The Accuracy of the Performance and Placement Test for Predicting Supraglottic Airway Device (SAD) Position in the Hypopharynx as Confirmed With Video Laryngoscopy

August 21, 2018 updated by: Dr Md Ariff bin Md Yusof, University of Malaya

The supraglottic airway device (SAD) is currently widely used in patients undergoing general anaesthesia as a method of securing the airway. The usage of SAD does not require the patient to be paralysed prior to insertion, as opposed to an endotracheal tube.

Five tests have been recommend to ensure that the SAD can be used for advanced procedure after a blind insertion. These tests however are not confirmed with visual validation and hence the confirmation of optimal position can be misleading.

This study is conducted to validate by video laryngoscopy the five recommended tests for confirming the placement and efficacy of a SAD, thus enabling its safe application in institutions with limited availability of video laryngoscopes.

Subjects for this study will consist of patients scheduled for procedures under general anaesthesia in the University of Malaya Medical Centre (UMMC) who are amenable to supraglottic airway management.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

The five tests are divided into placement and performance tests.

The placement tests are:-

  1. Suprasternal notch test: a gel plug is inserted in the proximal one centimetre of the gastric drain outlet. Gentle tapping of the suprasternal notch will cause the gel to pulsate. This confirms the location of the gastric outlet tip is behind the cricoid cartilage.
  2. Bubble test: when ventilating the SAD, the gel plug in the gastric drain outlet will not move. This confirms the location of the gastric outlet tip is behind the cricoid cartilage.
  3. Insertion of 14G gastric tube (Ryle's tube) into the gastric drain outlet. Ease of insertion grading:-

1 - Easy 2 - Difficult 3 - Impossible

Confirmation of correct gastric tube placement is through detection of injected air by auscultation of the epigastrium and/or aspiration of gastric contents.

The performance tests are:-

  1. Oropharyngeal Leak Pressure (OLP): measured by closing the adjustable pressure-limiting (APL) valve at 30cmH2O with a fresh gas flow of 3 L/min, noting the airway pressure at equilibrium or when there is an audible air leak detected from the throat.
  2. Maximum minute ventilation (MMV) test: performed by hand-ventilating the SAD with four maximal insufflations within 15 seconds (APL valve set to 30cmH2O) to obtain the exhaled tidal volume.

MMV (in L/min):- 4 x (breaths/15 seconds) x (exhaled tidal volume)

The visual-guided grading system for the placement of SAD is divided into optimal (Grade 1) and suboptimal (Grade 2 and 3) views.

Optimal view is recorded when the direct view of SAD in the hypopharynx fulfils all these conditions:-

  1. The epiglottis is in upright position
  2. The distal cuff of SAD is in the oesophagus
  3. The rim of proximal cuff and tip of epiglottis is aligned
  4. The epiglottis is resting on outside of the proximal cuff
  5. The proximal cuff is fully deployed after cuff inflation

Suboptimal view is recorded when the direct view of SAD in the hypopharynx follows these conditions:-

  1. The epiglottis is downfolded or folded sideways
  2. The distal cuff is folded over backwards or the distal cuff is between and across the vocal cords
  3. The rim of proximal cuff and the tip of the epiglottis are not aligned
  4. The epiglottis is sitting in the bowl of the SAD
  5. The proximal cuff is distorted after cuff inflation

Study Type

Interventional

Enrollment (Anticipated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patients scheduled for procedures under general anaesthesia in the University of Malaya Medical Centre (UMMC) who are amenable to supraglottic airway management.

Exclusion Criteria:

  1. - American Society of Anesthesiologists (ASA) physical status class IV and above
  2. - morbid obesity (BMI > 40kg/m2)
  3. - high risk of regurgitation or aspiration (e.g. symptomatic gastro-oesophageal reflux, hiatus hernia)
  4. - respiratory tract pathology (e.g. preoperative sore throat)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To evaluate the accuracy of the performance and placement tests for predicting SAD position in the hypopharynx as confirmed with video laryngoscopy
Time Frame: Intraoperative (from commencement of SAD insertion until confirmation of satisfactory SAD placement via video-laryngoscopy)
If all five placement and performance tests are successful, optimal (Grade 1) view of the SAD from video-laryngoscopy is expected.
Intraoperative (from commencement of SAD insertion until confirmation of satisfactory SAD placement via video-laryngoscopy)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Malaya

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

September 1, 2018

Primary Completion (ANTICIPATED)

December 1, 2019

Study Completion (ANTICIPATED)

June 1, 2020

Study Registration Dates

First Submitted

August 20, 2018

First Submitted That Met QC Criteria

August 21, 2018

First Posted (ACTUAL)

August 22, 2018

Study Record Updates

Last Update Posted (ACTUAL)

August 23, 2018

Last Update Submitted That Met QC Criteria

August 21, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Other Study ID Numbers

  • 2018517-6295

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Sharing Time Frame

From date of publication until seven years after publication

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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