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

June 10, 2014 updated by: Richard Pellrud, Örebro University, Sweden

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Örebro, Sweden, S-70356
        • Orebro University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Correctly and incorrectly applied cricoid pressure
Procedure: Cricoid Pressure
Correct Cricoid pressure applied against the cricoid cartilage, Incorrect Cricoid pressure applied against the thyroid cartilage and trachea

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
difference in pressure (mmHg), detected by high resolution solid state manometry, between correctly vs incorrectly applied cricoid pressure
Time Frame: 15 sec. during ongoing cricoid pressure application
15 sec. during ongoing cricoid pressure application

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Örebro University, Sweden

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2013

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

June 10, 2014

First Submitted That Met QC Criteria

June 10, 2014

First Posted (Estimate)

June 11, 2014

Study Record Updates

Last Update Posted (Estimate)

June 11, 2014

Last Update Submitted That Met QC Criteria

June 10, 2014

Last Verified

June 1, 2014

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • RAPESO-01
  • 2012/464 (Other Identifier: Regional Ethics Committe)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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