Interstitial Lung Disease (ILD)OXISITE-ILDNCT07723872
Finger Versus Earlobe Pulse Oximetry During the 6-Minute Walk Test in Interstitial Lung Disease
An observational study of Interstitial Lung Disease (ILD) and Idiopathic Pulmonary Fibrosis (IPF), run by Hospital de Granollers at 1 site in Spain.
Trial summary
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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Interstitial Lung Disease (ILD), Idiopathic Pulmonary Fibrosis (IPF), Progressive Pulmonary Fibrosis
- What is being tested?
- Dual-site pulse oximetry (finger and earlobe)
- How many people
- 100 participants
- Where
- 1 siteSpain
- Study dates
- 13 Jan 2026to 31 Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: 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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Spain1 site, 1 recruiting
- Recruiting
Hospital de Granollers
Granollers, Spain, 08402
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Interstitial Lung Disease (ILD), Idiopathic Pulmonary Fibrosis (IPF), Progressive Pulmonary Fibrosis, Connective Tissue Disease-Associated Interstitial Lung Disease, Interstitial Lung Disease Due to Connective Tissue Disease (Disorder)
- Being tested
- Dual-site pulse oximetry (finger and earlobe)
- Keywords
- Pulse Oximetry, Earlobe Oximetry, Finger Oximetry, Oxygen Saturation, SpO2, Six-Minute Walk Test, Exercise Desaturation, Ambulatory Oxygen, Interstitial Lung Disease, Idiopathic Pulmonary Fibrosis, Connective Tissue Disease-ILD, Systemic Sclerosis, Method Comparison, Bland-Altman Analysis
- Medical subject headings
- Lung Diseases, Interstitial, Idiopathic Pulmonary Fibrosis, Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dual-site pulse oximetry (finger and earlobe)Other
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Dual-site pulse oximetry (finger and earlobe) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraclass correlation coefficient for agreement in minimum SpO2 between sensor locations
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.
Measured: Day 1
Bland-Altman agreement in minimum SpO2 between sensor locations
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.
Measured: Day 1
Secondary outcomes (6)
Reclassification of exertional desaturation between sensor locations at SpO2 below 88%
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.
Measured: Day 1
Reclassification of exertional desaturation between sensor locations at SpO2 below 90%
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.
Measured: Day 1
Reclassification of exertional desaturation between sensor locations at a fall in SpO2 of 4% or more
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.
Measured: Day 1
Agreement in minimum SpO2 by autoimmune versus non-autoimmune ILD
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).
Measured: Day 1
Rate of invalid or poor-quality readings by sensor location
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.
Measured: Day 1
Clinical, vascular and functional predictors of discordance
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start13 Jan 2026
- Primary completion1 Aug 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Interstitial Lung Disease (ILD)Studies 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
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Granollers
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jaume Bordas-Martinez, Hospital de Granollers
- Investigators
- Jaume Bordas-Martinez, M.D., Ph.D., Study director, Hospital de Granollers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07723872
- Sponsor's protocol ID
- OXISITE-ILD
- Acronym
- OXISITE-ILD
- Status last verified
- Jul 2026
- First submitted
- 30 Jun 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07723872
- Acronym / sponsor ID
- OXISITE-ILD / OXISITE-ILD
- Conditions
- Interstitial Lung Disease (ILD), Idiopathic Pulmonary Fibrosis (IPF), Progressive Pulmonary Fibrosis, Connective Tissue Disease-Associated Interstitial Lung Disease, Interstitial Lung Disease Due to Connective Tissue Disease (Disorder)
- Keywords
- Pulse Oximetry, Earlobe Oximetry, Finger Oximetry, Oxygen Saturation, SpO2, Six-Minute Walk Test, Exercise Desaturation, Ambulatory Oxygen
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Hospital de GranollersUniversity, hospital or other
- Study start
- 13 Jan 2026 (actual)
- Primary completion
- 1 Aug 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 23 Jul 2026 (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.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ILD patients undergoing the 6MWT | – | Other: Dual-site pulse oximetry (finger and earlobe)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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
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 |
|---|---|---|
| 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. | Other | ILD patients undergoing the 6MWT |
Primary outcome
Intraclass correlation coefficient for agreement in minimum SpO2 between sensor locations
Time frame: 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.
Bland-Altman agreement in minimum SpO2 between sensor locations
Time frame: 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.
6 secondary outcomes
Reclassification of exertional desaturation between sensor locations at SpO2 below 88%
Time frame: Day 1
Reclassification of exertional desaturation between sensor locations at SpO2 below 90%
Time frame: Day 1
Reclassification of exertional desaturation between sensor locations at a fall in SpO2 of 4% or more
Time frame: Day 1
Agreement in minimum SpO2 by autoimmune versus non-autoimmune ILD
Time frame: Day 1
Rate of invalid or poor-quality readings by sensor location
Time frame: Day 1
Clinical, vascular and functional predictors of discordance
Time frame: Day 1
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2026.
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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.
Jaume Bordas-Martinez, M.D., Ph.D. study director
Hospital de Granollers
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 Interstitial Lung Disease (ILD) and Idiopathic Pulmonary Fibrosis (IPF), run by Hospital de Granollers at 1 site in Spain.
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 5 inclusion and 2 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: looking for participants now, as of the sponsor's last update on 23 Jul 2026. 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 Spain. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jaume Bordas-Martinez, Ph.D.; M.D. (938 42 50 00, jbordas@fphag.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Intraclass correlation coefficient for agreement in minimum SpO2 between sensor locations (time frame: Day 1). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Jul 2026.