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Finger Versus Earlobe Pulse Oximetry During the 6-Minute Walk Test in Interstitial Lung Disease (OXISITE-ILD)

21. Juli 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Geschätzt)

100

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

  • Name: Jaume Bordas-Martinez, Ph.D.; M.D.
  • Telefonnummer: 938 42 50 00
  • E-Mail: jbordas@fphag.org

Studienorte

  • Spanien
    • Spain
      • Granollers, Spain, Spanien, 08402
        • Rekrutierung
        • Hospital de Granollers

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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.

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Intervention / Behandlung
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.
Sonstiges: Dual-site pulse oximetry (finger and earlobe)
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.

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Intraclass correlation coefficient for agreement in minimum SpO2 between sensor locations
Zeitfenster: Day 1
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.
Day 1
Bland-Altman agreement in minimum SpO2 between sensor locations
Zeitfenster: Day 1
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.
Day 1

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Reclassification of exertional desaturation between sensor locations at SpO2 below 88%
Zeitfenster: Day 1
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.
Day 1
Reclassification of exertional desaturation between sensor locations at SpO2 below 90%
Zeitfenster: Day 1
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.
Day 1
Reclassification of exertional desaturation between sensor locations at a fall in SpO2 of 4% or more
Zeitfenster: Day 1
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.
Day 1
Agreement in minimum SpO2 by autoimmune versus non-autoimmune ILD
Zeitfenster: Day 1
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).
Day 1
Rate of invalid or poor-quality readings by sensor location
Zeitfenster: Day 1
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.
Day 1
Clinical, vascular and functional predictors of discordance
Zeitfenster: Day 1
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.
Day 1

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Agreement in SpO2 at additional timepoints
Zeitfenster: Day 1
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.
Day 1
Quantitative paired difference and Passing-Bablok regression between sensor locations
Zeitfenster: Day 1
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.
Day 1
Agreement of each sensor location with baseline arterial oxygen saturation
Zeitfenster: Day 1
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.
Day 1
Direct and indirect cost associated with invalid finger readings
Zeitfenster: Day 1
Exploratory description of the direct and indirect costs associated with invalid or poor-quality finger readings. No prespecified cost model is applied.
Day 1

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Hospital de Granollers

Ermittler

  • Studienleiter: Jaume Bordas-Martinez, M.D., Ph.D., Hospital de Granollers

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

13. Januar 2026

Primärer Abschluss (Geschätzt)

1. August 2027

Studienabschluss (Geschätzt)

31. Dezember 2027

Studienanmeldedaten

Zuerst eingereicht

30. Juni 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

21. Juli 2026

Zuerst gepostet (Tatsächlich)

23. Juli 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

23. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

21. Juli 2026

Zuletzt verifiziert

1. Juli 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • OXISITE-ILD

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

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