Efficacy of Surface Landmark Palpation for Identification of the Cricoid Cartilage in Obstetric Patients

March 2, 2016 updated by: Fatemah Qasem, Lawson Health Research Institute
Rapid Sequence Induction (RSI), with cricoid pressure is advocated for all obstetric patients undergoing general anesthesia. Applying cricoid pressure correctly is crucial to prevent aspiration. Using Ultrasound guidance we will be assessing the ability of different disciplines of caregivers to correctly localize the cricoid cartilage in obstetric patients by anatomical landmark palpation.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Obstetric patients coming for elective cesarean delivery will be recruited for the study. Informed consent will be obtained from the patient. The participant (anesthesiologist, resident, nurse, or RT) will mark the center of the cricoid cartilage with the patient in the sniffing position, using fluorescent "invisible" ink. Another anesthesiologist who is expert in using ultrasound will find the proximal and distal margins of the cricoid cartilage an will draw a line at the middle of the 2 margins. Evaluation of the participant's assessment will be considered accurate if it falls within 5 mm from the ultrasound's measured line .The assessor will also be asked to score the ease of cricoid cartilage palpation between 1 to 10 using a visual analog scoring (VAS) scale. Total time taken for palpation will also be measured.

Study Type

Observational

Enrollment (Actual)

90

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

  • Canada
    • Ontario
      • London, Ontario, Canada
        • London Health Science Centre

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Term Obstetric patients coming for elective cesarean delivery

Description

Inclusion Criteria:

  • Patient 18 years and older
  • ASA 1-2•Having singleton pregnancy.
  • Gestational age >37.
  • Elective cesarean section

Exclusion Criteria:

  • Patient refusal.
  • Renal failure.
  • Severe preeclampsia.
  • Non- scheduled caesarean delivery (urgent).
  • Twin pregnancy.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cricoid Cartilage localization
The caregiver will be asked to palpate the cricoid cartilage and draw aline where he will apply cricoid pressure during rapid sequence induction
Device: Ultrasound
Procedure: Cricoid pressure
participants will ask to mark the place where they will apply cricoid pressure if the patients was undergoing rapid sequence induction. US will be used to confirm how accurate they are in their estimation.
Other Names:
  • Sellick's Maneuver

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Distance between measured Cricoid cartilage (by Assessors) and Ultrasound
Time Frame: 10 minutes
10 minutes
The level of difficulty to locate Cricoid cartilage NRS score
Time Frame: 10 minutes
10 minutes
Total time required for assessment
Time Frame: 10 seconds
10 seconds

Collaborators and Investigators

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

Sponsor

Lawson Health Research Institute

Investigators

  • Principal Investigator: Indu Singh, MD, FRCPC, Western University, Schulish school of Medicine, Department of Anesthesia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

May 1, 2015

Primary Completion (Actual)

February 1, 2016

Study Completion (Actual)

March 1, 2016

Study Registration Dates

First Submitted

April 7, 2015

First Submitted That Met QC Criteria

April 13, 2015

First Posted (Estimate)

April 14, 2015

Study Record Updates

Last Update Posted (Estimate)

March 3, 2016

Last Update Submitted That Met QC Criteria

March 2, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 106074

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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