Airway Management Study in Physician Manned Helicopter Emergency Medical Services

Trauma Clinical Trial

— AIRPORT  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01502111
• Other study ID #: NLA-3104-01/02
• Status: Completed
• Phase: N/A
• First received: December 22, 2011
• Last updated: May 7, 2013
• Start date: January 2012
• Est. completion date: March 2013

Study information

• Verified date: May 2013
• Source: Norwegian Air Ambulance Foundation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Data Protection Authority
• Study type: Observational

Clinical Trial Summary

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.

Description:

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:

1. 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.

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2333
• Est. completion date: March 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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).

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiac Arrest
• Emergencies
• Heart Arrest
• Trauma

Locations

Country	Name	City	State
Norway	Department of Research and Development, Norwegian Air Ambulance Foundation	Drøbak

Sponsors (2)

Lead Sponsor	Collaborator
Norwegian Air Ambulance Foundation	Haukeland University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants who survive to hospital admission		Time from injury/illness to admission hospital, up to 24 hours	No
Secondary	Number of participants with adverse events during airway interventions	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.	Time from injury/illness to admission hospital, up to 24 hours	No