Effect of Incorrectly Applied Cricoid Pressure During Rapid Sequence Induction. Evaluation With High-resolution Manometry.

Cricoid Pressure Clinical Trial

Official title:

Effect of Incorrectly Applied Cricoid Pressure During Rapid Sequence Induction. Evaluation With High-resolution Manometry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02161601
• Other study ID #: RAPESO-01
• Secondary ID: 2012/464
• Status: Completed
• Phase: N/A
• First received: June 10, 2014
• Last updated: June 10, 2014
• Start date: February 2013
• Est. completion date: May 2013

Study information

• Verified date: June 2014
• Source: Örebro University, Sweden
• Contact: n/a
• Is FDA regulated: No
• Health authority: Sweden: Regional Ethical Review Board
• Study type: Interventional

Clinical Trial Summary

During emergency anesthesia (rapid sequence induction) , a firm pressure is applied to the cricoid cartilage of the patient in order to prevent passive regurgitation of gastric content into the pharynx. This maneuver is called cricoid pressure.

Cricoid pressure is often performed incorrectly, due to difficulties to locate the cricoid cartilage in many patients. Despite this, the effectiveness of an incorrectly applied cricoid pressure has not been investigated. In this study we have used high-resolution manometry (HRM) to evaluate pressures in the upper esophagus during correctly applied cricoid pressure (against the cricoid cartilage) compared to incorrectly applied cricoid pressure (against the thyroid cartilage and against the trachea) during a rapid sequence induction.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Elective surgery and Anesthesia with intubation,

• ASA physical status I-II (American Society of Anesthesiologist classification system = system for assessing the fitness of cases before surgery)

• Body Mass Index > 18,5 and < 30

• Informed, signed and dated consent

Exclusion Criteria:

• Suspected difficult airway,

• Pharyngoesophageal dysfunction,

• Body Mass Index < 18,5 or > 30,

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Cricoid Pressure

Intervention

Procedure:
• Cricoid Pressure
Correct Cricoid pressure applied against the cricoid cartilage, Incorrect Cricoid pressure applied against the thyroid cartilage and trachea

Locations

Country	Name	City	State
Sweden	Örebro University Hospital	Örebro

Sponsors (1)

Lead Sponsor	Collaborator
Örebro University, Sweden

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	difference in pressure (mmHg), detected by high resolution solid state manometry, between correctly vs incorrectly applied cricoid pressure		15 sec. during ongoing cricoid pressure application	No