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- Essai clinique NCT02450071
Pre-Hospital Advanced Airway Management in the Nordic Countries (PHAST)
Pre-Hospital Advanced Airway Management in the Nordic Countries - A Prospective Multicentre Observational Study
Aperçu de l'étude
Statut
Description détaillée
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.
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
-
-
VästraGötaland
-
Gothenburg, VästraGötaland, Suède
- HEMS VGR
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
- Enfant
- Adulte
- Adulte plus âgé
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: Cohorte
- Perspectives temporelles: Éventuel
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
PHETI ≤ 2attempts and no complications
Délai: At hospital admission (</= 1 day)
|
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)
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
PHETI overall success rate
Délai: 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.)
|
At hospital admission (</= 1 day)
|
PHETI success on 1st attempt and no complications
Délai: 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)
|
PHETI success rate on 1st, 2nd, 3rd and >3rd attempt
Délai: At hospital admission (</= 1 day)
|
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.)
|
At hospital admission (</= 1 day)
|
PHAAM Complications
Délai: At hospital admission (</= 1 day)
|
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.)
|
At hospital admission (</= 1 day)
|
Success rate of airway back-up devices
Délai: 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)
|
Pre-hospital mortality
Délai: 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)
|
Other pre-specified endpoints and analysis as defined by the ERB-submitted protocol
Délai: 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.)
|
At hospital admission (</= 1 day)
|
Mortality
Délai: At hospital discharge (estimated average 7 days)
|
At hospital discharge (estimated average 7 days)
|
|
Mortalité
Délai: A 30 jours
|
A 30 jours
|
|
PHETI ≤ 2attempts and no complications among patients with TBI
Délai: At hospital discharge (estimated average 7 days)
|
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)
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chaise d'étude: Hans Morten Lossius, MD, PhD, Norwegian Air Ambulance Foundation
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
- Sécurité du patient
- Pré-hospitalier
- Hors hôpital
- Soins préhospitaliers d'urgence (MeSH)
- Services médicaux d'urgence (MeSH)
- Helicopter emergency medical service
- Critical care (MeSH)
- Gestion des voies respiratoires (MeSH)
- Intubation endotrachéale (MeSH)
- Intubation endotrachéale difficile
- Complications (MeSH)
Termes MeSH pertinents supplémentaires
- Processus pathologiques
- Maladies du cerveau
- Maladies du système nerveux central
- Maladies du système nerveux
- Maladies des voies respiratoires
- Troubles respiratoires
- Blessures et Blessures
- Attributs de la maladie
- Traumatisme crânio-cérébral
- Traumatisme, système nerveux
- Signes et symptômes respiratoires
- Insuffisance respiratoire
- Urgences
- Lésions cérébrales
- Lésions cérébrales, traumatiques
- Obstruction des voies respiratoires
- Hypoventilation
Autres numéros d'identification d'étude
- PHAST-01
Plan pour les données individuelles des participants (IPD)
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Informations sur les médicaments et les dispositifs, documents d'étude
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