Pulmonary RehabilitationNCT07742865
Agreement Between 5 Different Pulse Oximeters Used Simultaneously During a Six-minute Walk Test
An observational study of Pulmonary Rehabilitation and Six Minute Walk Test, run by Ligue Pulmonaire Genevoise at 1 site in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pulmonary Rehabilitation, Six Minute Walk Test
- How many people
- 56 participants
- Where
- 1 siteSwitzerland
- Study dates
- 1 Jun 2025to 31 Mar 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to an outpatient pulmonary rehabilitation program
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pulmonary Rehabilitation, Six Minute Walk Test
- Keywords
- pulse oximetry, six-minute walk test, pulmonary rehabilitation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Study group | All patients undergo the same simultaneous measurement of oxygen saturation with 5 different devices. No randomisation, no sham device. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Same analysis as primary outcome
Measured: 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)
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2026
- Study start1 Jun 2025
- Primary completion31 Mar 2026
- Study completion31 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary RehabilitationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ligue Pulmonaire Genevoise
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07742865
- Sponsor's protocol ID
- 2024-02489
- Status last verified
- Jul 2026
- First submitted
- 1 Sep 2025
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07742865
- Acronym / sponsor ID
- 2024-02489
- Conditions
- Pulmonary Rehabilitation, Six Minute Walk Test
- Keywords
- pulse oximetry, six-minute walk test, pulmonary rehabilitation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- Ligue Pulmonaire GenevoiseUniversity, hospital or other
- Study start
- 1 Jun 2025 (actual)
- Primary completion
- 31 Mar 2026 (actual)
- Study completion
- 31 Mar 2026 (actual)
- First posted
- 3 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Study group | – | –All patients undergo the same simultaneous measurement of oxygen saturation with 5 different devices. No randomisation, no sham device. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to an outpatient pulmonary rehabilitation program
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Limits of agreement between devices for oxygen saturation (SpO2) at the end of a six-minute walk test.
Time frame: Baseline
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.
2 secondary outcomes
Limits of agreement between devices for heart rate at T0 (start of test), T6 (end of test) and maximal and minimal values
Time frame: Baseline
Agreement between devices for identifying subjects who have a significant drop in SpO2 (desaturate) during the six-minute walk test
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: No
Related trials for Pulmonary Rehabilitation
Recruiting
Rehabilitation in Safety-net Environments (RISE) to Improve Outcomes in Vulnerable Patients With COPD
COPD (Chronic Obstructive Pulmonary Disease)
Not yet recruiting
Effects of Tele-rehabilitation-Guided Qigong on Children and Adolescents With Asthma
Asthma Childhood
RecruitingObservational study
Changes in Energy Expenditure in Response to Physical Activity in Healthy Adults
Physical Activities
Not yet recruiting
Effects of Respiratory Muscle Strength Training in Children With Asthma
Asthma (Diagnosis)
Active, not recruiting
Inspiratory Muscle Training Immediately After Lung Transplantation
Lung Transplantation, Chronic Lung Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pulmonary Rehabilitation and Six Minute Walk Test, run by Ligue Pulmonaire Genevoise at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Limits of agreement between devices for oxygen saturation (SpO2) at the end of a six-minute walk test. (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026.