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

Sponsor
Lawson Health Research Institute (Other)
Overall Status
Completed
CT.gov ID
NCT02416219
Collaborator
(none)
90
1
10
9

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Cricoid pressure
  • Device: Ultrasound

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 Design

Study Type:
Observational
Actual Enrollment :
90 participants
Observational Model:
Case-Only
Time Perspective:
Prospective
Official Title:
Efficacy of Surface Landmark Palpation for Identification of the Cricoid Cartilage in Obstetric Patients
Study Start Date :
May 1, 2015
Actual Primary Completion Date :
Feb 1, 2016
Actual Study Completion Date :
Mar 1, 2016

Arms and Interventions

Arm 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

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
  • Device: Ultrasound

    Outcome Measures

    Primary Outcome Measures

    1. Distance between measured Cricoid cartilage (by Assessors) and Ultrasound [10 minutes]

    2. The level of difficulty to locate Cricoid cartilage NRS score [10 minutes]

    3. Total time required for assessment [10 seconds]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 London Health Science Centre London Ontario Canada

    Sponsors and Collaborators

    • Lawson Health Research Institute

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Fatemah Qasem, Clinical fellow, Lawson Health Research Institute
    ClinicalTrials.gov Identifier:
    NCT02416219
    Other Study ID Numbers:
    • 106074
    First Posted:
    Apr 14, 2015
    Last Update Posted:
    Mar 3, 2016
    Last Verified:
    Mar 1, 2016
    Keywords provided by Fatemah Qasem, Clinical fellow, Lawson Health Research Institute
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Mar 3, 2016