Ultrasound Guided Cricoid and Paralaryngeal Pressure

Ultrasonography, Interventional Clinical Trial

Official title:

Impact of Ultrasound Guidance on the Performance of Accurate Cricoid and Paralaryngeal Pressure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04317976
• Other study ID #: 2018118-6867
• Secondary ID: 45835
• Status: Completed
• Phase: N/A
• Start date: February 1, 2019
• Est. completion date: July 31, 2019

Study information

• Verified date: March 2020
• Source: University of Malaya
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The primary objective is to study impact of upper airway ultrasonography in guiding anaesthetic assistant into providing accurate cricoid pressure, or both cricoid and paralaryngeal pressure in those with oesophagus deviation, achieving sonographic proven oesophageal occlusion compared to those without ultrasound guidance.

Description:

All patients consented for the study were having their airway examined via US. Cross sectional sonography of the airway was performed to determine the anatomic relationship of the oesophagus relative to the trachea:

1. before induction of anaesthesia

2. after GA before external airway pressure manoeuvre

3. after GA with external airway pressure manoeuvre.

US guided CP was applied on subjects with central oesophagus; CP and PLP were applied on subject with eccentric oesophagus anatomy.

PLP was performed by lateral compression on the eccentric oesophagus by fingertips under US guidance. To standardised the application of CP and PLP, only 2 well trained investigators were allowed to performed the CP and PLP, US scan on airway and patient recruitment. The conduct of trial involved 2 investigators where first investigator provide US scan, and second investigator provide compression of CP or PLP using fingertips guided by the instruction of first investigator.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: July 31, 2019
• Est. primary completion date: May 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

Elective list Under general anaesthesia Not intubated prior to OT

Exclusion Criteria:

Below 18 years old Pregnant Neck deformities Previous maxillofacial surgery

Related Conditions & MeSH terms

• Ultrasonography, Interventional

Intervention

Other:
• paralaryngeal pressure
cricoid pressure with paralaryngeal pressure by fingertips applied under ultrasound guidance
• cricoid pressure
cricoid pressure by fingertips applied under ultrasound guidance

Locations

Country	Name	City	State
Malaysia	University Malaya Medical Centre	Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaya

Country where clinical trial is conducted

Malaysia, 

References & Publications (10)

Andruszkiewicz P, Wojtczak J, Wroblewski L, Kaczor M, Sobczyk D, Kowalik I. Ultrasound evaluation of the impact of cricoid pressure versus novel 'paralaryngeal pressure' on anteroposterior oesophageal diameter. Anaesthesia. 2016 Sep;71(9):1024-9. doi: 10.1111/anae.13518. — View Citation

Bhatia N, Bhagat H, Sen I. Cricoid pressure: Where do we stand? J Anaesthesiol Clin Pharmacol. 2014 Jan;30(1):3-6. doi: 10.4103/0970-9185.125683. Review. — View Citation

Byas-Smith M, Prinsell JR Jr. Ultrasound-guided esophageal occlusion during rapid sequence induction. Can J Anaesth. 2013 Mar;60(3):327-8. doi: 10.1007/s12630-012-9847-9. Epub 2012 Dec 20. — View Citation

Kei J, Utschig EE, van Tonder RJ. Using Ultrasonography to Assess the Effectiveness of Cricoid Pressure on Esophageal Compression. J Emerg Med. 2017 Aug;53(2):236-240. doi: 10.1016/j.jemermed.2017.04.025. Epub 2017 Jun 8. — View Citation

Lee D, Czech AJ, Elriedy M, Nair A, El-Boghdadly K, Ahmad I. A multicentre prospective cohort study of the accuracy of conventional landmark technique for cricoid localisation using ultrasound scanning. Anaesthesia. 2018 Oct;73(10):1229-1234. doi: 10.1111/anae.14399. Epub 2018 Jul 25. — View Citation

Rice MJ, Mancuso AA, Gibbs C, Morey TE, Gravenstein N, Deitte LA. Cricoid pressure results in compression of the postcricoid hypopharynx: the esophageal position is irrelevant. Anesth Analg. 2009 Nov;109(5):1546-52. doi: 10.1213/ane.0b013e3181b05404. — View Citation

SELLICK BA. Cricoid pressure to control regurgitation of stomach contents during induction of anaesthesia. Lancet. 1961 Aug 19;2(7199):404-6. — View Citation

Smith KJ, Dobranowski J, Yip G, Dauphin A, Choi PT. Cricoid pressure displaces the esophagus: an observational study using magnetic resonance imaging. Anesthesiology. 2003 Jul;99(1):60-4. — View Citation

Smith KJ, Ladak S, Choi PT, Dobranowski J. The cricoid cartilage and the esophagus are not aligned in close to half of adult patients. Can J Anaesth. 2002 May;49(5):503-7. — View Citation

Votruba J, Zemanová P, Lambert L, Vesela MM. The Role of Airway and Endobronchial Ultrasound in Perioperative Medicine. Biomed Res Int. 2015;2015:754626. doi: 10.1155/2015/754626. Epub 2015 Dec 14. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	incidence of variation of oesophagus position before and after general anaesthesia	We use ultrasound to determine the position of osephagus (central or eccentric) to determine the incidence of variation of oesophagus position before and after general anaesthesia.	ultrasound assessment of position of oesophagus before and after general anaesthesia
Primary	The number of patients with eccentric oesophagus under general anesthesia, successfully occluded by using cricoid and paralaryngeal pressure.	we are studying the effectiveness of cricoid pressure versus cricoid and paralaryngeal pressure(novel technique) in those patients with eccentric oesophagus under general anaesthesia. We use ultrasound to determined the position of the oesophagus after patient under general anaethesia ( to group them under central oesophagus and eccentric oesophagus) and also to determine the success of oesophagus occlusion.	ultrasound assessment of oesophagus done after general anaesthesia, during application of cricoid pressure, and during application of cricoid and paralaryngeal pressure
Secondary	The number of patients with central oesophagus under general anesthesia, successfully occluded by using cricoid pressure.	The objective is to study the effectiveness of cricoid pressure in those patients with central oesophagus under general anaesthesia. We use ultrasound to determined the position of the oesophagus after patient under general anaethesia, and also to determine the success of oesophagus occlusion.	ultrasound assessment of oesophagus done after general anaesthesia and during application of cricoid pressure