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Prehospital Emergency Care of Obstructive Respiratory Emergencies With the Use of Teleconsultation

Primary Purpose

Asthma, COPD

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Teleconsultation
Sponsored by
RWTH Aachen University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, COPD, emergency medical service, teleconsultation, telemedicine

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

  • No respiratory emergency
  • Refused consent for teleconsultation

Sites / Locations

  • University Hospital Aachen

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Device: Teleconsultation

Arm Description

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Quality of emergency care
Analysis of the quality of prehospital care on the basis of published guidelines for asthma / COPD.
Rate of ventilation
Fraction of patients that receive invasive or non-invasive ventilation during the prehospital phase
Rate of complications
Rate of complications due to medications: allergic reaction, heart rhythm problems

Full Information

First Posted
July 12, 2012
Last Updated
September 21, 2015
Sponsor
RWTH Aachen University
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1. Study Identification

Unique Protocol Identification Number
NCT01644045
Brief Title
Prehospital Emergency Care of Obstructive Respiratory Emergencies With the Use of Teleconsultation
Official Title
Prehospital Emergency Care of Obstructive Respiratory Emergencies With the Use of Teleconsultation
Study Type
Interventional

2. Study Status

Record Verification Date
September 2015
Overall Recruitment Status
Completed
Study Start Date
August 2012 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
September 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RWTH Aachen University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
Detailed Description
Six ambulances from five different Emergency Medical Service (EMS) districts are equipped with a portable telemedicine system. In cases of acute obstructive, respiratory emergencies the paramedics can use this system to contact a so called "tele-EMS physician" after consent of the patient was obtained. The tele-EMS physician 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma, COPD
Keywords
Asthma, COPD, emergency medical service, teleconsultation, telemedicine

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Device: Teleconsultation
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Teleconsultation
Intervention Description
Teleconsultation for the EMS in acute respiratory emergencies
Primary Outcome Measure Information:
Title
Oxygen Saturation
Description
Measurement of pulse oximetric oxygen saturation at the timepoint of first contact with a physician (EMS physician OR hospital arrival)
Time Frame
average 1 hour
Secondary Outcome Measure Information:
Title
Quality of emergency care
Description
Analysis of the quality of prehospital care on the basis of published guidelines for asthma / COPD.
Time Frame
average 1 hour
Title
Rate of ventilation
Description
Fraction of patients that receive invasive or non-invasive ventilation during the prehospital phase
Time Frame
average 1 hour
Title
Rate of complications
Description
Rate of complications due to medications: allergic reaction, heart rhythm problems
Time Frame
2 hours

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Obstructive, respiratory emergency Verbal consent for teleconsultation obtained or patient is not able to consent due the severity of the emergency Exclusion Criteria: No respiratory emergency Refused consent for teleconsultation
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Rolf Rossaint, Prof. Dr.
Organizational Affiliation
University Hospital Aachen, Germany, Department of Anesthesiology
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Jörg C Brokmann, Dr.
Organizational Affiliation
University Hospital Aachen, Germany, Emergency Department
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Aachen
City
Aachen
ZIP/Postal Code
52074
Country
Germany

12. IPD Sharing Statement

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Prehospital Emergency Care of Obstructive Respiratory Emergencies With the Use of Teleconsultation

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