TraumaAIRPORTNCT01502111
Airway Management Study in Physician Manned Helicopter Emergency Medical Services
An observational study of Trauma and Cardiac Arrest, run by Norwegian Air Ambulance Foundation at 1 site in Norway.
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… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Trauma, Cardiac Arrest, Emergencies
- How many people
- 2,333 participants
- Where
- 1 siteNorway
- Study dates
- Jan 2012to Mar 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Patients receiving advanced airway management during so-called secondary missions (or inter-hospital transfer).
Trial locations and contacts
1 site in 1 country.
Norway1 site
Department of Research and Development, Norwegian Air Ambulance Foundation
Drøbak, Drøbak, 1441
About this study
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
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.
Read the 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:
- 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.
- Conditions
- Trauma, Cardiac Arrest, Emergencies
- Keywords
- decreased level of consciousness, hypoxemia, ineffective ventilation, airway obstruction, combative or unresponsive, relief of pain or distress, cardiopulmonary arrest
- Medical subject headings
- Wounds and Injuries, Heart Arrest, Emergencies, Hypoxia, Airway Obstruction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Airway management | Patients receiving advanced airway management in physician manned helicopter emergency medical services over a 12-month period. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who survive to hospital admission
Measured: Time from injury/illness to admission hospital, up to 24 hours
Secondary outcomes (1)
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.
Measured: Time from injury/illness to admission hospital, up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2011 (estimated)
- Study startJan 2012
- Primary completionMar 2013
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for TraumaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 2,333 participants (actual)
Sponsor and investigators
- Lead sponsor
- Norwegian Air Ambulance Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- Haukeland University Hospital
- Responsible party
- Sponsor
- Investigators
- Stephen Sollid, MD, PhD, Study chair, Norwegian Air Ambulance FoundationGeir A Sunde, MD, Principal investigator, Norwegian Air Ambulance Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01502111
- Sponsor's protocol ID
- NLA-3104-01/02
- Acronym
- AIRPORT
- Status last verified
- May 2013
- First submitted
- 22 Dec 2011
- Last updated
- 8 May 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 28693491Sunde 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.
PubMed 26250700
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01502111
- Acronym / sponsor ID
- AIRPORT / NLA-3104-01/02
- Conditions
- Trauma, Cardiac Arrest, Emergencies
- Keywords
- decreased level of consciousness, hypoxemia, ineffective ventilation, airway obstruction, combative or unresponsive, relief of pain or distress, cardiopulmonary arrest
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,333 participants (actual)
- Lead sponsor
- Norwegian Air Ambulance FoundationUniversity, hospital or other
- Collaborators
- Haukeland University Hospital
- Study start
- Jan 2012
- Primary completion
- Mar 2013 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 30 Dec 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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:
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Airway management | – | –Patients receiving advanced airway management in physician manned helicopter emergency medical services over a 12-month period. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (1 listed)
- Patients receiving advanced airway management during so-called secondary missions (or inter-hospital transfer).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of participants who survive to hospital admission
Time frame: Time from injury/illness to admission hospital, up to 24 hours
1 secondary outcome
Number of participants with adverse events during airway interventions
Time frame: Time from injury/illness to admission hospital, up to 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2013.
- Derived from this study: PubMed 28693491Sunde 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.
- Derived from this study: PubMed 26250700Sunde 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Stephen Sollid, MD, PhD study chair
Norwegian Air Ambulance Foundation
Geir A Sunde, MD principal investigator
Norwegian Air Ambulance Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Trauma and Cardiac Arrest, run by Norwegian Air Ambulance Foundation at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 May 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who survive to hospital admission (time frame: Time from injury/illness to admission hospital, up to 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01502111, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2013; AzTrials last refreshed its copy on 7 Nov 2026.