- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus 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
Tutkimuksen yleiskatsaus
Tila
Yksityiskohtainen kuvaus
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.
Opintotyyppi
Ilmoittautuminen (Todellinen)
Yhteystiedot ja paikat
Opiskelupaikat
-
-
VästraGötaland
-
Gothenburg, VästraGötaland, Ruotsi
- HEMS VGR
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Lapsi
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Näytteenottomenetelmä
Tutkimusväestö
Kuvaus
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)
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Havaintomallit: Kohortti
- Aikanäkymät: Tulevaisuuden
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
PHETI ≤ 2attempts and no complications
Aikaikkuna: 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)
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
PHETI overall success rate
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: At hospital discharge (estimated average 7 days)
|
At hospital discharge (estimated average 7 days)
|
|
|
Kuolleisuus
Aikaikkuna: 30 päivän kohdalla
|
30 päivän kohdalla
|
|
|
PHETI ≤ 2attempts and no complications among patients with TBI
Aikaikkuna: 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)
|
Yhteistyökumppanit ja tutkijat
Sponsori
Yhteistyökumppanit
Tutkijat
- Opintojen puheenjohtaja: Hans Morten Lossius, MD, PhD, Norwegian Air Ambulance Foundation
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Arvio)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
- Patologiset prosessit
- Aivojen sairaudet
- Keskushermoston sairaudet
- Hermoston sairaudet
- Hengityselinten sairaudet
- Hengityshäiriöt
- Haavat ja vammat
- Sairauden ominaisuudet
- Kranioaivo-trauma
- Trauma, hermosto
- Merkit ja oireet, Hengityselimet
- Hengityksen vajaatoiminta
- Hätätilanteet
- Aivovammat
- Aivovammat, traumaattiset
- Hengitysteiden tukos
- Hypoventilaatio
Muut tutkimustunnusnumerot
- PHAST-01
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