Fibreoptic Intubation With and Without Sellick´s Maneuver

NCT01357824 | Completed

• 1 other identifier: Glostrup Crich Study
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Intubation Intraesophageal; Respiratory Aspiration of Gastric Contents

Keywords

Intubation; Sellick´s maneuver; aspiration; [E05.497.578]

Outcome Measures

Primary Outcomes (1)

• Time of intubation

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

  180 seconds

Secondary Outcomes (3)

• Number of patients that cannot be intubated after 120 sec. with and without Sellick´s maneuver

  180 seconds

• Fall of oxygen saturation after intubation with and without Sellick´s maneuver.

  180 seconds

• Visualization of the vocal cords

  180 seconds

Study Arms (1)

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.

Interventions

Application of Sellick´s maneuver. PROCEDURE

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.

Patients admitted for elective surgery

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients admitted for elective surgery at Glostrup University Hospital

You may qualify if:

• ASA I-II
• Informed consent to participate in the study
• Age 18 or older
• Predicted difficult airways

You may not qualify if:

• Body mass index more then 35
• Patients with an indication for a rapid sequence induction (reflux, Hiatus herniation, Gastric bypass)

Sponsors & Collaborators

• Glostrup University Hospital, Copenhagen: lead

Study Sites (1)

Operations- og Anæstesilogisk afd Y, Glostrup Hospital

Glostrup Municipality, 2600, Denmark

Location

Related Publications (6)

• 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.

  PMID: 12067876 BACKGROUND

• 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.

  PMID: 17573388 BACKGROUND

• 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.

  PMID: 15601271 BACKGROUND

• Brisson P, Brisson M. Variable application and misapplication of cricoid pressure. J Trauma. 2010 Nov;69(5):1182-4. doi: 10.1097/TA.0b013e3181d2793e.

  PMID: 21068621 BACKGROUND

• 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.

  PMID: 17681642 BACKGROUND

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

  PMID: 19940824 BACKGROUND

MeSH Terms

Conditions

Respiratory Aspiration of Gastric Contents

Condition Hierarchy (Ancestors)

Laryngopharyngeal Reflux; Gastroesophageal Reflux; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Respiratory Aspiration; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Bjørn Arenkiel, MD

  Glostrup University Hospital, Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Reservelæge

Study Record Dates

• First Submitted: May 19, 2011
• First Posted: May 23, 2011
• Study Start: June 1, 2011
• Primary Completion: October 1, 2011
• Study Completion: November 1, 2011
• Last Updated: January 31, 2012

Record last verified: 2012-01

Locations

DK (1)