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

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ClinicalTrials.gov Identifier: NCT02161601
Recruitment Status : Completed
First Posted : June 11, 2014
Last Update Posted : June 11, 2014
Sponsor:
Information provided by (Responsible Party):
Richard Pellrud, Örebro University, Sweden

Brief 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.


Condition or disease Intervention/treatment Phase
Cricoid Pressure Procedure: Cricoid Pressure Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Effect of Incorrectly Applied Cricoid Pressure During Rapid Sequence Induction. Evaluation With High-resolution Manometry
Study Start Date : February 2013
Actual Primary Completion Date : May 2013
Actual Study Completion Date : May 2013

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




Primary Outcome Measures :
  1. 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 ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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,

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02161601


Locations
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Sweden
Örebro University Hospital
Örebro, Sweden, S-70356
Sponsors and Collaborators
Örebro University, Sweden

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Responsible Party: Richard Pellrud, MD, Örebro University, Sweden
ClinicalTrials.gov Identifier: NCT02161601     History of Changes
Other Study ID Numbers: RAPESO-01
2012/464 ( Other Identifier: Regional Ethics Committe )
First Posted: June 11, 2014    Key Record Dates
Last Update Posted: June 11, 2014
Last Verified: June 2014

Keywords provided by Richard Pellrud, Örebro University, Sweden:
Cricoid pressure
Rapid Sequence Induction