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)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Ligue Pulmonaire Genevoise
- Enrollment
- 56
- Locations
- 1
- Primary Endpoint
- Limits of agreement between devices for oxygen saturation (SpO2) at the end of a six-minute walk test.
Study Overview
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.
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).
Study Design
- Study Type
- Observational
- Observational Model
- Other
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- 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)