Fibreoptic Intubation With and Without Sellick´s Maneuver
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|ClinicalTrials.gov Identifier: NCT01357824|
Recruitment Status : Completed
First Posted : May 23, 2011
Last Update Posted : January 31, 2012
|Condition or disease||Intervention/treatment|
|Intubation Intraesophageal Respiratory Aspiration of Gastric Contents||Procedure: Application of Sellick´s maneuver.|
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 Type :||Observational|
|Estimated Enrollment :||50 participants|
|Official Title:||View af Larynx and Intubation With a Flexible Fibreoptic Scope With and Without Sellick´s Maneuver.|
|Study Start Date :||June 2011|
|Primary Completion Date :||October 2011|
|Study Completion Date :||November 2011|
Patients admitted for elective surgery
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.
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.
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01357824
|Operations- og Anæstesilogisk afd Y, Glostrup Hospital|
|Glostrup, Denmark, 2600|
|Principal Investigator:||Bjørn Arenkiel, MD||Glostrup University Hospital, Copenhagen|