Video Laryngoscopy in Pre-hospital Critical Care

• ClinicalTrials.gov Identifier: NCT02035449
• Recruitment Status: Unknown
• First Posted: January 14, 2014
• Last Update Posted: January 14, 2014
• Sponsor: University of Aarhus
• Information provided by (Responsible Party): University of Aarhus

Tracking Information

• First Submitted Date: January 10, 2014
• First Posted Date: January 14, 2014
• Last Update Posted Date: January 14, 2014
• Study Start Date: December 2013
• Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: January 10, 2014): The incidence of difficult pre-hospital endotracheal intubation [ Time Frame: One year ]
• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Video Laryngoscopy in Pre-hospital Critical Care
• Official Title: Not Provided

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.

• Detailed Description: Not Provided
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Probability 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.

Condition

• Airway Morbidity
• Airway Disease
• Respiratory Insufficiency
• Respiratory Failure

Intervention

Device: McGrath MAC

McGrath MAC is a videolaryngoscope

Study Groups/Cohorts

McGrath MAC

McGrath MAC is a videolaryngscope

Intervention: Device: McGrath MAC

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: January 10, 2014): 150
• Original Estimated Enrollment: Same as current
• Study Completion Date: Not Provided
• Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 15 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Denmark

Administrative Information

• NCT Number: NCT02035449
• Other Study ID Numbers: McGrath MAC 1
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: University of Aarhus
• Study Sponsor: University of Aarhus
• Collaborators: Not Provided

Investigators

• Principal Investigator: Mads P Vandborg, Doctor; Pre-hospital Medical Services, Central Denmark Region

• PRS Account: University of Aarhus
• Verification Date: December 2013