Fibreoptic Intubation With and Without Sellick´s Maneuver

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

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.

Study Overview

• Status: Completed
• Conditions: Respiratory Aspiration of Gastric Contents; Intubation Intraesophageal
• Intervention / Treatment: Procedure: Application 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 Type: Observational
• Enrollment (Anticipated): 50

Contacts and Locations

Study Locations

• Denmark
  • Glostrup, Denmark, 2600
    • Operations- og Anæstesilogisk afd Y, Glostrup Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients admitted for elective surgery at Glostrup University Hospital

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Case-Crossover
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Glostrup University Hospital, Copenhagen
• Investigators: Principal Investigator: Bjørn Arenkiel, MD, Glostrup University Hospital, Copenhagen

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• Brisson P, Brisson M. Variable application and misapplication of cricoid pressure. J Trauma. 2010 Nov;69(5):1182-4. doi: 10.1097/TA.0b013e3181d2793e.
• 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.
• Priebe HJ. Cricoid pressure: an expert's opinion. Minerva Anestesiol. 2009 Dec;75(12):710-4.

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): October 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: May 19, 2011
• First Submitted That Met QC Criteria: May 20, 2011
• First Posted (Estimate): May 23, 2011

Study Record Updates

• Last Update Posted (Estimate): January 31, 2012
• Last Update Submitted That Met QC Criteria: January 29, 2012
• Last Verified: January 1, 2012

More Information

Terms related to this study

• Keywords: Intubation; aspiration; Sellick´s maneuver; [E05.497.578]
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Respiratory Tract Diseases; Respiration Disorders; Gastrointestinal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastroesophageal Reflux; Laryngopharyngeal Reflux; Respiratory Aspiration; Respiratory Aspiration of Gastric Contents
• Other Study ID Numbers: Glostrup Crich Study