NCT01644045

Brief Summary

The aim of the study is to investigate the quality of prehospital emergency care in acute respiratory emergencies, when paramedics are supported telemedically by an EMS physician.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
17

participants targeted

Target at below P25 for not_applicable asthma

Timeline
Completed

Started Aug 2012

Typical duration for not_applicable asthma

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 12, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

July 18, 2012

Completed
14 days until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2013

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
Last Updated

September 22, 2015

Status Verified

September 1, 2015

Enrollment Period

11 months

First QC Date

July 12, 2012

Last Update Submit

September 21, 2015

Conditions

Keywords

AsthmaCOPDemergency medical serviceteleconsultationtelemedicine

Outcome Measures

Primary Outcomes (1)

  • Oxygen Saturation

    Measurement of pulse oximetric oxygen saturation at the timepoint of first contact with a physician (EMS physician OR hospital arrival)

    average 1 hour

Secondary Outcomes (3)

  • Quality of emergency care

    average 1 hour

  • Rate of ventilation

    average 1 hour

  • Rate of complications

    2 hours

Study Arms (1)

Device: Teleconsultation

EXPERIMENTAL

In cases of acute obstructive, respiratory emergencies if patients give informed consent the paramedics can use this system to contact a so called "tele-EMS physician" who has an audio-connection to the EMS team and receives vital parameters (e.g., ECG, pulse oximetry, non-invasive blood pressure) in real-time. The transmission of still pictures (taken with a smartphone), 12-lead-ECGs and video streaming from the inside of the ambulance can also be carried out, if indicated. The tele-EMS physician supports the EMS team in obtaining all relevant medical history, diagnosis and can delegate the application of medications. This can be carried out to bridge the time to the arrival of an EMS physician or in less severe cases without an EMS physician on-scene. The quality of prehospital care and the possible influences on the initial inhospital phase should be investigated and compared with regular EMS.

Device: Teleconsultation

Interventions

Teleconsultation for the EMS in acute respiratory emergencies

Device: Teleconsultation

Eligibility Criteria

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

You may qualify if:

  • Obstructive, respiratory emergency
  • Verbal consent for teleconsultation obtained or patient is not able to consent due the severity of the emergency

You may not qualify if:

  • No respiratory emergency
  • Refused consent for teleconsultation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Aachen

Aachen, 52074, Germany

Location

MeSH Terms

Conditions

AsthmaPulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Rolf Rossaint, Prof. Dr.

    University Hospital Aachen, Germany, Department of Anesthesiology

    STUDY CHAIR
  • Jörg C Brokmann, Dr.

    University Hospital Aachen, Germany, Emergency Department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 12, 2012

First Posted

July 18, 2012

Study Start

August 1, 2012

Primary Completion

July 1, 2013

Study Completion

September 1, 2015

Last Updated

September 22, 2015

Record last verified: 2015-09

Locations