NCT02307123

Brief Summary

The primary aim of this study was to describe the long-term outcome of critically ill or severely injured patients not in cardiac arrest treated by an EMS physician.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
483

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2013

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

January 1, 2013

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2014

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2014

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 4, 2014

Completed
2.1 years until next milestone

Results Posted

Study results publicly available

December 22, 2016

Completed
Last Updated

December 22, 2016

Status Verified

December 1, 2015

Enrollment Period

1 year

First QC Date

November 30, 2014

Results QC Date

December 2, 2015

Last Update Submit

October 27, 2016

Conditions

One-year Outcome After Prehospital Intubation

Keywords

Prehospital emergency care (MeSH)Emergency medical services (MeSH)Helicopter emergency medical service, Critical care (MeSH)Airway management (MeSH)Endotracheal intubation (MeSH)Patient outcome

Outcome Measures

Primary Outcomes (1)

  • Mortality

    1 year

Secondary Outcomes (1)

  • Glasgow Outcome Score (GOS)

    1 year

Study Arms (1)

HEMS treated patients

Patients whose airways were secured by the HEMS physician.

Procedure: Intubation

Interventions

IntubationPROCEDURE

HEMS physician prehospital intubation

HEMS treated patients

Eligibility Criteria

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

All non-cardiac arrest patients, whose airway was secured by the HEMS physician.

You may qualify if:

  • All non-cardiac arrest patients.

You may not qualify if:

  • Patients with a known need for personal assistance in activities of daily life prior to the incident leading to prehospital intubation (outcome evaluation).
  • Patients intubated by EMS before HEMS arrival.
  • Death on scene or during transportation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Interventions

Intubation

Intervention Hierarchy (Ancestors)

TherapeuticsInvestigative Techniques

Results Point of Contact

Title
Toni Pakkanen, MD
Organization
Tampere University Hospital
toni.pakkanen@icloud.com
358408227209

Study Officials

  • Arvi Yli-Hankala, professor

    Tampere University Hospital

    STUDY DIRECTOR

  • Toni VS Pakkanen, MD

    Tampere University Hospital

    PRINCIPAL INVESTIGATOR

  • Ilkka Virkkunen, MD, PhD

    Tampere University Hospital

    STUDY CHAIR

  • Tom Silfvast, MD, PhD

    Helsinki University Central Hospital

    STUDY CHAIR

  • Tarja Randell, MD, PhD

    Helsinki University Central Hospital

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

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

Study Record Dates

First Submitted

November 30, 2014

First Posted

December 4, 2014

Study Start

January 1, 2013

Primary Completion

January 1, 2014

Study Completion

April 1, 2014

Last Updated

December 22, 2016

Results First Posted

December 22, 2016

Record last verified: 2015-12