Clinical trial NCT02450071: Pre-Hospital Advanced Airway Management in the Nordic Countries
Official title: Pre-Hospital Advanced Airway Management in the Nordic Countries - A Prospective Multicentre Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cardiac Arrest
Trauma
Traumatic Brain Injury
Hypoventilation
Airway Obstruction
Emergencies
Keywords: Pre-hospital
Out-of-hospital
Prehospital emergency care (MeSH)
Emergency medical services (MeSH)
Helicopter emergency medical service
Critical care (MeSH)
Airway management (MeSH)
Endotracheal intubation (MeSH)
Difficult endotracheal intubation
Complications (MeSH)
Patient safety
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Norwegian Air Ambulance Foundation
First posted: 2015-05-21
Enrollment: 2028
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: All patients requiring prehospital advanced airway management (PHAAM) by the Helicopter Emergency Medical Services (EMS) and Ground EMS (GEMS) units in the study. PHAAM includes endotracheal intubation, supraglottic airway and percutaneous/surgical airway.

Brief summary: Pre-Hospital Advanced Airway Management (PHAAM) is a potentially lifesaving intervention. A recent Danish multicentre single country study demonstrated a 99,7% incidence of successful anaesthesiologist pre-hospital endotracheal intubation, with a PHAAM-related complication rate of 7.9%. A London study revealed a significantly higher intubation failure rate among non-anaesthesiologist physicians. In Scandinavia different types of emergency medical services (EMS) and professions provide PHAAM. The success rate of prehospital endotracheal intubation (PHETI), incidence of difficult intubation and complications in the Nordic countries is not known. The aim of this study is to define PHAAM success rate and complications in different types of Nordic EMS organisations and physician critical care teams. The study is a prospective observational study with collection of PHAAM data according to the template by Sollid et al. in the 12 participating Nordic Countries EMS/HEMS centres and physician critical care teams. The primary endpoint is PHETI success on ≤2 attempts and no complications.

Detailed description: Pre-Hospital Advanced Airway Management (PHAAM) is a potentially lifesaving intervention. A recent meta-analysis of \>15.000 patients reported a variation in the prehospital endotracheal intubation (PHETI) success rate with different methods used and provider background. A recent prehospital study from London revealed a significantly higher intubation failure rate among non-anaesthesiologist physicians. In Scandinavia different types of emergency medical services (EMS) and professionals provide PHAAM. The success rate of PHETI, incidence of difficult intubation and complications in the Nordic countries is not known. Although the EMS structure in Scandinavia is reasonably similar, there are some inter- and intra-national differences regarding mission profile, staffing, systems for dispatch and on-scene management. A Danish PHAAM study demonstrated a 99,7% anaesthesiologist PHETI success rate with a 7,9% complication rate. The authors concluded the study was from a homogenous Danish system limiting the ability to generalise the findings to other systems with different staffing, caseload or case mix.

The PHAST investigators aim to provide prospective multicentre data on the pre-hospital intubation success rate and complications in the Nordic countries. Additionally the investigators will compare the PHAAM procedure for different subgroups of patients, regions and EMS organisations.

In the PHAST observational study twelve Nordic (Sweden, Norway, Denmark and Finland) Helicopter and Rapid Response Emergency Medical Services will include patients during 18 months. The decision to perform PHAAM is based on the discretion of prehospital provider. The PHAAM core data will be prospectively collected according the template by Sollid et al.

The primary endpoint is PHETI success on ≤2 attempts and no complications. Secondary endpoints include overall PHETI success rate, PHETI success on 1st, 2nd, 3rd and \>3rd attempt, difficult PHETI, success rate of laryngeal mask and surgical airway, PHAAM complications and prehospital mortality.

Through predefined analysis of the data, the PHAST investigators hope to

1. Describe the characteristics and outcome of advanced prehospital 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.

Eligibility criteria: Inclusion Criteria:

All patients requiring prehospital advanced airway management (PHAAM) by the Helicopter Emergency Medical Services (EMS) and Ground EMS (GEMS) units in the study. PHAAM includes endotracheal intubation, supraglottic airway and percutaneous/surgical airway. The indications for performing PHAAM as categorised by Sollid et al. are

* Decreased level of consciousness
* Hypoxemia
* Ineffective ventilation
* Existing airway obstruction
* Impending airway obstruction
* Combative or uncooperative patient
* Relief of pain or distress
* Cardiopulmonary arrest
* Other

Exclusion Criteria:

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

Primary outcomes:
measure: PHETI ≤ 2attempts and no complications
timeFrame: At hospital admission (</= 1 day)
Secondary outcomes:
measure: PHETI overall success rate
timeFrame: At hospital admission (</= 1 day)
measure: PHETI success on 1st attempt and no complications
timeFrame: At hospital admission (</= 1 day)
measure: PHETI success rate on 1st, 2nd, 3rd and >3rd attempt
timeFrame: At hospital admission (</= 1 day)
measure: PHAAM Complications
timeFrame: At hospital admission (</= 1 day)
measure: Success rate of airway back-up devices
timeFrame: At hospital admission (</= 1 day)
measure: Pre-hospital mortality
timeFrame: At hospital admission (</= 1 day)
measure: Other pre-specified endpoints and analysis as defined by the ERB-submitted protocol
timeFrame: At hospital admission (</= 1 day)
measure: Mortality
timeFrame: At hospital discharge (estimated average 7 days)
measure: Mortality
timeFrame: At 30 days
measure: PHETI ≤ 2attempts and no complications among patients with TBI
timeFrame: At hospital discharge (estimated average 7 days)
Other outcomes:
Locations:
city: Gothenburg
country: Sweden
facility: HEMS VGR
state: VästraGötaland
Study officials:
affiliation: Norwegian Air Ambulance Foundation
name: Hans Morten Lossius, MD, PhD
role: STUDY_CHAIR
References: