Ignite Creation Date:
2025-12-24 @ 9:28 PM
Ignite Modification Date:
2026-02-20 @ 6:21 PM
Study NCT ID:
NCT01644032
Status:
COMPLETED
Last Update Posted:
2015-09-22
First Post:
2012-07-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Telemedically Supported Analgesia in the Emergency Medical Service
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000377', 'term': 'Agnosia'}, {'id': 'D004630', 'term': 'Emergencies'}], 'ancestors': [{'id': 'D010468', 'term': 'Perceptual Disorders'}, {'id': 'D019954', 'term': 'Neurobehavioral Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019114', 'term': 'Remote Consultation'}], 'ancestors': [{'id': 'D012017', 'term': 'Referral and Consultation'}, {'id': 'D011364', 'term': 'Professional Practice'}, {'id': 'D009934', 'term': 'Organization and Administration'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017216', 'term': 'Telemedicine'}, {'id': 'D003695', 'term': 'Delivery of Health Care'}, {'id': 'D010346', 'term': 'Patient Care Management'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 106}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-21', 'studyFirstSubmitDate': '2012-07-12', 'studyFirstSubmitQcDate': '2012-07-16', 'lastUpdatePostDateStruct': {'date': '2015-09-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of complications', 'timeFrame': '2 hours', 'description': 'Definition of complications: respiratory insufficiency, allergic reaction, circulatory insufficiency'}], 'secondaryOutcomes': [{'measure': 'Pain level', 'timeFrame': 'average 1 hour', 'description': 'Pain level measured with numerical rating scale'}, {'measure': 'Incidence of nausea and vomiting', 'timeFrame': '2 hours'}, {'measure': 'Time intervals', 'timeFrame': 'average 1 hour', 'description': 'on-scene time, contact to hospital time'}, {'measure': 'Medications and dosages', 'timeFrame': 'average 1 hour', 'description': 'Evaluation and description of the used medications and dosages'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['telemedicine', 'teleconsultation', 'analgesia', 'emergency', 'prehospital'], 'conditions': ['Indication for Analgesia', 'Emergency Medical Service', 'Teleconsultation']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to evaluate the safety and efficacy of telemedically supported and delegated pain therapy in the Emergency Medical Service (EMS).', 'detailedDescription': 'Six ambulances from five different Emergency Medical Service (EMS) districts are equipped with a portable telemedicine system. In cases of emergencies, where intravenous analgesia is necessary, the paramedics can use this system to contact a so called "tele-EMS physician" after consent of the patient is 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 - and video streaming from the inside of the ambulance can be carried out, if meaningful. The tele-EMS physician supports the EMS team and can delegate the application of morphine and other analgesics. 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.\n\nAll regular ambulances of the five districts are not allowed to administer analgesics without an physician on-scene. They have to call an Advanced Life Support response unit, staffed with an EMS physician, who carries out all kinds of ALS interventions.\n\nThe safety, efficacy and the quality of analgesia should be compared with regular EMS.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Verbal consent obtained or patient is unable to consent due to the severity of the emergency\n* Indication for analgesia\n\nExclusion Criteria:\n\n* Refused consent\n* No indication for analgesia'}, 'identificationModule': {'nctId': 'NCT01644032', 'briefTitle': 'Telemedically Supported Analgesia in the Emergency Medical Service', 'organization': {'class': 'OTHER', 'fullName': 'RWTH Aachen University'}, 'officialTitle': 'Telemedically Supported Analgesia in the Emergency Medical Service', 'orgStudyIdInfo': {'id': '005-1003-0034-3'}, 'secondaryIdInfos': [{'id': 'PtJ-Az.: z0909im002b', 'type': 'OTHER_GRANT', 'domain': 'PTJ'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Device_ Teleconsultation', 'description': 'Six ambulances from five different Emergency Medical Service (EMS) districts are equipped with a portable telemedicine system. In cases of emergencies, where intravenous analgesia is necessary, if patients give informed consent the paramedics can use this system to contact a so called "tele-EMS physician" with an audio-connection to the EMS team who receives vital parameters (e.g., ECG, pulse oximetry, non-invasive blood pressure) in real-time. The transmission of still pictures - taken with a smartphone - and video streaming from the inside of the ambulance can be carried out, if meaningful. The tele-EMS physician supports the EMS team and can delegate the application of morphine and other analgesics. 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.\n\nThe safety, efficacy and the quality of analgesia should be compared with regular EMS.', 'interventionNames': ['Other: Teleconsultation']}, {'type': 'NO_INTERVENTION', 'label': 'Historical Control Period', 'description': 'After completion of the study arm, matched pairs from a historical phase (without the ability of teleconsultation) were searched. Local cases were always matched with comparable controls from the same location.'}], 'interventions': [{'name': 'Teleconsultation', 'type': 'OTHER', 'description': 'Teleconsultation between paramedics and an EMS physician', 'armGroupLabels': ['Device_ Teleconsultation']}]}, 'contactsLocationsModule': {'locations': [{'zip': '52074', 'city': 'Aachen', 'country': 'Germany', 'facility': 'University Hospital Aachen', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}], 'overallOfficials': [{'name': 'Rolf Rossaint, Prof. Dr.', 'role': 'STUDY_CHAIR', 'affiliation': 'University Hospital Aachen, Germany, Department of Anesthesiology'}, {'name': 'Jörg Brokmann, Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Aachen, Germany, Emergency Department'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'RWTH Aachen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}