Effects of Laryngeal Tube Ventilation on no Flow Time During Out of Hospital Cardiac Arrest (FLOWERS)
2 de julho de 2012 atualizado por: University Hospital, Grenoble
Reduction of no Flow Time During Out of Hospital Cardiac Arrest by Using Laryngeal Tube for Airway Management by Nurses.
International recommendations stress on the importance of no flow time reduction in cardiac arrest management. In fact, no flow time is an independent factor of morbidity and mortality.
In France, cardiac arrests are treated by first responders (including emergency nurses) before the arrival of a mobile intensive care unit. Those first responders use bag-valve-mask for ventilation and therefore practice conventional CPR (30 chest compression / 2 ventilation rhythm). Laryngeal tube is a safe and efficient device in cardiac arrest ventilation. The purpose of our study is to compare the no flow time between two strategies of out of hospital cardiac arrest management by first responders: conventional CPR with bag-valve-mask ventilation vs. compression only CPR with Laryngeal Tube ventilation.
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Descrição detalhada
Multicentric, prospective, controlled, randomized study with parallel groups in single blind.
Patients will be included in chronological periods to avoid selection biais (one month with the first medical device the next month with the other one). The determination of these periods will be centralized. The emergency vehicles will be supplied sufficiently with devices. This design has been chosen in order to answer to the emergency problem.
Patients will be included and ventilated by paramedical staff (first responders) before medical staff (Mobile Intensive Care Unit) intervention. Complete detailed information will be given to the patient or to the family and consent asked.
The comparison of no flow time between the two strategies in out of hospital cardiac arrest will be the following :
A : ventilation by bag valve mask and interrupted chest compression B : ventilation by laryngeal tube and continuous chest compression
Tipo de estudo
Intervencional
Inscrição (Real)
84
Estágio
- Fase 3
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
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Isere
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Fontaine, Isere, França, 38602
- SDIS
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Grenoble, Isere, França, 38043
- Samu Smur
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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
Descrição
Inclusion Criteria:
- preliminary treatment of cardiac arrest by fire fighters (Basic Life support)
- more than 18 years
- patient affiliated to the social security system or equivalent
Exclusion Criteria:
- certain death
- patient deprived of freedom by judicial or administrative decision
- patient under legal protection
- Pregnancy, parturient or breast feeding
- facial trauma
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 |
|---|---|
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Comparador Ativo: ventilation by laryngeal tube
ventilation by laryngeal tube and continuous chest compression
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Comparison of no flow time between two strategies in out of hospital cardiac arrest
Outros nomes:
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Comparador Falso: ventilation by bag valve mask
ventilation by bag valve mask and interrupted chest compression
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Comparison of no flow time between two strategies in out of hospital cardiac arrest
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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comparison of no flow time between two strategies
Prazo: arrival of paramedical staff T0
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group A : ventilation by bag valve mask and interrupted chest compression group B : ventilation by laryngeal tube and continuous chest compression outcome measure : time of no flow during Resuscitation by trained paramedical staff in out of hospital cardiac arrest |
arrival of paramedical staff T0
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
Prazo: during cardiac arrest at T0
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No flow proportion during resuscitation by paramedical staff after emergency training
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during cardiac arrest at T0
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qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
Prazo: during cardiac arrest at T0
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no flow proportion on total resuscitation duration
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during cardiac arrest at T0
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qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
Prazo: during cardiac arrest at T0
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number of failure installation after 2 tests
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during cardiac arrest at T0
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qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
Prazo: during cardiac arrest at T0
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Time of device installation
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during cardiac arrest at T0
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qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
Prazo: during cardiac arrest at T0
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chest expansion during insuflation (yes/no)
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during cardiac arrest at T0
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qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
Prazo: during cardiac arrest at T0
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Mortality : spontaneous cardiac activity recovery, hospital admission, reanimation service or hospital exit date, survival at 28 days , CPC evaluation for patients alive
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during cardiac arrest at T0
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qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
Prazo: during cardiac arrest at T0
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incident during ventilation : obstruction number of manipulations to optimize ventilation |
during cardiac arrest at T0
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qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
Prazo: during cardiac arrest at T0
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ETCO2
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during cardiac arrest at T0
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qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
Prazo: during cardiac arrest at T0
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Number of external electric shocks
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during cardiac arrest at T0
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qualitative observation of laryngeal tube use for ventilation of patients in cardiac arrest
Prazo: during cardiac arrest a T0
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degradation due to technical manipulations
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during cardiac arrest a T0
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Vincent Danel, MD, University Hospital, Grenoble
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.
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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
1 de março de 2011
Conclusão Primária (Real)
1 de fevereiro de 2012
Conclusão do estudo (Real)
1 de junho de 2012
Datas de inscrição no estudo
Enviado pela primeira vez
11 de fevereiro de 2011
Enviado pela primeira vez que atendeu aos critérios de CQ
11 de fevereiro de 2011
Primeira postagem (Estimativa)
14 de fevereiro de 2011
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
3 de julho de 2012
Última atualização enviada que atendeu aos critérios de controle de qualidade
2 de julho de 2012
Última verificação
1 de julho de 2012
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- DCIC - 1014
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