Clinical trial NCT01357824: Fibreoptic Intubation With and Without Sellick´s Maneuver
Official title: View af Larynx and Intubation With a Flexible Fibreoptic Scope With and Without Sellick´s Maneuver.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intubation Intraesophageal
Respiratory Aspiration of Gastric Contents
Keywords: Intubation
Sellick´s maneuver
aspiration
[E05.497.578]
Lead sponsor: Glostrup University Hospital, Copenhagen
Sponsor class: OTHER
First posted: 2011-05-23
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CROSSOVER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients admitted for elective surgery at Glostrup University Hospital

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Time of intubation
timeFrame: 180 seconds
Secondary outcomes:
measure: Number of patients that cannot be intubated after 120 sec. with and without Sellick´s maneuver
timeFrame: 180 seconds
measure: Fall of oxygen saturation after intubation with and without Sellick´s maneuver.
timeFrame: 180 seconds
measure: Visualization of the vocal cords
timeFrame: 180 seconds
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Operations- og Anæstesilogisk afd Y, Glostrup Hospital
Study officials:
affiliation: Glostrup University Hospital, Copenhagen
name: Bjørn Arenkiel, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Smith CE, Boyer D. Cricoid pressure decreases ease of tracheal intubation using fibreoptic laryngoscopy (WuScope System. Can J Anaesth. 2002 Jun-Jul;49(6):614-9. doi: 10.1007/BF03017391.
citation: Asai T, Goy RW, Liu EH. Cricoid pressure prevents placement of the laryngeal tube and laryngeal tube-suction II. Br J Anaesth. 2007 Aug;99(2):282-5. doi: 10.1093/bja/aem159. Epub 2007 Jun 15.
citation: Haslam N, Parker L, Duggan JE. Effect of cricoid pressure on the view at laryngoscopy. Anaesthesia. 2005 Jan;60(1):41-7. doi: 10.1111/j.1365-2044.2004.04010.x.
citation: Brisson P, Brisson M. Variable application and misapplication of cricoid pressure. J Trauma. 2010 Nov;69(5):1182-4. doi: 10.1097/TA.0b013e3181d2793e.
citation: Ellis DY, Harris T, Zideman D. Cricoid pressure in emergency department rapid sequence tracheal intubations: a risk-benefit analysis. Ann Emerg Med. 2007 Dec;50(6):653-65. doi: 10.1016/j.annemergmed.2007.05.006. Epub 2007 Aug 3.
citation: Priebe HJ. Cricoid pressure: an expert's opinion. Minerva Anestesiol. 2009 Dec;75(12):710-4.