Pre-Hospital Advanced Airway Management in the Nordic Countries (PHAST)
Pre-Hospital Advanced Airway Management in the Nordic Countries - A Prospective Multicentre Observational Study
Descripción general del estudio
Estado
Descripción detallada
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 estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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VästraGötaland
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Gothenburg, VästraGötaland, Suecia
- HEMS VGR
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Grupo
- Perspectivas temporales: Futuro
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
PHETI ≤ 2attempts and no complications
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
PHETI overall success rate
Periodo de tiempo: 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
Periodo de tiempo: 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.)
|
At hospital admission (</= 1 day)
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|
PHETI success rate on 1st, 2nd, 3rd and >3rd attempt
Periodo de tiempo: 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
Periodo de tiempo: 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)
|
|
Success rate of airway back-up devices
Periodo de tiempo: At hospital admission (</= 1 day)
|
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.)
|
At hospital admission (</= 1 day)
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Pre-hospital mortality
Periodo de tiempo: 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
Periodo de tiempo: At hospital admission (</= 1 day)
|
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
Periodo de tiempo: At hospital discharge (estimated average 7 days)
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At hospital discharge (estimated average 7 days)
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Mortalidad
Periodo de tiempo: A los 30 días
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A los 30 días
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PHETI ≤ 2attempts and no complications among patients with TBI
Periodo de tiempo: 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
- Silla de estudio: Hans Morten Lossius, MD, PhD, Norwegian Air Ambulance Foundation
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
- Seguridad del paciente
- Prehospitalario
- Fuera del hospital
- Atención de emergencia prehospitalaria (DeCS)
- Servicios médicos de emergencia (DeCS)
- Servicio médico de emergencia en helicóptero.
- Critical care (MeSH)
- Manejo de la vía aérea (MeSH)
- Intubación endotraqueal (MeSH)
- Intubación endotraqueal difícil
- Complications (MeSH)
Términos MeSH relevantes adicionales
- Procesos Patológicos
- Enfermedades Cerebrales
- Enfermedades del Sistema Nervioso Central
- Enfermedades del Sistema Nervioso
- Enfermedades de las vías respiratorias
- Trastornos de la respiración
- Heridas y Lesiones
- Atributos de la enfermedad
- Trauma craneoencefálico
- Trauma, Sistema Nervioso
- Signos y Síntomas Respiratorios
- Insuficiencia respiratoria
- Emergencias
- Lesiones Cerebrales
- Lesiones Cerebrales Traumáticas
- Obstrucción de la vía aerea
- Hipoventilación
Otros números de identificación del estudio
- PHAST-01
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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