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Completed

NCT Number: NCT02161601

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.

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Key information

Conditions

Cricoid Pressure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Örebro University Hospital

Örebro, S-70356, Sweden

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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,

Treatment and study plan

Cricoid Pressure

Procedure

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

Primary outcomes

  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

Sponsors and collaborators

Lead sponsor

Örebro University, Sweden

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2013
Study completion
2013
First posted
Jun 11, 2014
Registry last updated
Jun 11, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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