PHASTER: Pre-hospital Advanced Airway Management Studying Expedited Routines

Sponsor
Karolinska Institutet (Other)
Overall Status
Completed
CT.gov ID
NCT04206566
Collaborator
(none)
430
2
18
215
11.9

Study Details

Study Description

Brief Summary

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.

This will therefore be the first prospective study comparing prehospital TIs outside or incabin, performed by airway experts.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    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.

    A 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.

    Performing 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.

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    430 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    PHASTER - Pre-Hospital Advanced Airway Management STudying Expedited Routines
    Actual Study Start Date :
    Mar 1, 2020
    Actual Primary Completion Date :
    Sep 1, 2021
    Actual Study Completion Date :
    Sep 1, 2021

    Outcome Measures

    Primary Outcome Measures

    1. First pass success rate on prehospital tracheal intubation [While handling the patient in need for tracheal intubation]

      Successful intubation is defined as the endotracheal tube verified in the trachea. Prehospital intubations are performed outside the hospitals by ambulance helicopter personnel.

    Secondary Outcome Measures

    1. Tracheal intubation performed outside or in-cabin (in helicopter or in ambulance) [While handling the patient case]

      The location of the procedure

    2. Number of tracheal intubation attempts [While handling the patient case]

    3. Perceived difficulty of tracheal intubation [While handling the patient case]

      Measured on a numeric analogue scale

    4. Time to perform tracheal intubation [While handling the patient case]

      Time from first passing teeth with laryngoscope to tube verification with ETCO2 and lung auscultation.

    5. Complications related to the drug assisted intubation [While handling the patient case]

    6. Prehospital mortality [While handling the patient case]

    7. Scene time 1 [While handling the patient case]

      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).

    8. Scene time 2 [While handling the patient case]

      Measured from entering patient zone (<3 m) to declaring pilot can switch on helicopter motors.

    9. Ground time [While handling the patient case]

      Mesaured from physician leaves helicopter to declaring pilot can switch on helicopter motors.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:
    • Patients in need of prehospital drug-assisted intubation.
    Exclusion Criteria:
    • All cases where prehospital TI is performed without the use of any drugs.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 HEMS Dalarna Mora Dalarna Sweden
    2 HEMS VGR Gothenburg VästraGötaland Sweden

    Sponsors and Collaborators

    • Karolinska Institutet

    Investigators

    • Principal Investigator: Mikael Gellerfors, A PMI, Karolinska University Hospital, Stockholm

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Mikael Gellerfors, Head of Research & Development, Swedish Air Ambulance (SLA), Karolinska Institutet
    ClinicalTrials.gov Identifier:
    NCT04206566
    Other Study ID Numbers:
    • PHASTER-01
    First Posted:
    Dec 20, 2019
    Last Update Posted:
    Dec 1, 2021
    Last Verified:
    Nov 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Dec 1, 2021