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High Flow Nasal Oxygen During Sedation

9 de novembro de 2020 atualizado por: Aaron Conway, University Health Network, Toronto

High Flow Nasal Oxygen During Conscious Sedation in the Cardiac Catheterisation Laboratory: A Randomized Controlled Trial

The primary objective of this study is to test the hypothesis that using high flow nasal oxygen improves ventilation during cardiac implantable electronic device procedures performed with conscious sedation. A randomized controlled trial design will be used with participants randomized in a 1:1 ratio to oxygen supplementation through a standard facemask or high flow nasal oxygen.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

High flow nasal oxygen (HFNO) is increasingly regarded as a promising technology for oxygen delivery in critical care and anesthetic management. Although promising, further high-quality studies examining the effects of using HFNO during procedural sedation are required to inform decision-making regarding implementation of this new technology into practice. The 2018 guidelines from the American Society of Anesthesiology stated that there is insufficient evidence regarding which methods of supplemental oxygen administration (e.g., nasal cannula, face mask, or specialized devices such as HFNO) are more effective. This trial will address this limitation in the evidence base specifically in regard to the efficacy of using HFNO during conscious sedation in the cardiac catheterisation laboratory.

Tipo de estudo

Intervencional

Inscrição (Real)

129

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

  • Canadá
    • Ontario
      • Toronto, Ontario, Canadá
        • Toronto General Hospital

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

16 anos e mais velhos (Filho, Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion criteria:

1. Adults undergoing an elective cardiac implantable electronic device procedure in the Peter Munk Cardiac Centre Cardiac Cath Labs with conscious sedation administered by an Anesthetic Assistant (de novo and replacement/revision procedures).

Exclusion criteria:

  1. Under 16 years of age.
  2. Underlying condition requiring chronic oxygen supplementation.
  3. Diagnosed respiratory condition with confirmed current hypercapnia.
  4. Pre-existing untreated pneumothorax.
  5. Transesophageal echocardiography planned for the procedure.
  6. Active nasal bleeding.
  7. Complete nasal obstruction.
  8. Recent upper airway surgery or base of skull fracture.
  9. Previous participation in the study.

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Pesquisa de serviços de saúde
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: High flow nasal oxygen
The gas temperature will commence at the 'High' setting (ranges 30-32º Celsius) and titrated downwards if the patient complains of irritation. The gas flow rate will commence at 30 liters per minute prior to sedation administration and be titrated up to 70 liters per minute as tolerated by the patient after sedation has been administered. The fraction of oxygen in the gas will be commenced at 50% (same as that delivered from 6 liters per minute via facemask) and can be titrated upward according to patient requirements (i.e. increased if there is evidence of hypoventilation, airway obstruction or inadequate oxygenation, decreased during use of diathermy). Anesthesia Assistants at the site will be provided with training in the use of this mode of oxygen delivery prior to study commencement.
Dispositivo: High flow nasal oxygen
The Optiflow device (Fisher and Paykel Healthcare, Auckland, New Zealand) will be used.
Outro: Standard oxygenation
Supplemental oxygen through a facemask with the flow rate chosen by the clinician responsible for sedation as per their standard practice. The oxygen flow rate is typically commenced at 6 liters per minute and can be titrated up to 15 liters per minute.
Dispositivo: Standard oxygenation
Supplemental oxygen through a facemask.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Peak transcutaneous carbon dioxide (TcCO2) concentration.
Prazo: From the time between first sedative medication administration to the end of the procedure. Estimated duration of procedures is 30 minutes to 120 minutes.
Continuous measurements will be recorded using the Sentec Digital Monitoring with VSign 2 sensor.
From the time between first sedative medication administration to the end of the procedure. Estimated duration of procedures is 30 minutes to 120 minutes.

