- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT05210881
Weaning From Nasal High Flow Therapy
26 de enero de 2022 actualizado por: Prof Jean-Damien RICARD, Hôpital Louis Mourier
Weaning From Nasal High Flow Therapy: an Explorative Study Assessing the Usefulness of the ROX Index to Predict Outcome of the Weaning Process in Combination With a Withdrawal Trial
Nasal high flow is widely used in critically ill patients admitted to the intensive care unit (ICU) for acute hypoxemic respiratory failure.
It has been shown to improve patient comfort, increase oxygenation and reduce need for intubation in some patients.
The Respiratory Oxygenation (ROX) index has been established as a simple tool to help clinicians identify those patients who will succeed and those who will fail under nasal high flow and therefore predict the need for intubation.
However, when nasal high flow therapy is successful, little is known as to how and when weaning of this device should be performed and what are the predictors of a safe withdrawal of the device.
The objectives of this retrospective exploratory study are to identify a cut-off value of the ROX index predictive of success of the withdrawal trial, to describe a one-year use of the withdrawal trial; to describe the ROX value closest to weaning from nasal high flow, and to identify factors associated with success or failure of the withdrawal trial from nasal high flow therapy in patients receiving nasal high flow therapy.
Descripción general del estudio
Estado
Terminado
Descripción detallada
Although nasal high flow is widely used in critically ill patients admitted to the intensive care unit (ICU) for acute hypoxemic respiratory failure, and its benefits have been shown in multiple studies, little is known as to how and when weaning from the technique device should be performed and what are the predictors of a safe withdrawal.
The Respiratory Oxygenation (ROX) index was established and tested to predict outcome of nasal high flow therapy in patients with acute hypoxemic respiratory failure.
It combines three parameters available at the bedside that reflect patient's respiratory status: respiratory rate, the level of the inspired fraction of oxygen (FiO2) and pulse oximetry (SpO2).
Importantly, the combination of these three parameters outweighed the performance of each parameter taken separately to predict nasal high flow therapy outcome.
Since its initial publication, several studies coming from different countries have confirmed the potential for the ROX index to predict need for intubation in patients with acute hypoxemic respiratory failure, thus making a valuable tool accessible to everyone, including nurses, to monitor on a routine basis.
Because it reflects the patient's respiratory status, the greater the score, the better the patient's condition.
Hence, one may hypothesize that, at the other end of the spectrum of respiratory failure (i.e., at the stage of weaning and withdrawal of the high flow device when the patient has considerably improved), the ROX index may also help identify those patients who will be successfully separated from the nasal high flow support.
To date, one study has suggested that among several parameters, the value of the ROX index could be associated with successful cessation of nasal high flow.
Here, in a retrospective exploratory study, investigators aim to to identify a cut-off value of the ROX index predictive of success of the withdrawal trial, to describe a one-year use of the withdrawal trial (average duration of use of nasal high flow before weaning, number of weaning trials, number of failed and successful weaning trials.); to describe the ROX value closest to weaning from nasal high flow, and to identify factors associated with success or failure of the withdrawal trial from nasal high flow therapy in patients receiving nasal high flow therapy; A successful withdrawal is defined as the withdrawal of nasal high flow without necessity of placing the patient back on nasal high flow within the following 24h.
A failed withdrawal is defined by the need to resume nasal high flow within the 24h hours following the withdrawal.
The possible identification of a cut-off value may help clinicians initiate earlier weaning from nasal high flow.
