Pre-hospital Advanced Airway Management Studying Expedited Routines (PHASTER)

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.

Study Overview

• Status: Completed
• Conditions: Emergency Medicine; Airway Management; Intubation

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 Type: Observational
• Enrollment (Actual): 430

Contacts and Locations

Study Locations

• Sweden
  • Dalarna
    • Mora, Dalarna, Sweden
      • HEMS Dalarna
  • VästraGötaland
    • Gothenburg, VästraGötaland, Sweden
      • HEMS VGR

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

All drug-assisted intubations performed at the participating HEMSorganizations between 01/01/2020 and 01/09/2021.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	While handling the patient in need for tracheal intubation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Tracheal intubation performed outside or in-cabin (in helicopter or in ambulance)	The location of the procedure	While handling the patient case
Number of tracheal intubation attempts		While handling the patient case
Perceived difficulty of tracheal intubation	Measured on a numeric analogue scale	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.	While handling the patient case
Complications related to the drug assisted intubation		While handling the patient case
Prehospital mortality		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).	While handling the patient case
Scene time 2	Measured from entering patient zone (<3 m) to declaring pilot can switch on helicopter motors.	While handling the patient case
Ground time	Mesaured from physician leaves helicopter to declaring pilot can switch on helicopter motors.	While handling the patient case

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2020
• Primary Completion (Actual): September 1, 2021
• Study Completion (Actual): September 1, 2021

Study Registration Dates

• First Submitted: December 18, 2019
• First Submitted That Met QC Criteria: December 18, 2019
• First Posted (Actual): December 20, 2019

Study Record Updates

• Last Update Posted (Actual): December 1, 2021
• Last Update Submitted That Met QC Criteria: November 30, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Emergencies
• Other Study ID Numbers: PHASTER-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All collected IPD
• IPD Sharing Time Frame: From 2022
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No