Laryngeal View With Videolaryngoscopy

NCT01635179 | Completed DMC

• 1 other identifier: Glo-anaest-2012
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Respiratory Aspiration; Hypoxemia

Keywords

Videolaryngoscopy; Bronchial Aspiration; Hypoxia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• A description of the laryngeal inlet

  120 seconds

Study Arms (1)

Cricoid pressure

EXPERIMENTAL

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

Procedure: Cricoid pressure

Interventions

Cricoid pressure PROCEDURE

The patient is intubated twice, once with a cricoid pressure and once with a sham-pressure, when performing a videolaryngoscopy.

Also known as: Sellicks maneuver., Profylaxis of bronchial aspiration

Cricoid pressure

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• ASA \> 2,
• BMI \> 35,
• RSI

Sponsors & Collaborators

• Glostrup University Hospital, Copenhagen: lead

Study Sites (1)

Glostrup University Hospital

Glostrup Municipality, 2600, Denmark

Location

MeSH Terms

Conditions

Respiratory Aspiration; Hypoxia

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• Bjørn Arenkiel, MD

  GlustrupUH dept of Anaesthesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: June 19, 2012
• First Posted: July 9, 2012
• Study Start: April 1, 2012
• Primary Completion: July 1, 2012
• Study Completion: September 1, 2012
• Last Updated: April 25, 2013

Record last verified: 2013-04

Locations

DK (1)