Fibreoptic Intubation With and Without Sellick´s Maneuver

Respiratory Aspiration of Gastric Contents Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01357824
• Other study ID #: Glostrup Crich Study
• Status: Completed
• Phase: N/A
• First received: May 19, 2011
• Last updated: January 29, 2012
• Start date: June 2011
• Est. completion date: November 2011

Study information

• Verified date: January 2012
• Source: Glostrup University Hospital, Copenhagen
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Datatilsynet
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Crossover, Time Perspective: Prospective

Related Conditions & MeSH terms

• Intubation Intraesophageal
• Respiratory Aspiration
• Respiratory Aspiration of Gastric Contents

Intervention

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.

Locations

Country	Name	City	State
Denmark	Operations- og Anæstesilogisk afd Y, Glostrup Hospital	Glostrup

Sponsors (1)

Lead Sponsor	Collaborator
Glostrup University Hospital, Copenhagen

Country where clinical trial is conducted

Denmark, 

References & Publications (6)

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. Epub 2007 Jun 15. — View 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. — View 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. Epub 2007 Aug 3. Review. — View Citation

Haslam N, Parker L, Duggan JE. Effect of cricoid pressure on the view at laryngoscopy. Anaesthesia. 2005 Jan;60(1):41-7. — View Citation

Priebe HJ. Cricoid pressure: an expert's opinion. Minerva Anestesiol. 2009 Dec;75(12):710-4. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time of intubation	The investigators will find an eventually change in the time of intubation with and without Sellick´s Maneuver	180 seconds	Yes
Secondary	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	Yes
Secondary	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	Yes
Secondary	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	Yes