Tipo de estudio
De observación
Inscripción (Actual)
62
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Colombes, Francia, 92700
- Hôpital Louis Mourier, Assistance Publique - Hôpitaux de Paris
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años y mayores (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Método de muestreo
Muestra de probabilidad
Población de estudio
ICU patients treated with nasal high flow therapy
Descripción
Inclusion Criteria:
- ICU patient treated with nasal high flow
Exclusion Criteria:
- age < 18 years
- concomitant treatment with non-invasive ventilation
- acute hypercapnic respiratory failure
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Value of the Respiratory Oxygenation index (ROX) at nasal high flow withdrawal
Periodo de tiempo: through each nasal high flow therapy, that lasts an average of 24hours
|
the ROX index the closest to the time at which nasal high flow is withdrawn will be recorded
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through each nasal high flow therapy, that lasts an average of 24hours
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
use of nasal high flow before weaning
Periodo de tiempo: through each nasal high flow therapy, that lasts an average of 24 hours
|
average duration of nasal high flow therapy before initiating a withdrawal trial (in hours)
|
through each nasal high flow therapy, that lasts an average of 24 hours
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number of withdrawal trials
Periodo de tiempo: through each nasal high flow therapy, that lasts an average of 24 hours
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the number of trials each patient will have performed will be recorded
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through each nasal high flow therapy, that lasts an average of 24 hours
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number of patients who failed a withdrawal trial
Periodo de tiempo: throughout study duration which is a one-year period
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withdrawal failure is defined by patients who required to be placed back on nasal high flow after withdrawal of the high flow device within 24 hours of withdrawal.
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throughout study duration which is a one-year period
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number of patients who succeeded a withdrawal trial
Periodo de tiempo: throughout study duration which is a one-year period
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withdrawal success is defined by patients that have not required to be placed back on nasal high flow after withdrawal of the high flow device within 24 hours of withdrawal.
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throughout study duration which is a one-year period
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Investigador principal: Jean-Damien Ricard, MD, PhD, Assistance Publique - Hôpitaux de Paris
Publicaciones y enlaces útiles
La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.
Publicaciones Generales
- Roca O, Caralt B, Messika J, Samper M, Sztrymf B, Hernandez G, Garcia-de-Acilu M, Frat JP, Masclans JR, Ricard JD. An Index Combining Respiratory Rate and Oxygenation to Predict Outcome of Nasal High-Flow Therapy. Am J Respir Crit Care Med. 2019 Jun 1;199(11):1368-1376. doi: 10.1164/rccm.201803-0589OC.
- Ricard JD, Roca O, Lemiale V, Corley A, Braunlich J, Jones P, Kang BJ, Lellouche F, Nava S, Rittayamai N, Spoletini G, Jaber S, Hernandez G. Use of nasal high flow oxygen during acute respiratory failure. Intensive Care Med. 2020 Dec;46(12):2238-2247. doi: 10.1007/s00134-020-06228-7. Epub 2020 Sep 8.
- Rodriguez M, Thille AW, Boissier F, Veinstein A, Chatellier D, Robert R, Le Pape S, Frat JP, Coudroy R. Predictors of successful separation from high-flow nasal oxygen therapy in patients with acute respiratory failure: a retrospective monocenter study. Ann Intensive Care. 2019 Sep 11;9(1):101. doi: 10.1186/s13613-019-0578-8.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
1 de enero de 2019
Finalización primaria (Actual)
31 de diciembre de 2019
Finalización del estudio (Actual)
31 de agosto de 2021
Fechas de registro del estudio
Enviado por primera vez
11 de enero de 2022
Primero enviado que cumplió con los criterios de control de calidad
26 de enero de 2022
Publicado por primera vez (Actual)
27 de enero de 2022
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
27 de enero de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
26 de enero de 2022
Última verificación
1 de enero de 2022
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Procesos Patológicos
- Enfermedades de las vías respiratorias
- Trastornos de la respiración
- Enfermedades pulmonares
- Enfermedad
- Infantil, Recién Nacido, Enfermedades
- Lesión pulmonar
- Infantil, Prematuro, Enfermedades
- Síndrome
- Insuficiencia respiratoria
- Síndrome de Dificultad Respiratoria
- Síndrome de Dificultad Respiratoria, Recién Nacido
- Lesión pulmonar aguda
Otros números de identificación del estudio
- HLM_JDR11
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
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