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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
RWTH Aachen University
ClinicalTrials.gov Identifier:
NCT01644045
First received: July 12, 2012
Last updated: August 22, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention
Asthma
COPD
Device: Teleconsultation

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Prehospital Emergency Care of Obstructive Respiratory Emergencies With the Use of Teleconsultation

Resource links provided by NLM:


Further study details as provided by RWTH Aachen University:

Primary Outcome Measures:
  • Oxygen Saturation [ Time Frame: average 1 hour ] [ Designated as safety issue: No ]
    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 [ Time Frame: average 1 hour ] [ Designated as safety issue: No ]
    Analysis of the quality of prehospital care on the basis of published guidelines for asthma / COPD.

  • Rate of ventilation [ Time Frame: average 1 hour ] [ Designated as safety issue: No ]
    Fraction of patients that receive invasive or non-invasive ventilation during the prehospital phase

  • Rate of complications [ Time Frame: 2 hours ] [ Designated as safety issue: No ]
    Rate of complications due to medications: allergic reaction, heart rhythm problems


Estimated Enrollment: 100
Study Start Date: August 2012
Estimated Study Completion Date: March 2014
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Device: Teleconsultation
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
Teleconsultation for the EMS in acute respiratory emergencies

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01644045

Locations
Germany
University Hospital Aachen
Aachen, Germany, 52074
Sponsors and Collaborators
RWTH Aachen University
Investigators
Study Chair: Rolf Rossaint, Prof. Dr. University Hospital Aachen, Germany, Department of Anesthesiology
Principal Investigator: Jörg C Brokmann, Dr. University Hospital Aachen, Germany, Emergency Department
  More Information

No publications provided

Responsible Party: RWTH Aachen University
ClinicalTrials.gov Identifier: NCT01644045     History of Changes
Other Study ID Numbers: 005-1003-0034-4, PtJ-Az.: z0909im002b
Study First Received: July 12, 2012
Last Updated: August 22, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by RWTH Aachen University:
Asthma
COPD
emergency medical service
teleconsultation
telemedicine

Additional relevant MeSH terms:
Emergencies
Disease Attributes
Pathologic Processes

ClinicalTrials.gov processed this record on September 18, 2014