Laryngeal View With Videolaryngoscopy

Laryngeal View With Intubation by Videolaryngoscopy With and Without Sellicks Maneuver.

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Aspiration; Hypoxemia
• Intervention / Treatment: Procedure: Cricoid pressure

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Denmark
  • Glostrup, Denmark, 2600
    • Glostrup University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: Double

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Cricoid pressure; A cricoid pressure of 30 N is done to occlude esophagus under a rapid sequence induction.	Procedure: Cricoid pressure; The patient is intubated twice, once with a cricoid pressure and once with a sham-pressure, when performing a videolaryngoscopy.; Other Names: Sellicks maneuver.; Profylaxis of bronchial aspiration

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	120 seconds

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	120 seconds

Collaborators and Investigators

• Sponsor: Glostrup University Hospital, Copenhagen
• Investigators: Principal Investigator: Bjørn Arenkiel, MD, GlustrupUH dept of Anaesthesia

Study record dates

Study Major Dates

• Study Start: April 1, 2012
• Primary Completion (Actual): July 1, 2012
• Study Completion (Actual): September 1, 2012

Study Registration Dates

• First Submitted: June 19, 2012
• First Submitted That Met QC Criteria: July 6, 2012
• First Posted (Estimate): July 9, 2012

Study Record Updates

• Last Update Posted (Estimate): April 25, 2013
• Last Update Submitted That Met QC Criteria: April 24, 2013
• Last Verified: April 1, 2013

More Information

Terms related to this study

• Keywords: Hypoxia; Videolaryngoscopy; Bronchial Aspiration
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Signs and Symptoms, Respiratory; Respiratory Aspiration; Hypoxia
• Other Study ID Numbers: Glo-anaest-2012

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No