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OpenTrials
Completed

NCT Number: NCT02416219

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

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.

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Key information

Conditions

Aspiration Pneumonia Infections Lung Diseases Pneumonia Pneumonia, Aspiration Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

London Health Science Centre

London, Ontario, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

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

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.

Treatment and study plan

Cricoid Pressure

Procedure

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

Ultrasound

Device

Primary outcomes

  1. Distance between measured Cricoid cartilage (by Assessors) and Ultrasound

    Time frame: 10 minutes

  2. The level of difficulty to locate Cricoid cartilage NRS score

    Time frame: 10 minutes

  3. Total time required for assessment

    Time frame: 10 seconds

Sponsors and collaborators

Lead sponsor

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

Other

Registry information

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Apr 14, 2015
Registry last updated
Mar 3, 2016

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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