Ignite Creation Date:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2025-12-25 @ 2:04 PM
Study NCT ID:
NCT04206566
Status:
COMPLETED
Last Update Posted:
2021-12-01
First Post:
2019-12-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Pre-hospital Advanced Airway Management Studying Expedited Routines
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-04-11', 'releaseDate': '2023-10-17'}], 'estimatedResultsFirstSubmitDate': '2023-10-17'}}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 430}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-11', 'completionDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-11-30', 'studyFirstSubmitDate': '2019-12-18', 'studyFirstSubmitQcDate': '2019-12-18', 'lastUpdatePostDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'First pass success rate on prehospital tracheal intubation', 'timeFrame': 'While handling the patient in need for tracheal intubation', 'description': 'Successful intubation is defined as the endotracheal tube verified in the trachea. Prehospital intubations are performed outside the hospitals by ambulance helicopter personnel.'}], 'secondaryOutcomes': [{'measure': 'Tracheal intubation performed outside or in-cabin (in helicopter or in ambulance)', 'timeFrame': 'While handling the patient case', 'description': 'The location of the procedure'}, {'measure': 'Number of tracheal intubation attempts', 'timeFrame': 'While handling the patient case'}, {'measure': 'Perceived difficulty of tracheal intubation', 'timeFrame': 'While handling the patient case', 'description': 'Measured on a numeric analogue scale'}, {'measure': 'Time to perform tracheal intubation', 'timeFrame': 'While handling the patient case', 'description': 'Time from first passing teeth with laryngoscope to tube verification with ETCO2 and lung auscultation.'}, {'measure': 'Complications related to the drug assisted intubation', 'timeFrame': 'While handling the patient case'}, {'measure': 'Prehospital mortality', 'timeFrame': 'While handling the patient case'}, {'measure': 'Scene time 1', 'timeFrame': 'While handling the patient case', 'description': 'Measured from entering patient zone (\\<3 m) to starting to move the patient from the scene to the helicopter (if intubation in-ambulance, time from entering patient zone until starting to move the patient to the helicopter).'}, {'measure': 'Scene time 2', 'timeFrame': 'While handling the patient case', 'description': 'Measured from entering patient zone (\\<3 m) to declaring pilot can switch on helicopter motors.'}, {'measure': 'Ground time', 'timeFrame': 'While handling the patient case', 'description': 'Mesaured from physician leaves helicopter to declaring pilot can switch on helicopter motors.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Emergency Medicine', 'Airway Management', 'Intubation']}, 'referencesModule': {'references': [{'pmid': '41291842', 'type': 'DERIVED', 'citation': 'Broms J, Gunther M, Svensen C, Kruger A, Rognas L, Gellerfors M. The impact of airway assistants on prehospital endotracheal intubations - a subgroup analysis of data from anaesthesiologist-staffed helicopter critical care teams. Scand J Trauma Resusc Emerg Med. 2025 Nov 25. doi: 10.1186/s13049-025-01515-y. Online ahead of print.'}, {'pmid': '37845108', 'type': 'DERIVED', 'citation': 'Broms J, Linhardt C, Fevang E, Helliksson F, Skallsjo G, Haugland H, Knudsen JS, Bekkevold M, Tvede MF, Brandenstein P, Hansen TM, Kruger A, Rognas L, Lossius HM, Gellerfors M. Prehospital tracheal intubations by anaesthetist-staffed critical care teams: a prospective observational multicentre study. Br J Anaesth. 2023 Dec;131(6):1102-1111. doi: 10.1016/j.bja.2023.09.013. Epub 2023 Oct 14.'}]}, 'descriptionModule': {'briefSummary': 'In the Scandinavian and Swiss HEMS critical care teams, the prehospital tracheal intubations (TI) are performed by airway experts with high success rates and low rates of complications. Due to environmental conditions these are today frequently performed in-cabin before take-off. There are so far no published data on comparing outside and in-cabin TI under these circumstances.\n\nThis will therefore be the first prospective study comparing prehospital TIs outside or incabin, performed by airway experts.', 'detailedDescription': "Background Seriously ill or injured patients might require prehospital TI, which is a potentially lifesaving intervention. Performing TI in a prehospital context differ from the preconditions inhospital due to environmental and technical aspects and resources available (3). Today there is a consensus that prehospital critical care should at least be on the same standards as in-hospital care. The trend therefore has been towards more rigorous safety precautions introducing Standard Operating Procedures (SOP) including 360oaccess to patients with all equipment at close hand brought out from the helicopter or the ambulance and long challenge-response lists. This will shift focus towards adherence to SOPs instead of tailoring the sequence of procedures according to circumstances and patient needs. An experienced operator can plan and communicate appropriate actions from a risk-benefit perspective in a stressful situation. Prehospital interventions have to be time effective, especially where short on-scene times are preferable in time-critical conditions such as uncontrolled internal haemorrhage and traumatic brain injuries.\n\nA recent Nordic multicentre study, PHAST, shows that emergency systems staffed with highly experienced anaesthetists can perform prehospital TI with high success rates, low incidence of complications and short on-scene times. Due to environmental factors, weather and light conditions in the Scandinavian countries, it is not always favourable to perform TI outside the helicopter or ambulance, with 360o -access. Technical aspects in-helicopter/in-ambulance such as access to better suctioning and stretcher positioning, can influence the operator's decision on where to perform the TI. Whether the location of the TI affects the outcome has not yet been studied. A recent experimental mannequin study, SPRINT, suggests that in-cabin intubations can offer equal to, or even better conditions than out of cabin and can shorten on-scene time. To investigate whether this applies to real life conditions, a prospective large-scale clinical study must be done.\n\nPerforming prehospital TI is dependent on a well-functioning team where the operator has an assistant backing up during the procedures. The assistants' level of airway experience and the teams' accumulated experience working together has not been studied earlier."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'All drug-assisted intubations performed at the participating HEMSorganizations between 01/01/2020 and 01/09/2021.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients in need of prehospital drug-assisted intubation.\n\nExclusion Criteria:\n\n* All cases where prehospital TI is performed without the use of any drugs.'}, 'identificationModule': {'nctId': 'NCT04206566', 'acronym': 'PHASTER', 'briefTitle': 'Pre-hospital Advanced Airway Management Studying Expedited Routines', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'PHASTER - Pre-Hospital Advanced Airway Management STudying Expedited Routines', 'orgStudyIdInfo': {'id': 'PHASTER-01'}}, 'contactsLocationsModule': {'locations': [{'city': 'Mora', 'state': 'Dalarna County', 'country': 'Sweden', 'facility': 'HEMS Dalarna', 'geoPoint': {'lat': 61.00704, 'lon': 14.54316}}, {'city': 'Gothenburg', 'state': 'VästraGötaland', 'country': 'Sweden', 'facility': 'HEMS VGR', 'geoPoint': {'lat': 57.70716, 'lon': 11.96679}}], 'overallOfficials': [{'name': 'Mikael Gellerfors', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'A PMI, Karolinska University Hospital, Stockholm'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'CSR'], 'timeFrame': 'From 2022', 'ipdSharing': 'YES', 'description': 'All collected IPD'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Research & Development, Swedish Air Ambulance (SLA)', 'investigatorFullName': 'Mikael Gellerfors', 'investigatorAffiliation': 'Karolinska Institutet'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2023-10-17', 'type': 'RELEASE'}, {'date': '2024-04-11', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Mikael Gellerfors, Head of Research & Development, Swedish Air Ambulance (SLA), Karolinska Institutet'}}}}