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Completed

NCT Number: NCT04206566

Pre-hospital Advanced Airway Management Studying Expedited Routines

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.

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Key information

Sex eligibility

All sexes

Study type

Observational

Primary location

HEMS Dalarna, Mora, Dalarna County, Sweden

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. First pass success rate on prehospital tracheal intubation

    Time frame: 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 outcomes

  1. Tracheal intubation performed outside or in-cabin (in helicopter or in ambulance)

    Time frame: While handling the patient case

    The location of the procedure

  2. Number of tracheal intubation attempts

    Time frame: While handling the patient case

  3. Perceived difficulty of tracheal intubation

    Time frame: While handling the patient case

    Measured on a numeric analogue scale

  4. Time to perform tracheal intubation

    Time frame: 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

    Time frame: While handling the patient case

  6. Prehospital mortality

    Time frame: While handling the patient case

  7. Scene time 1

    Time frame: 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

    Time frame: While handling the patient case

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

  9. Ground time

    Time frame: While handling the patient case

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

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Registry information

Official study title

PHASTER - Pre-Hospital Advanced Airway Management STudying Expedited Routines

Acronym: PHASTER

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Dec 20, 2019
Registry last updated
Dec 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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