NCT02450071

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
2,028

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2015

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

Study Start

First participant enrolled

May 1, 2015

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

May 7, 2015

Completed
14 days until next milestone

First Posted

Study publicly available on registry

May 21, 2015

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2016

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

August 22, 2017

Status Verified

August 1, 2017

Enrollment Period

1.5 years

First QC Date

May 7, 2015

Last Update Submit

August 21, 2017

Conditions

Cardiac ArrestTraumaTraumatic Brain InjuryHypoventilationAirway ObstructionEmergencies

Keywords

Pre-hospitalOut-of-hospitalPrehospital emergency care (MeSH)Emergency medical services (MeSH)Helicopter emergency medical serviceCritical care (MeSH)Airway management (MeSH)Endotracheal intubation (MeSH)Difficult endotracheal intubationComplications (MeSH)Patient safety

Outcome Measures

Primary Outcomes (1)

  • PHETI ≤ 2attempts and no complications

    Prehospital Endotracheal Intubation success and complications as defined by Sollid et al (Sollid SJ, Lockey D, Lossius HM: A consensus-based template for uniform reporting of data from pre-hospital advanced airway management. Scand J Trauma Resusc Emerg Med 2009, 17:58.)

    At hospital admission (</= 1 day)

Secondary Outcomes (10)

  • PHETI overall success rate

    At hospital admission (</= 1 day)

  • PHETI success on 1st attempt and no complications

    At hospital admission (</= 1 day)

  • PHETI success rate on 1st, 2nd, 3rd and >3rd attempt

    At hospital admission (</= 1 day)

  • PHAAM Complications

    At hospital admission (</= 1 day)

  • Success rate of airway back-up devices

    At hospital admission (</= 1 day)

  • +5 more secondary outcomes

Eligibility Criteria

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

You may qualify if:

  • 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

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)

HEMS VGR

Gothenburg, VästraGötaland, Sweden

Location

MeSH Terms

Conditions

Heart ArrestWounds and InjuriesBrain Injuries, TraumaticHypoventilationAirway ObstructionEmergencies

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesBrain InjuriesBrain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemRespiratory InsufficiencyRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsDisease AttributesPathologic Processes

Study Officials

  • Hans Morten Lossius, MD, PhD

    Norwegian Air Ambulance Foundation

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 7, 2015

First Posted

May 21, 2015

Study Start

May 1, 2015

Primary Completion

November 1, 2016

Study Completion

March 1, 2017

Last Updated

August 22, 2017

Record last verified: 2017-08

Locations

SE(1)