NCT02035449

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
150

participants targeted

Target at P50-P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

January 10, 2014

Completed
4 days until next milestone

First Posted

Study publicly available on registry

January 14, 2014

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Last Updated

January 14, 2014

Status Verified

December 1, 2013

Enrollment Period

1 year

First QC Date

January 10, 2014

Last Update Submit

January 10, 2014

Conditions

Airway MorbidityAirway DiseaseRespiratory InsufficiencyRespiratory Failure

Keywords

Video laryngoscopePre-hospitalEndotracheal intubationDifficult endotracheal intubationPre hospital Critical careMcGrath MACAirway device

Outcome Measures

Primary Outcomes (1)

  • The incidence of difficult pre-hospital endotracheal intubation

    One year

Study Arms (1)

McGrath MAC

McGrath MAC is a videolaryngscope

Device: McGrath MAC

Interventions

McGrath MACDEVICE

McGrath MAC is a videolaryngoscope

McGrath MAC

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients in the Central Region of Denmark where the anaesthesiologists on the participating pre-hospital critical care teams attempt prehospital endotracheal intubation.

You may qualify if:

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

You may not qualify if:

  • Patients\< 15 years of age

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pre-hospital Medical Services, Central Denmark Region

Aarhus, 8200, Denmark

RECRUITING

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract Diseases

Study Officials

  • Mads P Vandborg, Doctor

    Pre-hospital Medical Services, Central Denmark Region

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mads P Vandborg, Doctor

CONTACT

+45 78445224madvan@rm.dk

Leif Rognaas, Doctor

CONTACT

leifrogn@rm.dk

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2014

First Posted

January 14, 2014

Study Start

December 1, 2013

Primary Completion

December 1, 2014

Last Updated

January 14, 2014

Record last verified: 2013-12

Locations

DK(1)