Ultrasound Guided Cricoid and Paralaryngeal Pressure

NCT04317976 | Completed

• 2 other identifiers: 2018118-686745835
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ultrasonography, Interventional

Keywords

Anatomy; oesophagus; ultrasound; incidence; cricoid; paralaryngeal

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• The number of patients with central oesophagus under general anesthesia, successfully occluded by using cricoid pressure.

  ultrasound assessment of oesophagus done after general anaesthesia and during application of cricoid pressure

Other Outcomes (1)

• incidence of variation of oesophagus position before and after general anaesthesia

  ultrasound assessment of position of oesophagus before and after general anaesthesia

Study Arms (2)

Centrally located oesophagus post GA

ACTIVE COMPARATOR

Oesophagus remained central after general anaesthesia, cricoid pressure applied by fingertips under ultrasound guidance

Other: cricoid pressure

Eccentric located oesophagus post GA

EXPERIMENTAL

Oesophagus eccentric located after general anaesthesia, paralaryngeal pressure and cricoid pressure applied by fingertips under ultrasound guidance

Other: paralaryngeal pressure

Interventions

paralaryngeal pressure OTHER

cricoid pressure with paralaryngeal pressure by fingertips applied under ultrasound guidance

Eccentric located oesophagus post GA

cricoid pressure OTHER

cricoid pressure by fingertips applied under ultrasound guidance

Centrally located oesophagus post GA

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Elective list Under general anaesthesia Not intubated prior to OT

You may not qualify if:

• Below 18 years old Pregnant Neck deformities Previous maxillofacial surgery

Sponsors & Collaborators

• University of Malaya: lead

Study Sites (1)

University Malaya Medical Centre

Kuala Lumpur, 59100, Malaysia

Location

Related Publications (10)

• 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.

  PMID: 30044502 BACKGROUND

• 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.

  PMID: 19843793 BACKGROUND

• 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.

  PMID: 27523050 BACKGROUND

• 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. No abstract available.

  PMID: 23263978 BACKGROUND

• Votruba J, Zemanova 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.

  PMID: 26788507 BACKGROUND

• 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.

  PMID: 24574584 BACKGROUND

• 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.

  PMID: 28602458 BACKGROUND

• 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. doi: 10.1097/00000542-200307000-00013.

  PMID: 12826843 BACKGROUND

• 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. doi: 10.1007/BF03017931.

  PMID: 11983669 BACKGROUND

• SELLICK BA. Cricoid pressure to control regurgitation of stomach contents during induction of anaesthesia. Lancet. 1961 Aug 19;2(7199):404-6. doi: 10.1016/s0140-6736(61)92485-0. No abstract available.

  PMID: 13749923 BACKGROUND

Study Officials

• Siu Min Lim, M. Anaes

  University of Malaya

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Participant will not be informed of their anatomical details. Care provider will not be informed of their accuracy of performance of the airway manoeuvre.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr,

Model Details: The study is a case-control intervention study, where all and every participant will be both the case and the control of their own.

Study Record Dates

• First Submitted: November 9, 2019
• First Posted: March 23, 2020
• Study Start: February 1, 2019
• Primary Completion: May 30, 2019
• Study Completion: July 31, 2019
• Last Updated: March 23, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)