Emergency MedicinePHASTERNCT04206566
Pre-hospital Advanced Airway Management Studying Expedited Routines
An observational study of Emergency Medicine and Airway Management, run by Karolinska Institutet at 2 sites in Sweden.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Emergency Medicine, Airway Management, Intubation
- How many people
- 430 participants
- Where
- 2 sitesSweden
- Study dates
- 1 Mar 2020to 1 Sep 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: All drug-assisted intubations performed at the participating HEMSorganizations between 01/01/2020 and 01/09/2021.
Who may be able to join
- Patients in need of prehospital drug-assisted intubation.
Who cannot join
- All cases where prehospital TI is performed without the use of any drugs.
Trial locations and contacts
2 sites in 1 country.
Sweden2 sites
HEMS VGR
Gothenburg, VästraGötaland
HEMS Dalarna
Mora, Dalarna County
About this study
Official title: PHASTER - 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.
Read the 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.
- Conditions
- Emergency Medicine, Airway Management, Intubation
What is being measured
The primary outcome is the main question the study is designed to answer.
First pass success rate on prehospital 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.
Measured: While handling the patient in need for tracheal intubation
Secondary outcomes (9)
Tracheal intubation performed outside or in-cabin (in helicopter or in ambulance)
The location of the procedure
Measured: While handling the patient case
Number of tracheal intubation attempts
Measured: While handling the patient case
Perceived difficulty of tracheal intubation
Measured on a numeric analogue scale
Measured: While handling the patient case
Time to perform tracheal intubation
Time from first passing teeth with laryngoscope to tube verification with ETCO2 and lung auscultation.
Measured: While handling the patient case
Complications related to the drug assisted intubation
Measured: While handling the patient case
Prehospital mortality
Measured: While handling the patient case
Scene time 1
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).
Measured: While handling the patient case
Scene time 2
Measured from entering patient zone (<3 m) to declaring pilot can switch on helicopter motors.
Measured: While handling the patient case
Ground time
Mesaured from physician leaves helicopter to declaring pilot can switch on helicopter motors.
Measured: While handling the patient case
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2019
- Study start1 Mar 2020
- Primary completion1 Sep 2021
- Study completion1 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Emergency MedicineStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 430 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mikael Gellerfors, Karolinska Institutet
- Investigators
- Mikael Gellerfors, Principal investigator, A PMI, Karolinska University Hospital, Stockholm
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04206566
- Sponsor's protocol ID
- PHASTER-01
- Acronym
- PHASTER
- Status last verified
- Nov 2021
- First submitted
- 18 Dec 2019
- Last updated
- 1 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD
Publications
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;33(1):194. doi: 10.1186/s13049-025-01515-y.
PubMed 41291842Broms 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.
PubMed 37845108
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PHASTER - Pre-Hospital Advanced Airway Management STudying Expedited Routines
- ClinicalTrials.gov ID
- NCT04206566
- Acronym / sponsor ID
- PHASTER / PHASTER-01
- Conditions
- Emergency Medicine, Airway Management, Intubation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 430 participants (actual)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- 1 Sep 2021 (actual)
- Study completion
- 1 Sep 2021 (actual)
- First posted
- 20 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- All drug-assisted intubations performed at the participating HEMSorganizations between 01/01/2020 and 01/09/2021.
Key inclusion criteria (1 listed)
- Patients in need of prehospital drug-assisted intubation.
Key exclusion criteria (1 listed)
- All cases where prehospital TI is performed without the use of any drugs.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
9 secondary outcomes
Tracheal intubation performed outside or in-cabin (in helicopter or in ambulance)
Time frame: While handling the patient case
Number of tracheal intubation attempts
Time frame: While handling the patient case
Perceived difficulty of tracheal intubation
Time frame: While handling the patient case
Time to perform tracheal intubation
Time frame: While handling the patient case
Complications related to the drug assisted intubation
Time frame: While handling the patient case
Prehospital mortality
Time frame: While handling the patient case
Scene time 1
Time frame: While handling the patient case
Scene time 2
Time frame: While handling the patient case
Ground time
Time frame: While handling the patient case
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2021.
- Derived from this study: PubMed 41291842Broms 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;33(1):194. doi: 10.1186/s13049-025-01515-y.
- Derived from this study: PubMed 37845108Broms 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.
- Individual participant dataSharing planned: Yes. All collected IPD
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mikael Gellerfors principal investigator
A PMI, Karolinska University Hospital, Stockholm
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Emergency Medicine and Airway Management, run by Karolinska Institutet at 2 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
First pass success rate on prehospital tracheal intubation (time frame: While handling the patient in need for tracheal intubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04206566, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Dec 2021; AzTrials last refreshed its copy on 7 Nov 2026.