Pre-hospital Advanced Airway Management Studying Expedited Routines

Intubation Clinical Trial

— PHASTER  

Official title:

PHASTER - Pre-Hospital Advanced Airway Management STudying Expedited Routines

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04206566
• Other study ID #: PHASTER-01
• Status: Completed
• Start date: March 1, 2020
• Est. completion date: September 1, 2021

Study information

• Verified date: November 2021
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 430
• Est. completion date: September 1, 2021
• Est. primary completion date: September 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Airway Management
• Emergencies
• Emergency Medicine
• Intubation

Locations

Country	Name	City	State
Sweden	HEMS VGR	Gothenburg	VästraGötaland
Sweden	HEMS Dalarna	Mora	Dalarna

Sponsors (1)

Lead Sponsor	Collaborator
Karolinska Institutet

Country where clinical trial is conducted

Sweden, 

Outcome

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