NCT02161601

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2013

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2013

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 10, 2014

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 11, 2014

Completed
Last Updated

June 11, 2014

Status Verified

June 1, 2014

Enrollment Period

3 months

First QC Date

June 10, 2014

Last Update Submit

June 10, 2014

Conditions

Cricoid Pressure

Keywords

Cricoid pressureRapid Sequence Induction

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

Correctly and incorrectly applied cricoid pressure

EXPERIMENTAL
Procedure: Cricoid Pressure

Interventions

Cricoid PressurePROCEDURE

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

Correctly and incorrectly applied cricoid pressure

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Suspected difficult airway,
  • Pharyngoesophageal dysfunction,
  • Body Mass Index \< 18,5 or \> 30,

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Örebro University Hospital

Örebro, S-70356, Sweden

Location

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

June 10, 2014

First Posted

June 11, 2014

Study Start

February 1, 2013

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

June 11, 2014

Record last verified: 2014-06

Locations

SE(1)