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

Agreement Between 5 Different Pulse Oximeters Used Simultaneously During a Six-minute Walk Test (Concordance Entre Pulse oxymètres Lors d'un Test de Marche standardisé de 6 Minutes)

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.

Study Overview

• Status: Completed
• Conditions: Pulmonary Rehabilitation; Six Minute Walk Test

Detailed Description

51 patients will be included in this study , corresponding to an inclusion period of approximately 3 months.

Patients are all referred for an outpatient pulmonary rehabilitation program for which one or several six-minute walk test (6MWT) is standard procedure.

After the patient has given his/her consent and signed the consent form, they will be fitted with various pulse oximeter sensors (all CE certified and Bluetooth enabled):

• An ear sensor connected to the Nonin Wrist OX2 3150 pulse oximeter
• A flexible digital sensor connected to a Nonin Wrist OX2 3150 pulse oximeter
• A MightySat Rx digital pulse oximeter
• A rigid digital sensor connected to the Masimo Rad-G pulse oximeter
• A Nonin Vantage 9590 digital pulse oximeter from Onyx

The pulse oximeters are placed on the fingers of one hand (chosen according to patient comfort) and a lightweight shoulder strap is used to hold the arm against the abdomen in order to minimise any movement artefacts caused by arm swinging during walking. One of the oximeters is connected to a sensor placed on the earlobe . The last oximeter (Nonin Vantage 9590 from Onyx) is not equipped with Bluetooth transmission and cannot calculate the average or minimum SpO2. However, it is representative of the pulse oximeters commonly acquired and used by patients and caregivers. We will therefore record the results it gives at T0, T6, and at the end of the observation (it will be placed on the free hand).

The patient then receives standardised information about the six-minute walk test procedure (6MWT). The nurse or physiotherapist measures the patient's vital signs at rest: HR, BP, SpO2, dyspnoea on a modified Borg scale.

The 6MWT is then performed for 6 minutes in a marked 30-metre corridor, with standardised information provided every minute until the end of the test, in accordance with international recommendations. The patient is asked to walk at a pace that they think they can maintain for 6 minutes. If they experience excessive dyspnoea, they may sit down and resume the test as soon as they feel able to do so. The test is interrupted if SpO2 falls below 80% (on any of the pulse oximeters). Perceived breathlessness is recorded every minute. SpO2 and HR results are transmitted via Bluetooth to a tablet and can be monitored 'live'.

At the end of the test, the patient sits down and their vital signs are measured for another 2 minutes.

The data obtained during the test is then coded and transferred to an electronic case report form (eCRF) with a numerical code that does not refer to the patient's date of birth or initials.

A list of cases and their codes is kept in a password-protected Excel file, stored by a person outside the study staff.

Inclusion in the protocol takes place at most once per patient.

• Study Type: Observational
• Enrollment (Actual): 56

Contacts and Locations

Study Locations

• Switzerland
  • Canton of Geneva
    • Meyrin, Canton of Geneva, Switzerland, 1217
      • Hôpital de La Tour

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients admitted to an outpatient pulmonary rehabilitation program

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Study group; All patients undergo the same simultaneous measurement of oxygen saturation with 5 different devices. No randomisation, no sham device.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Limits of agreement between devices for heart rate at T0 (start of test), T6 (end of test) and maximal and minimal values	Same analysis as primary outcome	Baseline
Agreement between devices for identifying subjects who have a significant drop in SpO2 (desaturate) during the six-minute walk test	Subjects will be identified as desaturating or not according to 5 pre-defined criteria (minimal SpO2 < or = 90%, < or = 88%; mean SpO2 < or = 90%, < or = 88%; presence or absence of a drop in SpO2 > or = 4% between T0 and minimal value recorded)	Baseline

Collaborators and Investigators

• Sponsor: Ligue Pulmonaire Genevoise

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2025
• Primary Completion (Actual): March 31, 2026
• Study Completion (Actual): March 31, 2026

Study Registration Dates

• First Submitted: September 1, 2025
• First Submitted That Met QC Criteria: July 30, 2026
• First Posted (Actual): August 3, 2026

Study Record Updates

• Last Update Posted (Actual): August 3, 2026
• Last Update Submitted That Met QC Criteria: July 30, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: pulmonary rehabilitation; pulse oximetry; six-minute walk test
• Other Study ID Numbers: 2024-02489

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No