thresholds, the comparison between autoimmune and non-autoimmune ILD, the rate of invalid readings at each location, and the clinical, vascular and functional factors associated with disagreement.
Panoramica dello studio
Stato
Reclutamento
Condizioni
Intervento / Trattamento
Descrizione dettagliata
OXISITE-ILD is a prospective, consecutive, multicenter, observational, cross-sectional method-comparison (agreement) study.
Each participant is assessed once, during a single 6MWT performed as part of routine care. SpO2 and heart rate are recorded simultaneously at the finger and at the earlobe with two pulse oximeters, at eight timepoints: baseline, each of minutes 1 to 6, and after a 2-minute recovery. The paired heart rate at each timepoint is used as a signal-quality control, so that agreement is assessed only on simultaneous, valid readings. In some participants, an arterial blood gas or a nailfold capillaroscopy may also be performed to help interpret the difference between locations.
A minimum of 100 participants is planned at the coordinating center, sufficient on its own for the primary objective; recruitment may be extended at the coordinating center and at the collaborating centers as the study requires. The participation of collaborating centers is opportunistic and adds precision, subgroup analyses, and external validity.
Tipo di studio
Osservativo
Iscrizione (Stimato)
100
Contatti e Sedi
Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.
Contatto studio
- Nome: Jaume Bordas-Martinez, Ph.D.; M.D.
- Numero di telefono: 938 42 50 00
- Email: jbordas@fphag.org
Luoghi di studio
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Spain
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Granollers, Spain, Spagna, 08402
- Reclutamento
- Hospital de Granollers
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Criteri di partecipazione
I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.
Criteri di ammissibilità
Età idonea allo studio
- Adulto
- Adulto più anziano
Accetta volontari sani
No
Metodo di campionamento
Campione non probabilistico
Popolazione di studio
Consecutive adults with a confirmed diagnosis of interstitial lung disease (ILD), either newly diagnosed or under follow-up, attending the ILD/pulmonary fibrosis units of the participating centres and undergoing a clinically indicated 6-minute walk test.
Patients with or without prior oxygen therapy are enrolled consecutively, and baseline oxygen status (none, exertional only, or at rest) is recorded.
Each patient is assessed on a single occasion, consistent with the cross-sectional design.
Descrizione
Inclusion Criteria:
- Adults aged 18 years or older
- Confirmed diagnosis of interstitial lung disease (ILD) based on clinical, radiological and/or histological criteria
- Newly diagnosed or under follow-up for ILD
- Physically and cognitively able to perform the 6-minute walk test (6MWT)
- Signed informed consent
Exclusion Criteria:
- Inability to obtain a reliable, stable baseline pulse oximetry reading at the finger and/or the earlobe, preventing a valid paired baseline measurement and the calculation of agreement
- ILD exacerbation, decompensated comorbidity, or acute respiratory infection at the time of the test
Piano di studio
Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.
Come è strutturato lo studio?
Dettagli di progettazione
Coorti e interventi
Gruppo / Coorte |
Intervento / Trattamento |
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ILD patients undergoing the 6MWT
Adults with an established diagnosis of interstitial lung disease (ILD) undergoing a six-minute walk test (6MWT) as part of routine care.
Each participant is assessed once, with oxygen saturation (SpO2) and heart rate recorded simultaneously at the finger and at the earlobe.
Pre-specified subgroups for the analysis are autoimmune-associated versus non-autoimmune ILD.
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During a single 6MWT, SpO2 and heart rate are recorded simultaneously at the finger (digital) and the earlobe (auricular) with two pulse oximeters, at eight timepoints (baseline, minutes 1 to 6, and a 2-minute recovery).
No treatment is administered and routine clinical management is not modified; the procedure adds the simultaneous earlobe measurement for comparison with the finger.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Intraclass correlation coefficient for agreement in minimum SpO2 between sensor locations
Lasso di tempo: Day 1
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Absolute agreement in minimum SpO2 during the six-minute walk test between the finger and earlobe sensors, quantified with the intraclass correlation coefficient (two-way mixed-effects model, absolute agreement) and its 95% confidence interval.
ICC values are interpreted as below 0.50 poor, 0.50 to 0.75 moderate, 0.75 to 0.90 good, and above 0.90 excellent agreement.
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Day 1
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Bland-Altman agreement in minimum SpO2 between sensor locations
Lasso di tempo: Day 1
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Agreement in minimum SpO2 during the six-minute walk test between the finger and earlobe sensors, assessed with Bland-Altman analysis: mean bias (earlobe minus finger) with its 95% confidence interval and 95% limits of agreement, evaluated against a prespecified clinically acceptable difference of 3 percentage points.
The direction of the bias is reported, as the finger is hypothesised to register lower values than the earlobe.
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Day 1
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
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Reclassification of exertional desaturation between sensor locations at SpO2 below 88%
Lasso di tempo: Day 1
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Proportion of participants whose classification of significant exertional desaturation changes between the finger and earlobe sensors at the threshold of minimum SpO2 below 88% (American Thoracic Society indication threshold for ambulatory oxygen).
Agreement is assessed with the Cohen kappa coefficient (Landis-Koch interpretation) and the difference in proportions with the McNemar test for paired data.
At this threshold the McNemar test and the raw reclassification proportions are the primary read, as kappa can be unstable when prevalence is extreme.
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Day 1
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Reclassification of exertional desaturation between sensor locations at SpO2 below 90%
Lasso di tempo: Day 1
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Proportion of participants whose classification of significant exertional desaturation changes between the finger and earlobe sensors at the threshold of minimum SpO2 below 90% (British Thoracic Society indication threshold for ambulatory oxygen).
