Fibreoptic Intubation With and Without Sellick´s Maneuver

Completed

• Conditions: Intubation Intraesophageal; Respiratory Aspiration of Gastric Contents
• Interventions: Procedure: Application of Sellick´s maneuver.

• Registration Number: NCT01357824
• Lead Sponsor: Glostrup University Hospital, Copenhagen

Brief Summary

The goal of this study is to evaluate the effect of Sellick´s Maneuver, a firm pressure on the throat, just below the Adams apple, to occlude the esophagus, in order to prevent aspiration of gastric contents, on intubation with a flexible fiberscope. The result of this study will be participate in the discussion of the importance of Sellick´s Maneuver.

Detailed Description

The patients included in this study has volunteered after sufficient information, and must be ASA-class I-II, 18 years or more, and must not have indications for a rapid sequence induction.

The patient will be intubated twice, with and without Sellick´s maneuver. It is blinded to the intubating physician, in which order this pressure is applied.

The outcomes measures will be time of intubation, oxygen saturation before and after intubation and a Cormack Scale graduation of the visibility of the vocal cords. The intubation will be failed, if it cannot be performed under 120 seconds, or if the patients desaturate to 95% or less.

Study Timeline

• Study First Submitted: 2011-05-19
• Study First Submitted QC: 2011-05-20
• Study First Posted: 2011-05-23
• Study Start: 2011-06
• Primary Completion: 2011-10
• Study Completion: 2011-11
• Status Verified: 2012-01
• Last Update Submitted: 2012-01-29
• Last Update Posted: 2012-01-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• ASA I-II
• Informed consent to participate in the study
• Age 18 or older
• Predicted difficult airways

Exclusion Criteria

• Body mass index more then 35
• Patients with an indication for a rapid sequence induction (reflux, Hiatus herniation, Gastric bypass)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients admitted for elective surgery	Application of Sellick´s maneuver.	The patient admitted for elective surgery can be included, and will both the case and control, as we intubate the same patient twice, with and without Sellick´s maneuver.

Primary Outcome Measures

Name	Time	Method
Time of intubation	180 seconds	The investigators will find an eventually change in the time of intubation with and without Sellick´s Maneuver

Secondary Outcome Measures

Name	Time	Method
Visualization of the vocal cords	180 seconds	The investigators will observe the visualization of the vocal cords, and provide the result on the Cormack Score.
Fall of oxygen saturation after intubation with and without Sellick´s maneuver.	180 seconds	The investigators measure the oxygen saturation on a finger device at the beginning and the and of the intubations.
Number of patients that cannot be intubated after 120 sec. with and without Sellick´s maneuver	180 seconds	Patients that is not intubated after 120 seconds in each trial, will count as "not intubated after 120 seconds".

Trial Locations

Locations (1)

Operations- og Anæstesilogisk afd Y, Glostrup Hospital; 🇩🇰 Glostrup, Denmark