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Weaning From Nasal High Flow Therapy

26 de janeiro de 2022 atualizado 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.

Visão geral do estudo

Descrição detalhada

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 estudo

Observacional

Inscrição (Real)

62

Contactos e Locais

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Locais de estudo

      • Colombes, França, 92700
        • Hôpital Louis Mourier, Assistance Publique - Hôpitaux de Paris

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos e mais velhos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Método de amostragem

Amostra de Probabilidade

População do estudo

ICU patients treated with nasal high flow therapy

Descrição

Inclusion Criteria:

- ICU patient treated with nasal high flow

Exclusion Criteria:

  • age < 18 years
  • concomitant treatment with non-invasive ventilation
  • acute hypercapnic respiratory failure

Plano de estudo

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Como o estudo é projetado?

Detalhes do projeto

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Value of the Respiratory Oxygenation index (ROX) at nasal high flow withdrawal
Prazo: 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
through each nasal high flow therapy, that lasts an average of 24hours

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
use of nasal high flow before weaning
Prazo: 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
number of withdrawal trials
Prazo: through each nasal high flow therapy, that lasts an average of 24 hours
the number of trials each patient will have performed will be recorded
through each nasal high flow therapy, that lasts an average of 24 hours
number of patients who failed a withdrawal trial
Prazo: throughout study duration which is a one-year period
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.
throughout study duration which is a one-year period
number of patients who succeeded a withdrawal trial
Prazo: throughout study duration which is a one-year period
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.
throughout study duration which is a one-year period

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Patrocinador

Investigadores

  • Investigador principal: Jean-Damien Ricard, MD, PhD, Assistance Publique - Hôpitaux de Paris

Publicações e links úteis

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Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

1 de janeiro de 2019

Conclusão Primária (Real)

31 de dezembro de 2019

Conclusão do estudo (Real)

31 de agosto de 2021

Datas de inscrição no estudo

Enviado pela primeira vez

11 de janeiro de 2022

Enviado pela primeira vez que atendeu aos critérios de CQ

26 de janeiro de 2022

Primeira postagem (Real)

27 de janeiro de 2022

Atualizações de registro de estudo

Última Atualização Postada (Real)

27 de janeiro de 2022

Última atualização enviada que atendeu aos critérios de controle de qualidade

26 de janeiro de 2022

Última verificação

1 de janeiro de 2022

Mais Informações

Termos relacionados a este estudo

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

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