NCT01502111

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,333

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 22, 2011

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 30, 2011

Completed
2 days until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
Last Updated

May 8, 2013

Status Verified

May 1, 2013

Enrollment Period

1.2 years

First QC Date

December 22, 2011

Last Update Submit

May 7, 2013

Conditions

Keywords

decreased level of consciousnesshypoxemiaineffective ventilationairway obstructioncombative or unresponsiverelief of pain or distresscardiopulmonary arrest

Outcome Measures

Primary Outcomes (1)

  • Number of participants who survive to hospital admission

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

Secondary Outcomes (1)

  • Number of participants with adverse events during airway interventions

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

Study Arms (1)

Airway management

Patients receiving advanced airway management in physician manned helicopter emergency medical services over a 12-month period.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability 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

You may qualify if:

  • 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

You may not qualify if:

  • Patients receiving advanced airway management during so-called secondary missions (or inter-hospital transfer).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Research and Development, Norwegian Air Ambulance Foundation

Drøbak, Drøbak, 1441, Norway

Location

Related Publications (2)

  • 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.

MeSH Terms

Conditions

Wounds and InjuriesHeart ArrestEmergenciesHypoxiaAirway Obstruction

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms, RespiratorySigns and SymptomsRespiratory InsufficiencyRespiration DisordersRespiratory Tract Diseases

Study Officials

  • Stephen Sollid, MD, PhD

    Norwegian Air Ambulance Foundation

    STUDY CHAIR
  • Geir A Sunde, MD

    Norwegian Air Ambulance Foundation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 22, 2011

First Posted

December 30, 2011

Study Start

January 1, 2012

Primary Completion

March 1, 2013

Study Completion

March 1, 2013

Last Updated

May 8, 2013

Record last verified: 2013-05

Locations