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

21 augusti 2017 uppdaterad av: 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.

Studieöversikt

Status

Avslutad

Betingelser

Detaljerad beskrivning

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.

Studietyp

Observationell

Inskrivning (Faktisk)

2028

Kontakter och platser

Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.

Studieorter

  • Sverige
    • VästraGötaland
      • Gothenburg, VästraGötaland, Sverige
        • HEMS VGR

Deltagandekriterier

Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.

Urvalskriterier

Åldrar som är berättigade till studier

  • Barn
  • Vuxen
  • Äldre vuxen

Tar emot friska volontärer

Nej

Kön som är behöriga för studier

Allt

Testmetod

Sannolikhetsprov

Studera befolkning

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.

Beskrivning

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)

Studieplan

Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.

Hur är studien utformad?

Designdetaljer

  • Observationsmodeller: Kohort
  • Tidsperspektiv: Blivande

Vad mäter studien?

Primära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
PHETI ≤ 2attempts and no complications
Tidsram: 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)

Sekundära resultatmått

Resultatmått
Åtgärdsbeskrivning
Tidsram
PHETI overall success rate
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: At hospital discharge (estimated average 7 days)
At hospital discharge (estimated average 7 days)
Dödlighet
Tidsram: Vid 30 dagar
Vid 30 dagar
PHETI ≤ 2attempts and no complications among patients with TBI
Tidsram: 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)

Samarbetspartners och utredare

Det är här du hittar personer och organisationer som är involverade i denna studie.

Sponsor

Karolinska Institutet

Samarbetspartners

Norwegian Air Ambulance Foundation

Utredare

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

Studieavstämningsdatum

Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.

Studera stora datum

Studiestart (Faktisk)

1 maj 2015

Primärt slutförande (Faktisk)

1 november 2016

Avslutad studie (Faktisk)

1 mars 2017

Studieregistreringsdatum

Först inskickad

7 maj 2015

Först inskickad som uppfyllde QC-kriterierna

18 maj 2015

Första postat (Uppskatta)

21 maj 2015

Uppdateringar av studier

Senaste uppdatering publicerad (Faktisk)

22 augusti 2017

Senaste inskickade uppdateringen som uppfyllde QC-kriterierna

21 augusti 2017

Senast verifierad

1 augusti 2017

Mer information

Termer relaterade till denna studie

Nyckelord

Ytterligare relevanta MeSH-villkor

Andra studie-ID-nummer

  • PHAST-01

Plan för individuella deltagardata (IPD)

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