Laryngeal View With Videolaryngoscopy

Hypoxemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01635179
• Other study ID #: Glo-anaest-2012
• Status: Completed
• Phase: N/A
• First received: June 19, 2012
• Last updated: April 24, 2013
• Start date: April 2012
• Est. completion date: September 2012

Study information

• Verified date: April 2013
• Source: Glostrup University Hospital, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: The Danish National Committee on Biomedical Research Ethics
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Hypoxemia
• Respiratory Aspiration

Intervention

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

Locations

Country	Name	City	State
Denmark	Glostrup University Hospital	Glostrup

Sponsors (1)

Lead Sponsor	Collaborator
Glostrup University Hospital, Copenhagen

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes