MedTrace Logo

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

NCT07723872 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2026-07-23

No results posted yet for this study

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). 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.

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)

Interventions

OTHER

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.

Sponsors & Collaborators

  • Hospital de Granollers

    lead OTHER

Principal Investigators

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

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-13
Primary Completion
2027-08-01
Completion
2027-12-31

Countries

  • Spain

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07723872 on ClinicalTrials.gov