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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)

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Spain
Hospital de Granollers
RECRUITING
Granollers
Contact Information
Primary
Jaume Bordas-Martinez, Ph.D.; M.D.
jbordas@fphag.org
938 42 50 00
Time Frame
Start Date: 2026-01-13
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 100
Treatments
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.
Sponsors
Leads: Hospital de Granollers

This content was sourced from clinicaltrials.gov