Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
RECRUITING
NCT07723872

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

Sponsor: Hospital de Granollers

View on ClinicalTrials.gov

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.

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)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

OBSERVATIONAL

Enrollment

100

Start Date

2026-01-13

Completion Date

2027-12-31

Last Updated

2026-07-23

Healthy Volunteers

No

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.

Locations (1)

Hospital de Granollers

Granollers, Spain, Spain