Agreement is assessed with the Cohen kappa coefficient (Landis-Koch interpretation) and the difference in proportions with the McNemar test for paired data.
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Day 1
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Reclassification of exertional desaturation between sensor locations at a fall in SpO2 of 4% or more
Lasso di tempo: Day 1
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Proportion of participants whose classification changes between the finger and earlobe sensors at the prognostic threshold of a fall in minimum SpO2 of 4% or more from baseline.
Agreement is assessed with the Cohen kappa coefficient (Landis-Koch interpretation) and the difference in proportions with the McNemar test for paired data.
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Day 1
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Agreement in minimum SpO2 by autoimmune versus non-autoimmune ILD
Lasso di tempo: Day 1
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Comparison of the agreement between sensor locations (intraclass correlation coefficient and Bland-Altman) in autoimmune-associated ILD versus non-autoimmune ILD, with interstitial pneumonia with autoimmune features (IPAF) described separately.
Where sample size permits, agreement is also described, exploratorily and without formal hypothesis testing, by major ILD subtype (for example idiopathic pulmonary fibrosis, hypersensitivity pneumonitis, or connective tissue disease-associated ILD), and by autoimmune subtype (for example systemic sclerosis or rheumatoid arthritis).
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Day 1
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Rate of invalid or poor-quality readings by sensor location
Lasso di tempo: Day 1
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Comparison, among enrolled participants, of the rate of invalid or poor-quality (low-signal) readings between the finger and earlobe sensors during the six-minute walk test, across the eight measurement timepoints.
At each timepoint the paired heart rate from the two sensors is used as a signal-quality control: a discordant heart rate flags poor signal or sensor disconnection and identifies invalid SpO2 readings, so that agreement is assessed only on simultaneous, valid readings.
The per-participant difference in the rate of invalid readings between sensor locations is reported with its 95% confidence interval and the McNemar test for paired data.
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Day 1
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Clinical, vascular and functional predictors of discordance
Lasso di tempo: Day 1
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Clinical, vascular and functional factors associated with discordance between sensor locations, including ILD type (autoimmune-associated versus other), autoimmune subtype (systemic sclerosis versus other), fibrosing versus non-fibrosing ILD, pathological capillaroscopy, Raynaud phenomenon, skin pigmentation, cardiovascular comorbidity, and pulmonary function (FVC and DLCO).
For each discordance criterion (SpO2 below 88%, SpO2 below 90%, and a fall of 4% or more) a logistic regression model is fitted with the patient as the unit of analysis, complemented by mixed-effects logistic regression (GLMM) with the measurement timepoint as a predictor and a random intercept per participant.
Missing data from incomplete follow-up are handled by maximum likelihood; penalised regression (L1/L2) is considered if events are sparse.
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Day 1
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Altre misure di risultato
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
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Agreement in SpO2 at additional timepoints
Lasso di tempo: Day 1
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Agreement between sensor locations in SpO2 at baseline, maximum, per-minute intervals during the walk, and recovery, assessed with the intraclass correlation coefficient and Bland-Altman analysis.
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Day 1
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Quantitative paired difference and Passing-Bablok regression between sensor locations
Lasso di tempo: Day 1
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Exploratory analysis of systematic differences between the finger and earlobe in SpO2.
The paired difference (earlobe minus finger) is summarised with its 95% confidence interval (paired t test, or Wilcoxon signed-rank test with a Hodges-Lehmann interval, as appropriate).
Passing-Bablok regression is used to detect constant and proportional differences between the two locations, with 95% confidence intervals for the intercept and the slope.
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Day 1
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Agreement of each sensor location with baseline arterial oxygen saturation
Lasso di tempo: Day 1
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Exploratory comparison of the agreement of finger and of earlobe SpO2 with baseline arterial oxygen saturation, in the subgroup of participants undergoing arterial blood gas sampling.
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Day 1
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Direct and indirect cost associated with invalid finger readings
Lasso di tempo: Day 1
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Exploratory description of the direct and indirect costs associated with invalid or poor-quality finger readings.
No prespecified cost model is applied.
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Day 1
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Collaboratori e investigatori
Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.
Sponsor
Investigatori
- Direttore dello studio: Jaume Bordas-Martinez, M.D., Ph.D., Hospital de Granollers
Studiare le date dei record
Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.
Studia le date principali
Inizio studio (Effettivo)
13 gennaio 2026
Completamento primario (Stimato)
1 agosto 2027
Completamento dello studio (Stimato)
31 dicembre 2027
Date di iscrizione allo studio
Primo inviato
30 giugno 2026
Primo inviato che soddisfa i criteri di controllo qualità
21 luglio 2026
Primo Inserito (Effettivo)
23 luglio 2026
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
23 luglio 2026
Ultimo aggiornamento inviato che soddisfa i criteri QC
21 luglio 2026
Ultimo verificato
1 luglio 2026
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
- Test del cammino di sei minuti
- Sclerosi sistemica
- Fibrosi Polmonare Idiopatica
- Pulsossimetria
- Malattia polmonare interstiziale
- SpO2
- Saturazione di ossigeno
- Confronto di metodi
- Ossigeno ambulatoriale
- Malattia del Tessuto Connettivo-ILD
- Earlobe Oximetry
- Finger Oximetry
- Exercise Desaturation
- Bland-Altman Analysis
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- OXISITE-ILD
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
No
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
No
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .