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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT02035449
Other study ID # McGrath MAC 1
Secondary ID
Status Recruiting
Phase N/A
First received January 10, 2014
Last updated January 10, 2014
Start date December 2013

Study information

Verified date December 2013
Source University of Aarhus
Contact Mads P Vandborg, Doctor
Phone +45 78445224
Email madvan@rm.dk
Is FDA regulated No
Health authority Denmark: Danish Dataprotection Agency
Study type Observational

Clinical Trial Summary

Difficult conditions and critically ill and injured patients may complicate endotracheal intubation in the pre-hospital setting. The incidence of complications increase when two or more endotracheal intubation attempts are needed.

The aim of this study is to estimate the incidence of difficult pre-hospital endotracheal intubation after the introduction of the McGrath MAC Video laryngoscope as the primary airway device for pre-hospital endotracheal intubation.

Hypothesis:

• In our pre-hospital critical care teams, staffed with experienced anaesthesiologists, the rate of difficult PHETI (defined as more than one intubation attempt needed to secure a patent airway) is lower than 10 %, when using the McGrath MAC VL as primary choice in pre-hospital intubations.


Recruitment information / eligibility

Status Recruiting
Enrollment 150
Est. completion date
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 15 Years and older
Eligibility Inclusion Criteria:

- Patients where the anaesthesiologists on the participating pre-hospital critical care teams attempt prehospital endotracheal intubation.

Exclusion Criteria:

- Patients< 15 years of age

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Intervention

Device:
McGrath MAC
McGrath MAC is a videolaryngoscope

Locations

Country Name City State
Denmark Pre-hospital Medical Services, Central Denmark Region Aarhus

Sponsors (1)

Lead Sponsor Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary The incidence of difficult pre-hospital endotracheal intubation One year No
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