NCT02613429

Brief Summary

Literature shows that anaesthetists have a low success-rate when trying to access the airway percutaneously in case of failed ventilation and intubation. The study will investigate anaesthetists ability to locate the trachea and the thyroid cartilage and the cricoid cartilage in patients, using different methods including application of ultrasonography.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Nov 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

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

November 1, 2015

Completed
18 days until next milestone

First Submitted

Initial submission to the registry

November 19, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

November 24, 2015

Completed
7 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2015

Completed
Last Updated

January 5, 2016

Status Verified

January 1, 2016

Enrollment Period

1 month

First QC Date

November 19, 2015

Last Update Submit

January 3, 2016

Conditions

Outcome Measures

Primary Outcomes (1)

  • time to identify the structures necessary for percutaneous airway acess

    two minutes after initiation of the attempt to identify the airway structures

Study Arms (2)

Cranial horizontal

ACTIVE COMPARATOR

identification of the airway by from the cranial end. Marking of the airway, including the cricothyroid membrane, on the skin, by starting the examination from the cranial end at the level of the thyroid catilage , horizontally and thereafter moving caudally

Behavioral: identification of the airway by from the cranial end

caudal longitudinal

ACTIVE COMPARATOR

identification of the airway from the distal end. Marking of the airway, including the cricothyroid membrane, on the skin, by starting the examination caudally, and then moving cranially

Behavioral: identification of the airway from the distal end

Interventions

The airway is identified with inspection and imaging technique (ultrasound) by placing the ultrasound transducer over the thyroid cartilage and from there moving distally

Cranial horizontal

The airway is identified with inspection and imaging technique (ultrasound) by placing the ultrasound transducer over the distal trachea and moving cranially

caudal longitudinal

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Anaesthesiologist

You may not qualify if:

  • unvillingnes to participate

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Rigshospitalet, department of anaesthesia

Copenhagen, 2000, Denmark

Location

Rigshospitalet, section for anaesthesia for ENT and Maxillofacial surgery, section 3071

Copenhagen, 2100, Denmark

Location

MeSH Terms

Conditions

Airway Obstruction

Condition Hierarchy (Ancestors)

Respiratory InsufficiencyRespiration DisordersRespiratory Tract Diseases

Study Officials

  • Michael S Kristensen, M.D.

    Rigshospitalet, Denmark

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of clinical anaesthesia and research, ENT and max fax

Study Record Dates

First Submitted

November 19, 2015

First Posted

November 24, 2015

Study Start

November 1, 2015

Primary Completion

December 1, 2015

Study Completion

December 1, 2015

Last Updated

January 5, 2016

Record last verified: 2016-01

Locations