Agreement Between 5 Different Pulse Oximeters Used Simultaneously During a Six-minute Walk Test

NCT07742865 | Completed

• 1 other identifier: 2024-02489
• Study Type: observational
• Target: 56
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare the results obtained during a standardised 6-minute walk test with five different pulse oximeters, in adults admitted to an outpatient pulmonary rehabilitation program, to determine the agreement between devices of current use for measuring oxygen saturation (SpO2) and identifying subjects with desaturation during the test.

Conditions

Pulmonary Rehabilitation; Six Minute Walk Test

Keywords

pulse oximetry; six-minute walk test; pulmonary rehabilitation

Outcome Measures

Primary Outcomes (1)

• Limits of agreement between devices for oxygen saturation (SpO2) at the end of a six-minute walk test.

  An analysis according to the Bland and Altman method comparing devices by pairs allows to determine the bias (mean error) and the limits of agreement for the SpO2 measured at the end of the walk test.

  Baseline

Secondary Outcomes (2)

• Limits of agreement between devices for heart rate at T0 (start of test), T6 (end of test) and maximal and minimal values

  Baseline

• Agreement between devices for identifying subjects who have a significant drop in SpO2 (desaturate) during the six-minute walk test

  Baseline

Study Arms (1)

Study group

All patients undergo the same simultaneous measurement of oxygen saturation with 5 different devices. No randomisation, no sham device.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to an outpatient pulmonary rehabilitation program

You may qualify if:

• All patients referred to our Cardiorespiratory Unit for a pulmonary rehabilitation programme
• Aged over 18, no maximum age limit
• Absence of language barriers or cognitive impairments that would make it impossible to explain the protocol
• Resting SpO2 \> 90%
• Signing the informed consent form after receiving detailed information about the study.

You may not qualify if:

• Any clinical condition that makes it impossible or compromises the performance of a walking test: unstable heart disease, acute myocarditis and/or pericarditis, acute arrhythmia, severe pulmonary hypertension, deep vein thrombosis, severe asthma, acute orthopaedic or rheumatic condition
• Unstable clinical condition (patient hospitalised or less than 4 weeks after an exacerbation leading to hospitalisation)
• Oxygen therapy at rest and/or during walking
• Uncontrolled arterial hypertension (AHT) at rest
• Known cardiac rhythm disorder
• Unexplained chest pain at rest
• Mechanical interference with the possibility of placing pulse oximeters: skin lesions, bandages, plaster casts, etc.
• Withdrawal of consent during the study
• Systemic scleroderma, sclerodactyly, history of any type of vasculitis
• Symptomatic Raynaud's phenomenon
• Marked clubbing
• Known haemoglobinopathy
• Refusal to remove nail polish

Sponsors & Collaborators

• Ligue Pulmonaire Genevoise: lead

Study Sites (1)

Hôpital de La Tour

Meyrin, Canton of Geneva, 1217, Switzerland

Location

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 1, 2025
• First Posted: August 3, 2026
• Study Start: June 1, 2025
• Primary Completion: March 31, 2026
• Study Completion: March 31, 2026
• Last Updated: August 3, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)