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)
Descripción general del estudio
Estado
Descripción detallada
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.
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Canton of Geneva
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Meyrin, Canton of Geneva, Suiza, 1217
- Hôpital de La Tour
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Método de muestreo
Población de estudio
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Study group
All patients undergo the same simultaneous measurement of oxygen saturation with 5 different devices.
No randomisation, no sham device.
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Limits of agreement between devices for oxygen saturation (SpO2) at the end of a six-minute walk test.
Periodo de tiempo: Baseline
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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.
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Baseline
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Limits of agreement between devices for heart rate at T0 (start of test), T6 (end of test) and maximal and minimal values
Periodo de tiempo: Baseline
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Same analysis as primary outcome
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Baseline
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Agreement between devices for identifying subjects who have a significant drop in SpO2 (desaturate) during the six-minute walk test
Periodo de tiempo: Baseline
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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)
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Baseline
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Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Otros números de identificación del estudio
- 2024-02489
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
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