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

NCT03643029 | Unknown

• 1 other identifier: 2018517-6295
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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. 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.

Conditions

General Anesthesia; Supraglottic Airway Device; Laryngeal Mask Airway

Outcome Measures

Primary Outcomes (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.

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

Interventions

Video-laryngoscopy following SAD insertion DEVICE

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.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• \- 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)

Sponsors & Collaborators

• University of Malaya: lead

Related Publications (2)

• 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.

  PMID: 26539790 BACKGROUND

• 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.

  PMID: 28510747 BACKGROUND

Central Study Contacts

Md Ariff Md Yusof, Dr

CONTACT

+6012-6066704; mamy2517@yahoo.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Officer

Study Record Dates

• First Submitted: August 20, 2018
• First Posted: August 22, 2018
• Study Start: September 1, 2018
• Primary Completion: December 1, 2019
• Study Completion: June 1, 2020
• Last Updated: August 23, 2018

Record last verified: 2018-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: From date of publication until seven years after publication