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Laryngeal View With Videolaryngoscopy

Primary Purpose

Respiratory Aspiration, Hypoxemia

Status
Completed
Phase
Not Applicable
Locations
Denmark
Study Type
Interventional
Intervention
Cricoid pressure
Sponsored by
Glostrup University Hospital, Copenhagen
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Respiratory Aspiration focused on measuring Videolaryngoscopy, Bronchial Aspiration, Hypoxia

Eligibility Criteria

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

Inclusion Criteria:

  • ASA 1-2, BMI < 35,
  • no indication for rapid sequence induction,
  • age > 18,
  • able to give consent.

Exclusion Criteria:

  • ASA > 2,
  • BMI > 35,
  • RSI

Sites / Locations

  • Glostrup University Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cricoid pressure

Arm Description

A cricoid pressure of 30 N is done to occlude esophagus under a rapid sequence induction.

Outcomes

Primary Outcome Measures

Completed intubation within 120 seconds
The primary outcome measure is the rate of completed and failed intubations. A intubations is failed when the oxygen saturation is less then 95% or the intubation time is longer then 120 seconds.

Secondary Outcome Measures

A description of the laryngeal inlet
The secondary outcome measure is a description of the laryngeal inlet according the the Cormack-Lehan system, and how Sellicks Maneuver alters that view.

Full Information

First Posted
June 19, 2012
Last Updated
April 24, 2013
Sponsor
Glostrup University Hospital, Copenhagen
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1. Study Identification

Unique Protocol Identification Number
NCT01635179
Brief Title
Laryngeal View With Videolaryngoscopy
Official Title
Laryngeal View With Intubation by Videolaryngoscopy With and Without Sellicks Maneuver.
Study Type
Interventional

2. Study Status

Record Verification Date
April 2013
Overall Recruitment Status
Completed
Study Start Date
April 2012 (undefined)
Primary Completion Date
July 2012 (Actual)
Study Completion Date
September 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Glostrup University Hospital, Copenhagen

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
To prevent bronchial aspiration during induction of anaesthesia it has been a common procedure to perform a cricoid pressure, called Sellicks Maneuver, to occlude esophagus, and thereby prevent aspiration. During the last ten years the efficiency of this maneuver has been discussed, since it probably prolong the intubation time and do not significantly reduces the risk of aspiration. The hypothesis is that Sellicks Maneuver prolong the time of intubation and reduces the view of the laryngeal inlet, during intubation with a videolaryngoscopy. The hypothesis is tested by a double-blinded randomized study where patients is intubated twice, with and without Sellicks Maneuver, in a randomized order. The specific cricoid pressure is blinded to the personal performing the intubation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Aspiration, Hypoxemia
Keywords
Videolaryngoscopy, Bronchial Aspiration, Hypoxia

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
N/A
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cricoid pressure
Arm Type
Experimental
Arm Description
A cricoid pressure of 30 N is done to occlude esophagus under a rapid sequence induction.
Intervention Type
Procedure
Intervention Name(s)
Cricoid pressure
Other Intervention Name(s)
Sellicks maneuver., Profylaxis of bronchial aspiration
Intervention Description
The patient is intubated twice, once with a cricoid pressure and once with a sham-pressure, when performing a videolaryngoscopy.
Primary Outcome Measure Information:
Title
Completed intubation within 120 seconds
Description
The primary outcome measure is the rate of completed and failed intubations. A intubations is failed when the oxygen saturation is less then 95% or the intubation time is longer then 120 seconds.
Time Frame
120 seconds
Secondary Outcome Measure Information:
Title
A description of the laryngeal inlet
Description
The secondary outcome measure is a description of the laryngeal inlet according the the Cormack-Lehan system, and how Sellicks Maneuver alters that view.
Time Frame
120 seconds

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: ASA 1-2, BMI < 35, no indication for rapid sequence induction, age > 18, able to give consent. Exclusion Criteria: ASA > 2, BMI > 35, RSI
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bjørn Arenkiel, MD
Organizational Affiliation
GlustrupUH dept of Anaesthesia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Glostrup University Hospital
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark

12. IPD Sharing Statement

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Laryngeal View With Videolaryngoscopy

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