Fibreoptic Intubation With and Without Sellick´s Maneuver

Study Overview
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Brief Summary
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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
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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.

Official Title
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View af Larynx and Intubation With a Flexible Fibreoptic Scope With and Without Sellick´s Maneuver.

Conditions
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Intubation Intraesophageal, Respiratory Aspiration of Gastric Contents

Intervention / Treatment
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* Procedure: Application of Sellick´s maneuver.


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients admitted for elective surgery<br>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. | Procedure: Application of Sellick´s maneuver.<br>* The patient will be intubated with a flexible fiberscope, Olympus model, under the application of Sellick´s maneuver, with the recommended 30 Newtons pressure, and also, as control, be intubated with a sham Sellick´s maneuver, with 0 Newton. The order of the pressures is randomized, and it is blinded to the intubating physician by a cloth which of the maneuvers that is used. The pressure is measured be a pediatric cuff, which is pressed against the throat.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time of intubation | The investigators will find an eventually change in the time of intubation with and without Sellick´s Maneuver | 180 seconds | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Intubation, Sellick´s maneuver, aspiration, [E05.497.578]