Clinical Trial: Fibreoptic Intubation With and Without Sellick´s Maneuver

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

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

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 Summary:

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.


Sponsor: Glostrup University Hospital, Copenhagen

Current Primary Outcome: Time of intubation [ Time Frame: 180 seconds ]

The investigators will find an eventually change in the time of intubation with and without Sellick´s Maneuver


Original Primary Outcome: Time of intubation [ Time Frame: 120 seconds ]

The investigators will find an eventually change in the time of intubation with and without Sellick´s Maneuver


Current Secondary Outcome:

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


Original Secondary Outcome:

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


Information By: Glostrup University Hospital, Copenhagen

Dates:
Date Received: May 19, 2011
Date Started: June 2011
Date Completion:
Last Updated: January 29, 2012
Last Verified: January 2012