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Identification of Airway Structures Necessary for Airway Access Via the Skin

Primary Purpose

Upper Airway Obstruction

Status

Completed

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

identification of the airway by from the cranial end

identification of the airway from the distal end

About this trial

This is an interventional diagnostic trial for Upper Airway Obstruction

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

Anaesthesiologist

Exclusion Criteria:

unvillingnes to participate

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Cranial horizontal

caudal longitudinal

Arm Description

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

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

Outcomes

Primary Outcome Measures

time to identify the structures necessary for percutaneous airway acess

Secondary Outcome Measures

Full Information

NCT ID

NCT02613429

First Posted

November 19, 2015

Last Updated

January 3, 2016

Sponsor

Rigshospitalet, Denmark

1. Study Identification

Unique Protocol Identification Number

NCT02613429

Brief Title

Identification of Airway Structures Necessary for Airway Access Via the Skin

Official Title

Identification of Airway Structures Necessary for Airway Access Via the Skin to be Used in Case of Failure to Maintain Oxygenation With Non-invasive Methods

Study Type

Interventional

2. Study Status

Record Verification Date

January 2016

Overall Recruitment Status

Completed

Study Start Date

November 2015 (undefined)

Primary Completion Date

December 2015 (Actual)

Study Completion Date

December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Rigshospitalet, Denmark

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Upper Airway Obstruction

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

42 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cranial horizontal

Arm Type

Active Comparator

Arm Description

Arm Title

caudal longitudinal

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Behavioral

Intervention Name(s)

identification of the airway by from the cranial end

Intervention Description

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

Intervention Type

Behavioral

Intervention Name(s)

identification of the airway from the distal end

Intervention Description

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

Primary Outcome Measure Information:

Title

time to identify the structures necessary for percutaneous airway acess

Time Frame

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Anaesthesiologist Exclusion Criteria: unvillingnes to participate

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Michael S Kristensen, M.D.

Organizational Affiliation

Rigshospitalet, Denmark

Official's Role

Study Chair

Facility Information:

Facility Name

Rigshospitalet, department of anaesthesia

City

Copenhagen

ZIP/Postal Code

2000

Country

Denmark

Facility Name

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

City

Copenhagen

ZIP/Postal Code

2100

Country

Denmark

12. IPD Sharing Statement

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Identification of Airway Structures Necessary for Airway Access Via the Skin

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