NCT01730001

Brief Summary

This study looks at advanced airway management in critically ill or injured patients treated by physician manned emergency medical services, comparing early (on-scene) intubation to late (emergency department) intubation.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Jan 2015

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
withdrawn

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

November 10, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 21, 2012

Completed
2.1 years until next milestone

Study Start

First participant enrolled

January 1, 2015

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 28, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 28, 2017

Completed
Last Updated

September 19, 2017

Status Verified

September 1, 2017

Enrollment Period

2.2 years

First QC Date

November 10, 2012

Last Update Submit

September 18, 2017

Conditions

TraumaCraniocerebral TraumaIntracerebral HemorrhageSeizuresUnconsciousness

Outcome Measures

Primary Outcomes (2)

  • 30 days mortality after injury or illness.

    Dead or alive

    30 days after illness or injury

  • Neurologic outcome at 6 months after injury or illness.

    Neurologic outcome will be assessed using glascow outcome scores (GOS-E)

    6 months after illness or injury

Secondary Outcomes (3)

  • Intubation success rates and airway management complications for the entire cohort and for key subsets

    up to 6 months after illness or injury

  • Length of hospital stay, complications and degree of disability at discharge.

    up to 6 months after illness or injury

  • Prevalence of adverse effects like cardiovascular complications (e.g. bradycardia, hypotension, asystole), and respiratory complications (e.g. hypoxia, pneumothorax).

    up to 6 months after illness or injury

Study Arms (2)

Early Intubation

ACTIVE COMPARATOR

Early intubation is defined as prehospital intubation on the scene of the patient illness/injury, or where the EMS physician first meets the patient (e.g en route to hospital). Intubation includes drug assisted and/or rapid sequence intubation (RSI) with endotracheal tube.

Procedure: Early Intubation

Late intubation

ACTIVE COMPARATOR

Late intubation is defined as on-scene prehospital high-flow (\> 10 L/min) supplemental oxygen by mask, assisted bag-mask-ventilation by EMS physician if required and stable recovery position during transport to hospital. Intubation should be done on arrival in the emergency department.

Procedure: Late intubation

Interventions

Early IntubationPROCEDURE
Early Intubation
Late intubationPROCEDURE
Late intubation

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patients (\> 18 years)
  • Initial GCS \< 9 independent of cause.
  • Intact airway reflexes and no impending airway obstruction.
  • Located \< 20 min ambulance transport time from nearest hospital emergency department.

You may not qualify if:

  • Pediatric patients (under 18 years).
  • Primary cardiorespiratory arrest (of non-traumatic / medical cause).
  • Planned helicopter transport to hospital.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Haukeland University Hospital

Bergen, 5021, Norway

Location

Norwegian Air Ambulance Foundation

Drøbak, 1441, Norway

Location

Related Links

MeSH Terms

Conditions

Wounds and InjuriesCraniocerebral TraumaCerebral HemorrhageSeizuresUnconsciousness

Condition Hierarchy (Ancestors)

Trauma, Nervous SystemNervous System DiseasesIntracranial HemorrhagesCerebrovascular DisordersBrain DiseasesCentral Nervous System DiseasesVascular DiseasesCardiovascular DiseasesHemorrhagePathologic ProcessesPathological Conditions, Signs and SymptomsNeurologic ManifestationsSigns and SymptomsConsciousness DisordersNeurobehavioral Manifestations

Study Officials

  • Geir A Sunde, MD

    Norwegian Air Ambulance Foundation

    PRINCIPAL INVESTIGATOR

  • Stephen JM Sollid, MD, PhD, Ass.Prof

    Norwegian Air Ambulance Foundation

    STUDY CHAIR

  • Hans M Lossius, MD, PhD, Prof

    Norwegian Air Ambulance Foundation

    STUDY DIRECTOR

  • Espen Fevang, MD

    Norwegian Air Ambulance Foundation

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 10, 2012

First Posted

November 21, 2012

Study Start

January 1, 2015

Primary Completion

March 28, 2017

Study Completion

March 28, 2017

Last Updated

September 19, 2017

Record last verified: 2017-09

Locations

NO(2)