- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT01502111
Airway Management Study in Physician Manned Helicopter Emergency Medical Services (AIRPORT)
Improved Knowledge Through Better Data, Implementing and Evaluating a Novel Consensus-based Template for Uniform Reporting of Data From Pre-hospital Airway Management - a Prospective Multicentre Observational Study
Tutkimuksen yleiskatsaus
Tila
Yksityiskohtainen kuvaus
Advanced airway management and ventilatory control is generally regarded as vital in the management of seriously ill or injured patients, and can be critical interventions in patients with out-of-hospital emergencies. However, interventions like endotracheal intubation suffer from lack of clear evidence of a beneficial effect. Despite the publication of numerous airway management studies, inconsistent and imprecise reporting of data across heterogenous patient populations and EMS systems persists. The questions of how, and by whom, pre-hospital advanced airway management should be performed remains disputed.
Several authors have proposed appropriate guidelines and algorithms for management of prehospital airway and difficult intubation. The guidelines emphasize the importance of promoting patient safety and avoiding errors, and also recognise the importance of rescuers level of airway skills competence. Drug-assisted rapid sequence intubation (RSI) is an important, but potentially harmful, component of prehospital advanced airway management in EMS services. Even physicians working in the prehospital scene may find it challenging to maintain an adequate level of advanced airway competence in order to stay proficient. Better training methods and systems are warranted.
The recognition of endotracheal intubation as a "complex intervention" marks the need for an international standard for documenting and reporting data from prehospital intubations in severely injured or ill patients, alongside a standardization of research data collection to eliminate confounding factors. An international airway management expert group has recently developed an Utstein-style template for uniform reporting of data from prehospital advanced airway management. Implementing and validating the template will result in a high quality dataset and allow for research cooperation and comparison of airway management practice between EMS systems, and across different patient populations. Such a dataset will hopefully contribute to new knowledge in the field of prehospital advanced airway management.
The specific aims for the first two studies in this project are defined as follows:
- Describe the characteristics and outcome of advanced prehospital airway management in Helicopter Emergency Medical Services (HEMS) that provide the full range of advanced emergency 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.
In this multicentre study, we have enlisted 21 key international HEMS services from 6 countries (UK, Australia, Hungary, Finland, Switzerland and Norway), and will collect data according to the Utstein style template over a 12 month study period starting January 1, 2012.
Opintotyyppi
Ilmoittautuminen (Todellinen)
Yhteystiedot ja paikat
Opiskelupaikat
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Drøbak, Norja, 1441
- Department of Research and Development, Norwegian Air Ambulance Foundation
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
- Lapsi
- Aikuinen
- Vanhempi Aikuinen
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Näytteenottomenetelmä
Tutkimusväestö
Patients receiving advanced airway management in physician manned helicopter emergency medical services over a 12-month period.
Data reported according to the Utstein style template for uniform reporting of data from prehospital advanced airway management
Kuvaus
Inclusion Criteria:
- All patients requiring and receiving prehospital advanced airway management on HEMS primary missions.
- Advanced airway management is defined as the attempted insertion of an advanced airway adjunct (including endotracheal intubation, alternative airways, and surgical airway /cricothyroidectomy) or the administration of ventilatory assistance/support (including bag-mask ventilation-BMV, BIPAP/CPAP or other ventilatory support).
- Advanced prehospital advanced airway management is further defined as any airway management beyond manual opening of the airway and use of simple airway adjuncts, such as a Guedel airway or supplemental oxygen
Exclusion Criteria:
- Patients receiving advanced airway management during so-called secondary missions (or inter-hospital transfer).
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
Kohortit ja interventiot
Ryhmä/Kohortti |
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Airway management
Patients receiving advanced airway management in physician manned helicopter emergency medical services over a 12-month period.
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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Aikaikkuna |
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Number of participants who survive to hospital admission
Aikaikkuna: Time from injury/illness to admission hospital, up to 24 hours
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Time from injury/illness to admission hospital, up to 24 hours
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Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
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Number of participants with adverse events during airway interventions
Aikaikkuna: Time from injury/illness to admission hospital, up to 24 hours
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Airway intervention success rates and airway management related complications.
We will calculate airway intervention success rates, frequency and complications for the entire cohort and for key subsets (like cardiac arrest, medical, trauma, pediatric patients and RSI/alternative airways), population demographics and prevalence of adverse effects (like missed intubations, bradycardia, hypotension, hypoxia).
Outcome and patient characteristics will be analysed and described.
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Time from injury/illness to admission hospital, up to 24 hours
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Yhteistyökumppanit ja tutkijat
Sponsori
Yhteistyökumppanit
Tutkijat
- Päätutkija: Geir A Sunde, MD, Norwegian Air Ambulance Foundation
- Opintojen puheenjohtaja: Stephen Sollid, MD, PhD, Norwegian Air Ambulance Foundation
Julkaisuja ja hyödyllisiä linkkejä
Yleiset julkaisut
- Sunde GA, Sandberg M, Lyon R, Fredriksen K, Burns B, Hufthammer KO, Roislien J, Soti A, Jantti H, Lockey D, Heltne JK, Sollid SJM. Hypoxia and hypotension in patients intubated by physician staffed helicopter emergency medical services - a prospective observational multi-centre study. BMC Emerg Med. 2017 Jul 11;17(1):22. doi: 10.1186/s12873-017-0134-5.
- Sunde GA, Heltne JK, Lockey D, Burns B, Sandberg M, Fredriksen K, Hufthammer KO, Soti A, Lyon R, Jantti H, Kamarainen A, Reid BO, Silfvast T, Harm F, Sollid SJ; Airport Study Group. Airway management by physician-staffed Helicopter Emergency Medical Services - a prospective, multicentre, observational study of 2,327 patients. Scand J Trauma Resusc Emerg Med. 2015 Aug 7;23:57. doi: 10.1186/s13049-015-0136-9.
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Arvio)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Arvio)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
Muut tutkimustunnusnumerot
- NLA-3104-01/02
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