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NCT Number: NCT01502111

Airway Management Study in Physician Manned Helicopter Emergency Medical Services

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.

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Primary outcomes

  1. Number of participants who survive to hospital admission

    Time frame: Time from injury/illness to admission hospital, up to 24 hours

Secondary outcomes

  1. Number of participants with adverse events during airway interventions

    Time frame: Time from injury/illness to admission hospital, up to 24 hours

    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.

Sponsors and collaborators

Lead sponsor

Norwegian Air Ambulance Foundation

Other

Collaborators

  • Haukeland University Hospital

Registry information

Official study title

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

Acronym: AIRPORT

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 30, 2011
Registry last updated
May 8, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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