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Pre-Hospital Advanced Airway Management in the Nordic Countries (PHAST)

21. August 2017 aktualisiert von: Mikael Gellerfors, Karolinska Institutet

Pre-Hospital Advanced Airway Management in the Nordic Countries - A Prospective Multicentre Observational Study

Pre-Hospital Advanced Airway Management (PHAAM) is a potentially lifesaving intervention. A recent Danish multicentre single country study demonstrated a 99,7% incidence of successful anaesthesiologist pre-hospital endotracheal intubation, with a PHAAM-related complication rate of 7.9%. A London study revealed a significantly higher intubation failure rate among non-anaesthesiologist physicians. In Scandinavia different types of emergency medical services (EMS) and professions provide PHAAM. The success rate of prehospital endotracheal intubation (PHETI), incidence of difficult intubation and complications in the Nordic countries is not known. The aim of this study is to define PHAAM success rate and complications in different types of Nordic EMS organisations and physician critical care teams. The study is a prospective observational study with collection of PHAAM data according to the template by Sollid et al. in the 12 participating Nordic Countries EMS/HEMS centres and physician critical care teams. The primary endpoint is PHETI success on ≤2 attempts and no complications.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Detaillierte Beschreibung

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

  1. Describe the characteristics and outcome of advanced prehospital airway management.
  2. 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.

Studientyp

Beobachtungs

Einschreibung (Tatsächlich)

2028

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

  • Schweden
    • VästraGötaland
      • Gothenburg, VästraGötaland, Schweden
        • HEMS VGR

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

  • Kind
  • Erwachsene
  • Älterer Erwachsener

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Wahrscheinlichkeitsstichprobe

Studienpopulation

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.

Beschreibung

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)

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Beobachtungsmodelle: Kohorte
  • Zeitperspektiven: Interessent

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
PHETI ≤ 2attempts and no complications
Zeitfenster: 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)

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
PHETI overall success rate
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: At hospital discharge (estimated average 7 days)
At hospital discharge (estimated average 7 days)
Mortalität
Zeitfenster: Bei 30 Tagen
Bei 30 Tagen
PHETI ≤ 2attempts and no complications among patients with TBI
Zeitfenster: 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)

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Karolinska Institutet

Mitarbeiter

Norwegian Air Ambulance Foundation

Ermittler

  • Studienstuhl: Hans Morten Lossius, MD, PhD, Norwegian Air Ambulance Foundation

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

1. Mai 2015

Primärer Abschluss (Tatsächlich)

1. November 2016

Studienabschluss (Tatsächlich)

1. März 2017

Studienanmeldedaten

Zuerst eingereicht

7. Mai 2015

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

18. Mai 2015

Zuerst gepostet (Schätzen)

21. Mai 2015

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

22. August 2017

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

21. August 2017

Zuletzt verifiziert

1. August 2017

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • PHAST-01

Plan für individuelle Teilnehmerdaten (IPD)

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Unentschieden

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

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