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Completed

NCT Number: NCT04317976

Ultrasound Guided Cricoid and Paralaryngeal Pressure

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.

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Key information

Conditions

Ultrasonography, Interventional

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Malaya Medical Centre

Kuala Lumpur, 59100, Malaysia

About this study

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:

  • before induction of anaesthesia
  • after GA before external airway pressure manoeuvre
  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Elective list Under general anaesthesia Not intubated prior to OT

Exclusion criteria

Below 18 years old Pregnant Neck deformities Previous maxillofacial surgery

Treatment and study plan

paralaryngeal pressure

Other

cricoid pressure with paralaryngeal pressure by fingertips applied under ultrasound guidance

cricoid pressure

Other

cricoid pressure by fingertips applied under ultrasound guidance

Primary outcomes

  1. The number of patients with eccentric oesophagus under general anesthesia, successfully occluded by using cricoid and paralaryngeal pressure.

    Time frame: ultrasound assessment of oesophagus done after general anaesthesia, during application of cricoid pressure, and during application of 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.

Secondary outcomes

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

    Time frame: ultrasound assessment of oesophagus done after general anaesthesia and during application of 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.

Other outcomes

  1. incidence of variation of oesophagus position before and after general anaesthesia

    Time frame: ultrasound assessment of position of oesophagus 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.

Sponsors and collaborators

Lead sponsor

University of Malaya

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Mar 23, 2020
Registry last updated
Mar 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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