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Mean transcutaneous carbon dioxide concentration
Prazo: From the time between first sedative medication administration to the end of the procedure. Estimated duration of procedures is 30 minutes to 120 minutes.
Continuous measurements will be recorded using the Sentec Digital Monitoring with VSign 2 sensor.
From the time between first sedative medication administration to the end of the procedure. Estimated duration of procedures is 30 minutes to 120 minutes.
Area under SpO2 90% oxygen desaturation curve
Prazo: From the time between first sedative medication administration to the end of the procedure. Estimated duration of procedures is 30 minutes to 120 minutes.
Percentage of hemoglobin saturated with oxygen (SpO2) will be measured continuously throughout procedures as part of routine clinical practice through the anaesthetic machine. This is a composite measure comprising the incidence, depth, and duration of oxygen desaturation events. Area under SpO2 90% oxygen desaturation curve is calculated as the difference between the threshold (90%) and actual oxygen saturation (SpO2) summed every second during which oxygen saturation was below threshold.
From the time between first sedative medication administration to the end of the procedure. Estimated duration of procedures is 30 minutes to 120 minutes.
Adverse sedation events
Prazo: From the time between first sedative medication administration to the end of the procedure. Estimated duration of procedures is 30 minutes to 120 minutes.
The Anaesthesia Assistant will be asked to complete the Tracking and reporting outcomes of procedural sedation (TROOPS) tool at the end of procedures. Completion of the tool requires identification and description of the adverse event, the intervention, the outcome and the overall severity of the adverse event.
From the time between first sedative medication administration to the end of the procedure. Estimated duration of procedures is 30 minutes to 120 minutes.
Patient satisfaction with sedation: Iowa Satisfaction with Anesthesia Scale
Prazo: After the participant has reached phase 2 post-anesthetic recovery. Estimated to be 30 minutes after procedure has finished.
Iowa Satisfaction with Anesthesia Scale. Score ranges from -3 (worse satisfaction) to +3 (better satisfaction).
After the participant has reached phase 2 post-anesthetic recovery. Estimated to be 30 minutes after procedure has finished.
Costs associated with oxygen delivery
Prazo: From the time between first sedative medication administration to the end of the procedure. Estimated duration of procedures is 30 minutes to 120 minutes.
Anesthesia Assistants will document devices used for supplemental oxygen delivery and airway management in both groups as per their usual practice in the anesthesia monitoring system.
From the time between first sedative medication administration to the end of the procedure. Estimated duration of procedures is 30 minutes to 120 minutes.
Anesthesia Assistant rating of difficulty maintaining the patient's oxygenation status
Prazo: To be completed as soon as possible after the end of the procedure (within about 5 minutes).
The Anaesthesia Assistant will be asked to rate their perceived level of difficulty in maintaining oxygenation using a 6-level rating scale with ratings of "extremely difficult", "very difficult", "difficult", "easy", "very easy", "extremely easy".
To be completed as soon as possible after the end of the procedure (within about 5 minutes).
Anesthesia Assistant rating of difficulty using oxygen delivery device
Prazo: To be completed as soon as possible after the end of the procedure (within about 5 minutes).
The Anaesthesia Assistant will be asked to rate their perceived level of difficulty using the oxygen delivery device using a 6-level rating scale with ratings of "extremely difficult", "very difficult", "difficult", "easy", "very easy", "extremely easy".
To be completed as soon as possible after the end of the procedure (within about 5 minutes).
Patient comfort of oxygen delivery
Prazo: After the participant has reached phase 2 post-anesthetic recovery. Estimated to be 30 minutes after procedure has finished.
Participants will be asked to rate at the end of procedures their perceived overall comfort with the oxygen delivery device used during the procedure using a 6-level rating scale with ratings of 'maximal discomfort', 'very uncomfortable', 'uncomfortable', 'comfortable', 'very comfortable' and 'maximal comfort'.
After the participant has reached phase 2 post-anesthetic recovery. Estimated to be 30 minutes after procedure has finished.
Trajectory of transcutaneous carbon dioxide as a function of time
Prazo: From the time between first sedative medication administration to the end of the procedure. Estimated duration of procedures is 30 minutes to 120 minutes.
Continuous measurements will be recorded using the Sentec Digital Monitoring with VSign 2 sensor
From the time between first sedative medication administration to the end of the procedure. Estimated duration of procedures is 30 minutes to 120 minutes.

Colaboradores e Investigadores

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

Patrocinador

University Health Network, Toronto

Investigadores

  • Investigador principal: Aaron Conway, RN, PhD, University Health Network, Toronto

Publicações e links úteis

A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.

Publicações Gerais

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)

7 de agosto de 2019

Conclusão Primária (Real)

12 de março de 2020

Conclusão do estudo (Real)

12 de março de 2020

Datas de inscrição no estudo

Enviado pela primeira vez

25 de fevereiro de 2019

Enviado pela primeira vez que atendeu aos critérios de CQ

27 de fevereiro de 2019

Primeira postagem (Real)

28 de fevereiro de 2019

Atualizações de registro de estudo

Última Atualização Postada (Real)

12 de novembro de 2020

Última atualização enviada que atendeu aos critérios de controle de qualidade

9 de novembro de 2020

Última verificação

1 de novembro de 2020

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • 18-6343

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

SIM

Descrição do plano IPD

Study data, participant-level data sets (without identifying information) and code for statistical analyses will be shared in a publicly accessible repository at the time of publication.

Prazo de Compartilhamento de IPD

With publication of results.

Critérios de acesso de compartilhamento IPD

Available through a public repository

Tipo de informação de suporte de compartilhamento de IPD

  • PROTOCOLO DE ESTUDO
  • SEIVA
  • CIF
  • ANALYTIC_CODE

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

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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