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

NCT ID: NCT02161601

Last Updated: 2014-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Study Completion Date

2013-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Cricoid Pressure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Correctly and incorrectly applied cricoid pressure

Group Type EXPERIMENTAL

Cricoid Pressure

Intervention Type PROCEDURE

Correct Cricoid pressure applied against the cricoid cartilage, Incorrect Cricoid pressure applied against the thyroid cartilage and trachea

Interventions

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Cricoid Pressure

Correct Cricoid pressure applied against the cricoid cartilage, Incorrect Cricoid pressure applied against the thyroid cartilage and trachea

Intervention Type PROCEDURE

Eligibility Criteria

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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,
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Örebro University, Sweden

OTHER

Sponsor Role lead

Responsible Party

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Richard Pellrud

MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Örebro University Hospital

Örebro, , Sweden

Site Status

Countries

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Sweden

Other Identifiers

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2012/464

Identifier Type: OTHER

Identifier Source: secondary_id

RAPESO-01

Identifier Type: -

Identifier Source: org_study_id

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