Clinical trial NCT02416219: Efficacy of Surface Landmark Palpation for Identification of the Cricoid Cartilage in Obstetric Patients
Official title: Efficacy of Surface Landmark Palpation for Identification of the Cricoid Cartilage in Obstetric Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aspiration Pneumonia
Keywords: Cricoid cartilage, cricoid pressure, obstetric
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
First posted: 2015-04-14
Enrollment: 90
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Term Obstetric patients coming for elective cesarean delivery

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Distance between measured Cricoid cartilage (by Assessors) and Ultrasound
timeFrame: 10 minutes
measure: The level of difficulty to locate Cricoid cartilage NRS score
timeFrame: 10 minutes
measure: Total time required for assessment
timeFrame: 10 seconds
Secondary outcomes:
Other outcomes:
Locations:
city: London
country: Canada
facility: London Health Science Centre
state: Ontario
Study officials:
affiliation: Western University, Schulish school of Medicine, Department of Anesthesia
name: Indu Singh, MD, FRCPC
role: PRINCIPAL_INVESTIGATOR
References:
citation: Zeidan AM, Salem MR, Mazoit JX, Abdullah MA, Ghattas T, Crystal GJ. The effectiveness of cricoid pressure for occluding the esophageal entrance in anesthetized and paralyzed patients: an experimental and observational glidescope study. Anesth Analg. 2014 Mar;118(3):580-6. doi: 10.1213/ANE.0000000000000068.
citation: Benhamou D, Bouaziz H, Chassard D, Ducloy JC, Fuzier V, Laffon M, Mercier F, Raucoules M, Samii K. Anaesthetic practices for scheduled caesarean delivery: a 2005 French national survey. Eur J Anaesthesiol. 2009 Aug;26(8):694-700. doi: 10.1097/EJA.0b013e328329b071.
citation: Fenton PM, Reynolds F. Life-saving or ineffective? An observational study of the use of cricoid pressure and maternal outcome in an African setting. Int J Obstet Anesth. 2009 Apr;18(2):106-10. doi: 10.1016/j.ijoa.2008.07.006. Epub 2009 Jan 13.
citation: Aslani A, Ng SC, Hurley M, McCarthy KF, McNicholas M, McCaul CL. Accuracy of identification of the cricothyroid membrane in female subjects using palpation: an observational study. Anesth Analg. 2012 May;114(5):987-92. doi: 10.1213/ANE.0b013e31824970ba. Epub 2012 Feb 24.
citation: Hung O, Scott J, Mullen T, Murphy M. Waiting to exhale! Anesth Analg. 2012 May;114(5):927-8. doi: 10.1213/ANE.0b013e31823a84ef. No abstract available.
citation: Singh M, Chin KJ, Chan VW, Wong DT, Prasad GA, Yu E. Use of sonography for airway assessment: an observational study. J Ultrasound Med. 2010 Jan;29(1):79-85. doi: 10.7863/jum.2010.29.1.79.