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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: ClinicalTrials.gov
Last refreshed on: 16 December 2017
Main ID:  NCT02450071
Date of registration: 07/05/2015
Prospective Registration: No
Primary sponsor: Karolinska Institutet
Public title: Pre-Hospital Advanced Airway Management in the Nordic Countries PHAST
Scientific title: Pre-Hospital Advanced Airway Management in the Nordic Countries - A Prospective Multicentre Observational Study
Date of first enrolment: May 1, 2015
Target sample size: 2028
Recruitment status: Completed
URL:  https://clinicaltrials.gov/show/NCT02450071
Study type:  Observational
Study design:   
Phase:  N/A
Countries of recruitment
Sweden
Contacts
Name:     Hans Morten Lossius, MD, PhD
Address: 
Telephone:
Email:
Affiliation:  Norwegian Air Ambulance Foundation
Key inclusion & exclusion criteria

Inclusion Criteria:

All patients requiring prehospital advanced airway management (PHAAM) by the Helicopter
Emergency Medical Services (EMS) and Ground EMS (GEMS) units in the study. PHAAM includes
endotracheal intubation, supraglottic airway and percutaneous/surgical airway. The
indications for performing PHAAM as categorised by Sollid et al. are

- Decreased level of consciousness

- Hypoxemia

- Ineffective ventilation

- Existing airway obstruction

- Impending airway obstruction

- Combative or uncooperative patient

- Relief of pain or distress

- Cardiopulmonary arrest

- Other

Exclusion Criteria:

- Patients receiving advanced airway management during so-called secondary missions (or
inter-hospital transfer)



Age minimum: N/A
Age maximum: N/A
Gender: All
Health Condition(s) or Problem(s) studied
Emergencies
Hypoventilation
Trauma
Cardiac Arrest
Airway Obstruction
Traumatic Brain Injury
Intervention(s)
Primary Outcome(s)
PHETI = 2attempts and no complications [Time Frame: At hospital admission (
Secondary Outcome(s)
Other pre-specified endpoints and analysis as defined by the ERB-submitted protocol [Time Frame: At hospital admission (
Mortality [Time Frame: At 30 days]
PHETI overall success rate [Time Frame: At hospital admission (
Success rate of airway back-up devices [Time Frame: At hospital admission (
PHETI success on 1st attempt and no complications [Time Frame: At hospital admission (
PHETI success rate on 1st, 2nd, 3rd and >3rd attempt [Time Frame: At hospital admission (
Pre-hospital mortality [Time Frame: At hospital admission (
Mortality [Time Frame: At hospital discharge (estimated average 7 days)]
PHAAM Complications [Time Frame: At hospital admission (
PHETI = 2attempts and no complications among patients with TBI [Time Frame: At hospital discharge (estimated average 7 days)]
Secondary ID(s)
PHAST-01
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Norwegian Air Ambulance Foundation
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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