Pre-Hospital Advanced Airway Management in the Nordic Countries (PHAST)
Pre-Hospital Advanced Airway Management in the Nordic Countries - A Prospective Multicentre Observational Study
Visão geral do estudo
Status
Descrição detalhada
Pre-Hospital Advanced Airway Management (PHAAM) is a potentially lifesaving intervention. A recent meta-analysis of >15.000 patients reported a variation in the prehospital endotracheal intubation (PHETI) success rate with different methods used and provider background. A recent prehospital study from London revealed a significantly higher intubation failure rate among non-anaesthesiologist physicians. In Scandinavia different types of emergency medical services (EMS) and professionals provide PHAAM. The success rate of PHETI, incidence of difficult intubation and complications in the Nordic countries is not known. Although the EMS structure in Scandinavia is reasonably similar, there are some inter- and intra-national differences regarding mission profile, staffing, systems for dispatch and on-scene management. A Danish PHAAM study demonstrated a 99,7% anaesthesiologist PHETI success rate with a 7,9% complication rate. The authors concluded the study was from a homogenous Danish system limiting the ability to generalise the findings to other systems with different staffing, caseload or case mix.
The PHAST investigators aim to provide prospective multicentre data on the pre-hospital intubation success rate and complications in the Nordic countries. Additionally the investigators will compare the PHAAM procedure for different subgroups of patients, regions and EMS organisations.
In the PHAST observational study twelve Nordic (Sweden, Norway, Denmark and Finland) Helicopter and Rapid Response Emergency Medical Services will include patients during 18 months. The decision to perform PHAAM is based on the discretion of prehospital provider. The PHAAM core data will be prospectively collected according the template by Sollid et al.
The primary endpoint is PHETI success on ≤2 attempts and no complications. Secondary endpoints include overall PHETI success rate, PHETI success on 1st, 2nd, 3rd and >3rd attempt, difficult PHETI, success rate of laryngeal mask and surgical airway, PHAAM complications and prehospital mortality.
Through predefined analysis of the data, the PHAST investigators hope to
- Describe the characteristics and outcome of advanced prehospital airway management.
- Identify which groups of critically injured or ill patients will benefit most from competent advanced prehospital airway management, and identify specific areas for future research.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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VästraGötaland
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Gothenburg, VästraGötaland, Suécia
- HEMS VGR
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
All patients requiring prehospital advanced airway management (PHAAM) by the Helicopter Emergency Medical Services (EMS) and Ground EMS (GEMS) units in the study. PHAAM includes endotracheal intubation, supraglottic airway and percutaneous/surgical airway. The indications for performing PHAAM as categorised by Sollid et al. are
- Decreased level of consciousness
- Hypoxemia
- Ineffective ventilation
- Existing airway obstruction
- Impending airway obstruction
- Combative or uncooperative patient
- Relief of pain or distress
- Cardiopulmonary arrest
- Other
Exclusion Criteria:
- Patients receiving advanced airway management during so-called secondary missions (or inter-hospital transfer)
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: Coorte
- Perspectivas de Tempo: Prospectivo
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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PHETI ≤ 2attempts and no complications
Prazo: At hospital admission (</= 1 day)
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Prehospital Endotracheal Intubation success and complications as defined by Sollid et al (Sollid SJ, Lockey D, Lossius HM: A consensus-based template for uniform reporting of data from pre-hospital advanced airway management.
Scand J Trauma Resusc Emerg Med 2009, 17:58.)
|
At hospital admission (</= 1 day)
|
Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
PHETI overall success rate
Prazo: At hospital admission (</= 1 day)
|
PHETI= Prehospital Endotracheal Intubation as defined by Sollid et al (Sollid SJ, Lockey D, Lossius HM: A consensus-based template for uniform reporting of data from pre-hospital advanced airway management.
Scand J Trauma Resusc Emerg Med 2009, 17:58.)
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At hospital admission (</= 1 day)
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PHETI success on 1st attempt and no complications
Prazo: At hospital admission (</= 1 day)
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Endpoint as defined by Sollid et al (Sollid SJ, Lockey D, Lossius HM: A consensus-based template for uniform reporting of data from pre-hospital advanced airway management.
