Finger Versus Earlobe Pulse Oximetry During the 6-Minute Walk Test in Interstitial Lung Disease (OXISITE-ILD)
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.
調査の概要
状態
条件
詳細な説明
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.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Jaume Bordas-Martinez, Ph.D.; M.D.
- 電話番号：938 42 50 00
- メール：jbordas@fphag.org
研究場所
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Spain
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Granollers、Spain、スペイン、08402
- 募集
- Hospital de Granollers
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Intraclass correlation coefficient for agreement in minimum SpO2 between sensor locations
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Reclassification of exertional desaturation between sensor locations at SpO2 below 88%
時間枠：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%
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Agreement in SpO2 at additional timepoints
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
スポンサー
捜査官
- スタディディレクター：Jaume Bordas-Martinez, M.D., Ph.D.、Hospital de Granollers
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
キーワード
その他の研究ID番号
- OXISITE-ILD
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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