Airway Management Study in Physician Manned Helicopter Emergency Medical Services (AIRPORT)

This study has been completed.
Sponsor:
Collaborator:
Haukeland University Hospital
Information provided by (Responsible Party):
Norwegian Air Ambulance Foundation
ClinicalTrials.gov Identifier:
NCT01502111
First received: December 22, 2011
Last updated: May 7, 2013
Last verified: May 2013
  Purpose

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.


Condition
Trauma
Cardiac Arrest
Emergencies

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by NLM:


Further study details as provided by Norwegian Air Ambulance Foundation:

Primary Outcome Measures:
  • Number of participants who survive to hospital admission [ Time Frame: Time from injury/illness to admission hospital, up to 24 hours ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Number of participants with adverse events during airway interventions [ Time Frame: Time from injury/illness to admission hospital, up to 24 hours ] [ Designated as safety issue: No ]
    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.


Enrollment: 2333
Study Start Date: January 2012
Study Completion Date: March 2013
Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Airway management
Patients receiving advanced airway management in physician manned helicopter emergency medical services over a 12-month period.

Detailed 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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01502111

Locations
Norway
Department of Research and Development, Norwegian Air Ambulance Foundation
Drøbak, Norway, 1441
Sponsors and Collaborators
Norwegian Air Ambulance Foundation
Haukeland University Hospital
Investigators
Study Chair: Stephen Sollid, MD, PhD Norwegian Air Ambulance Foundation
Principal Investigator: Geir A Sunde, MD Norwegian Air Ambulance Foundation
  More Information

No publications provided

Responsible Party: Norwegian Air Ambulance Foundation
ClinicalTrials.gov Identifier: NCT01502111     History of Changes
Other Study ID Numbers: NLA-3104-01/02
Study First Received: December 22, 2011
Last Updated: May 7, 2013
Health Authority: Norway: Data Protection Authority

Keywords provided by Norwegian Air Ambulance Foundation:
decreased level of consciousness
hypoxemia
ineffective ventilation
airway obstruction
combative or unresponsive
relief of pain or distress
cardiopulmonary arrest

Additional relevant MeSH terms:
Emergencies
Heart Arrest
Disease Attributes
Pathologic Processes
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 18, 2014