Ultrasound Guided Cricoid and Paralaryngeal Pressure

NCT ID: NCT04317976

Last Updated: 2020-03-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

51 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-01

Study Completion Date

2019-07-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Ultrasonography, Interventional

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

The study is a case-control intervention study, where all and every participant will be both the case and the control of their own.
Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers
Participant will not be informed of their anatomical details. Care provider will not be informed of their accuracy of performance of the airway manoeuvre.

Study Groups

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Centrally located oesophagus post GA

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

Group Type ACTIVE_COMPARATOR

cricoid pressure

Intervention Type OTHER

cricoid pressure by fingertips applied under ultrasound guidance

Eccentric located oesophagus post GA

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

Group Type EXPERIMENTAL

paralaryngeal pressure

Intervention Type OTHER

cricoid pressure with paralaryngeal pressure by fingertips applied under ultrasound guidance

Interventions

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paralaryngeal pressure

cricoid pressure with paralaryngeal pressure by fingertips applied under ultrasound guidance

Intervention Type OTHER

cricoid pressure

cricoid pressure by fingertips applied under ultrasound guidance

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

Elective list Under general anaesthesia Not intubated prior to OT

Exclusion Criteria

Below 18 years old Pregnant Neck deformities Previous maxillofacial surgery
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Malaya

OTHER

Sponsor Role lead

Responsible Party

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Dr Lim Siu Min

Dr,

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Siu Min Lim, M. Anaes

Role: PRINCIPAL_INVESTIGATOR

University of Malaya

Locations

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University Malaya Medical Centre

Kuala Lumpur, , Malaysia

Site Status

Countries

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Malaysia

References

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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.

Reference Type BACKGROUND
PMID: 30044502 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 19843793 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27523050 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23263978 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26788507 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24574584 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28602458 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12826843 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 11983669 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 13749923 (View on PubMed)

Other Identifiers

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45835

Identifier Type: OTHER

Identifier Source: secondary_id

2018118-6867

Identifier Type: -

Identifier Source: org_study_id

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