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General AnesthesiaNCT03643029

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

A study testing Video-laryngoscopy following SAD insertion in people with General Anesthesia and Supraglottic Airway Device, run by University of Malaya.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Any age
What is being tested?
Video-laryngoscopy following SAD insertion
Type of treatment
Medical device
How many people
50 participants
Where
No sites listed yet
Study dates
Sep 2018to Jun 2020
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

No sites are listed yet.

Md Ariff Md Yusof, Dr contact

+6012-6066704

mamy2517@yahoo.com

About this study

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.

Read more

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.

Read the 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
Being tested
Video-laryngoscopy following SAD insertion

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Video-laryngoscopy following SAD insertionDevice

    Following insertion of a supraglottic airway device (SAD), the placement and performance tests are carried out. If the tests are successful, a video-laryngoscopy will be performed to confirm the placement of the SAD in the hypopharynx.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. To evaluate the accuracy of the performance and placement tests for predicting SAD position in the hypopharynx as confirmed with video laryngoscopy

    If all five placement and performance tests are successful, optimal (Grade 1) view of the SAD from video-laryngoscopy is expected.

    Measured: Intraoperative (from commencement of SAD insertion until confirmation of satisfactory SAD placement via video-laryngoscopy)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted22 Aug 2018
  2. Study startSep 2018 (estimated)
  3. Primary completionDec 2019 (estimated)
  4. Study completionJun 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
50 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03643029
Sponsor's protocol ID
2018517-6295
Status last verified
Aug 2018
First submitted
20 Aug 2018
Last updated
23 Aug 2018
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes

Publications

  • Timmermann A, Bergner UA, Russo SG. Laryngeal mask airway indications: new frontiers for second-generation supraglottic airways. Curr Opin Anaesthesiol. 2015 Dec;28(6):717-26. doi: 10.1097/ACO.0000000000000262.

    PubMed 26539790

  • Van Zundert AAJ, Gatt SP, Kumar CM, Van Zundert TCRV, Pandit JJ. 'Failed supraglottic airway': an algorithm for suboptimally placed supraglottic airway devices based on videolaryngoscopy. Br J Anaesth. 2017 May 1;118(5):645-649. doi: 10.1093/bja/aex093. No abstract available.

    PubMed 28510747

  • Chaw SH, Shariffuddin II, Md Yusof MA, Wong CW, Ruslan SR, Hussain NA, Zainal Abidin MF, van Zundert A. Predicting optimal supraglottic airway device placement: do placement and performance tests measure up? BMC Anesthesiol. 2025 Oct 14;25(1):494. doi: 10.1186/s12871-025-03278-6.

    PubMed 41087887

Questions about this trial

What is this clinical trial studying?

A study testing Video-laryngoscopy following SAD insertion in people with General Anesthesia and Supraglottic Airway Device, run by University of Malaya.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 23 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Md Ariff Md Yusof, Dr (+6012-6066704, mamy2517@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

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)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03643029, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2018.

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