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

Aspiration Pneumonia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02416219
• Other study ID #: 106074
• Status: Completed
• Phase: N/A
• First received: April 7, 2015
• Last updated: March 2, 2016
• Start date: May 2015
• Est. completion date: March 2016

Study information

• Verified date: March 2016
• Source: Lawson Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 90
• Est. completion date: March 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Aspiration Pneumonia
• Pneumonia, Aspiration

Intervention

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.

Device:
• Ultrasound

Locations

Country	Name	City	State
Canada	London Health Science Centre	London	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distance between measured Cricoid cartilage (by Assessors) and Ultrasound		10 minutes	No
Primary	The level of difficulty to locate Cricoid cartilage NRS score		10 minutes	No
Primary	Total time required for assessment		10 seconds	No