NCT00212953

Brief Summary

The purpose of the study is to evaluate the incremental benefit of a full advanced life support EMS program on the outcomes of chest pain, respiratory and major trauma patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
21,000

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 1997

Typical duration for not_applicable

Geographic Reach
1 country

11 active sites

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

March 1, 1997

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 1999

Completed
6.4 years until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
8 days until next milestone

First Posted

Study publicly available on registry

September 21, 2005

Completed
Last Updated

October 15, 2010

Status Verified

October 1, 2010

First QC Date

September 13, 2005

Last Update Submit

October 13, 2010

Conditions

Keywords

Chest Pain,Shortness of breath,Injury,Trauma

Outcome Measures

Primary Outcomes (1)

  • Survival to discharge

Secondary Outcomes (8)

  • Generic Quality of Life

  • Disease Specific Quality of Life CPC Score and FIM Score

  • Performance of ALS Procedures

  • Response Time Intervals

  • Length of Stay in Hospital

  • +3 more secondary outcomes

Interventions

Eligibility Criteria

Age16 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Chest Pain Sub-Study: Adult patients with a complaint of chest pain of an acute nature transported to hospital by ambulance. Patients with a complaint of pain in arms, neck or jaw if consistent with myocardial ischemia. Patients must have an ambulance return code of prompt, urgent, or no patient carried.
  • Respiratory Sub-Study: Adult patients with a chief complaint of shortness of breath defined as ACR codes of Respiratory Failure, Shortness of Breath NYD, Pulmonary Edema (CHF), Asthma and had either prehospital assisted ventilation or abnormal respiratory rates (\>=24 or \<=10)
  • Major Trauma Sub-Study: Adult patients who have suffered an injury from any mechanism with an Injury Severity Score of \>12 who have been transported to hospital by land ambulance, and who have been entered into the Ontario Trauma Registry (OTR) Comprehensive Data Set.

You may not qualify if:

  • All Sub-Studies:
  • Patients under the age of 16
  • Patients who are vital signs absent prior to EMS arrival.
  • Chest Pain Sub-Study:
  • Patients suffering primarily from respiratory distress, respiratory failure, pulmonary edema, asthma, palpitations or epigastric pain. pain

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (11)

Cambridge Base Hospital

Cambridge, Ontario, N3C 3X4, Canada

Location

Sudbury Base Hospital

Greater Sudbury, Ontario, 705-675-4783, Canada

Location

Kingston Base Hospital

Kingston, Ontario, K7L 1S4, Canada

Location

London Base Hospital

London, Ontario, N6A 4G5, Canada

Location

Halton Base Hospital

Mississauga, Ontario, L6K 3S3, Canada

Location

Niagara Falls Base Hospital

Niagara Falls, Ontario, L2E 6X2, Canada

Location

Ottawa Base Hospital

Ottawa, Ontario, K1H 8L6, Canada

Location

Peterborough Base Hospital

Peterborough, Ontario, K9J 7C6, Canada

Location

Lambton Base Hospital

Sarnia, Ontario, N7T 6S3, Canada

Location

Thunder Bay Base Hospital

Thunder Bay, Ontario, P7E 1G6, Canada

Location

Windsor Base Hospital

Windsor, Ontario, N9A 1E1, Canada

Location

MeSH Terms

Conditions

Heart ArrestChest PainDyspneaWounds and Injuries

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsRespiration DisordersRespiratory Tract DiseasesSigns and Symptoms, Respiratory

Study Officials

  • Ian Stiell, MD

    OHRI

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 13, 2005

First Posted

September 21, 2005

Study Start

March 1, 1997

Study Completion

May 1, 1999

Last Updated

October 15, 2010

Record last verified: 2010-10

Locations