Scand J Trauma Resusc Emerg Med 2009, 17:58.)
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At hospital admission (</= 1 day)
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PHETI success rate on 1st, 2nd, 3rd and >3rd attempt
Prazo: At hospital admission (</= 1 day)
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PHETI success as defined by Sollid et al (Sollid SJ, Lockey D, Lossius HM: A consensus-based template for uniform reporting of data from pre-hospital advanced airway management.
Scand J Trauma Resusc Emerg Med 2009, 17:58.)
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At hospital admission (</= 1 day)
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PHAAM Complications
Prazo: At hospital admission (</= 1 day)
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PHAAM Complications as defined by Sollid et al (Sollid SJ, Lockey D, Lossius HM: A consensus-based template for uniform reporting of data from pre-hospital advanced airway management.
Scand J Trauma Resusc Emerg Med 2009, 17:58.)
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At hospital admission (</= 1 day)
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Success rate of airway back-up devices
Prazo: At hospital admission (</= 1 day)
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Endpoint as defined by Sollid et al (Sollid SJ, Lockey D, Lossius HM: A consensus-based template for uniform reporting of data from pre-hospital advanced airway management.
Scand J Trauma Resusc Emerg Med 2009, 17:58.)
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At hospital admission (</= 1 day)
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Pre-hospital mortality
Prazo: At hospital admission (</= 1 day)
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Endpoint as defined by Sollid et al (Sollid SJ, Lockey D, Lossius HM: A consensus-based template for uniform reporting of data from pre-hospital advanced airway management.
Scand J Trauma Resusc Emerg Med 2009, 17:58.)
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At hospital admission (</= 1 day)
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Other pre-specified endpoints and analysis as defined by the ERB-submitted protocol
Prazo: At hospital admission (</= 1 day)
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Endpoints as defined by Sollid et al (Sollid SJ, Lockey D, Lossius HM: A consensus-based template for uniform reporting of data from pre-hospital advanced airway management.
Scand J Trauma Resusc Emerg Med 2009, 17:58.)
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At hospital admission (</= 1 day)
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Mortality
Prazo: At hospital discharge (estimated average 7 days)
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At hospital discharge (estimated average 7 days)
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Mortalidade
Prazo: Aos 30 dias
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Aos 30 dias
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PHETI ≤ 2attempts and no complications among patients with TBI
Prazo: At hospital discharge (estimated average 7 days)
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PHETI ≤ 2attempts and no complications among subgroup of patients with Traumatic Brain Injury.
Prehospital Advanced Airway Management (PHAAM) success and complications as defined by Sollid et al (Sollid SJ, Lockey D, Lossius HM: A consensus-based template for uniform reporting of data from pre-hospital advanced airway management.
Scand J Trauma Resusc Emerg Med 2009, 17:58.)
|
At hospital discharge (estimated average 7 days)
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Cadeira de estudo: Hans Morten Lossius, MD, PhD, Norwegian Air Ambulance Foundation
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
- Segurança do paciente
- Pré-hospitalar
- Fora do hospital
- Atendimento pré-hospitalar de emergência (MeSH)
- Serviços médicos de emergência (MeSH)
- Serviço médico de emergência de helicóptero
- Critical care (MeSH)
- Gerenciamento de vias aéreas (MeSH)
- Intubação endotraqueal (MeSH)
- Intubação endotraqueal difícil
- Complications (MeSH)
Termos MeSH relevantes adicionais
- Processos Patológicos
- Doenças Cerebrais
- Doenças do Sistema Nervoso Central
- Doenças do Sistema Nervoso
- Doenças Respiratórias
- Distúrbios Respiratórios
- Ferimentos e Lesões
- Atributos da doença
- Trauma Craniocerebral
- Trauma, Sistema Nervoso
- Sinais e Sintomas Respiratórios
- Insuficiência Respiratória
- Emergências
- Lesões cerebrais
- Lesões Cerebrais Traumáticas
- Obstrução de vias aéreas
- Hipoventilação
Outros números de identificação do estudo
- PHAST-01
Plano para dados de participantes individuais (IPD)
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