Comparing Between Air-Q Intubating Laryngeal Airway and Ambu® AuraGain™

NCT03130413 | Completed DMC

• 1 other identifier: USM/JEPeM/15110476
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

The aim of this randomized study is conducted is to evaluate the performance and safety of air-Q intubating laryngeal airway as primary airway device in various short surgical procedure in children compared to Ambu® AuraGain™ Laryngeal Mask. Current Supraglottic airway devices (SADs) available in are classic LMA (cLMA), proseal LMA (pLMA), supreme LMA (sLMA) and the newer is Ambu® AuraGain™laryngeal mask. As variety of newer SADs for children have emerged since their introduction in clinical practice, hope the outcomes of this study it help advancing our knowledge and acumen in selecting appropriate devices for paediatric population.

Conditions

General Anaesthesia

Keywords

Ambu Aura Gain; Air-Q intubating laryngeal airway; Paediatric surgery

Outcome Measures

Primary Outcomes (1)

• measure fibreoptic (FO) grade of laryngeal view

  Flexible fibreoptic scope is use to view anatomical alignment of the device to the larynx, 1cm proximal to the ventilating orifice

  5 minutes after insertion of the device when good tidal volume is achieved

Secondary Outcomes (8)

• oropharyngeal leak pressure (OLP)

  5 minutes after insertion of the device when good tidal volume is achieved

• number of attempt

  Throughout the insertion process up to 5 minutes post induction

• Time of insertion

  The time from which the device first being hold until successful insertion up to 5 minutes post induction

• Blood pressure

  Time from pre-induction until 5 minutes post insertion

• Heart rate

  Time from pre-induction until 5 minutes post insertion

Study Arms (2)

Ambu Aura Gain

EXPERIMENTAL

Ambu Aura Gain supraglottic airway size 2 or 2.5 will be inserted once patients are paralyzed

Device: Ambu Aura Gain supraglottic airway

Air-Q

ACTIVE COMPARATOR

Air-Q supraglottic airway size 1.5 and 2.0will be inserted once the patients are paralyzed

Device: Air-Q supraglottic airway

Interventions

Ambu Aura Gain supraglottic airway DEVICE

Anesthesia is induced with sevoflurane in oxygen. The anesthesia plane is gradually deepened by increasing the inspired concentration of sevoflurane (2-8%) till the loss of eyelash reflex. After intravenous (IV) cannula is inserted and intravenous fentanyl 1mcg/kg and rocuronium 0.6mg/kg are administered. Use of neuromuscular blocking agent is to minimize the risk of reflex activation of the airway. After 3 minutes, the appropriate size (depending upon body weight) of Ambu Aura Gain is lubricated with water soluble lubricant (KY jelly) is inserted by investigator based on manufacturer recommendation with the patient's head in neutral position. The cuff then is inflated to an intra-cuff pressure of 40 cm H20, measured using a digital cuff pressure monitor.

Ambu Aura Gain

Air-Q supraglottic airway DEVICE

Anesthesia is induced with sevoflurane in oxygen. The anesthesia plane is gradually deepened by increasing the inspired concentration of sevoflurane (2-8%) till the loss of eyelash reflex. After intravenous (IV) cannula is inserted and intravenous fentanyl 1mcg/kg and rocuronium 0.6mg/kg are administered. Use of neuromuscular blocking agent is to minimize the risk of reflex activation of the airway. After 3 minutes, the appropriate size (depending upon body weight) of Air-Q supraglottic airway is lubricated with water soluble lubricant (KY jelly) is inserted by investigator based on manufacturer recommendation with the patient's head in neutral position. The cuff then is inflated to an intra-cuff pressure of 40 cm H20, measured using a digital cuff pressure monitor.

Air-Q

Eligibility Criteria

• Age: 1 Year - 6 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• Age between 1-6 years
• Weight 10-30kg
• American Society of Anesthesiologist (ASA) physical status class I and II
• Any surgical procedures where supraglottic airway (SGA) management is appropriate
• Duration of procedure within 2hours

You may not qualify if:

• Active respiratory infection
• Anticipated and known difficult airway
• Lung disease requiring high airway pressure

Sponsors & Collaborators

• Universiti Sains Malaysia: lead
• Ambu A/S: collaborator

Study Sites (1)

University of Science Malaysia Hospital

Kubang Kerian, Kelantan, 16150, Malaysia

Location

Related Publications (4)

• Darlong V, Biyani G, Baidya DK, Pandey R, Chandralekha, Punj J, Upadhyay AD. Comparison of air-Q and Ambu Aura-i for controlled ventilation in infants: a randomized controlled trial. Paediatr Anaesth. 2015 Aug;25(8):795-800. doi: 10.1111/pan.12663. Epub 2015 Apr 27.

  PMID: 25917434 RESULT

• Darlong V, Biyani G, Pandey R, Baidya DK, Punj Ca. Comparison of performance and efficacy of air-Q intubating laryngeal airway and flexible laryngeal mask airway in anesthetized and paralyzed infants and children. Paediatr Anaesth. 2014 Oct;24(10):1066-71. doi: 10.1111/pan.12462.

  PMID: 24961960 RESULT

• Jagannathan N, Hajduk J, Sohn L, Huang A, Sawardekar A, Gebhardt ER, Johnson K, De Oliveira GS. A randomised comparison of the Ambu(R) AuraGain and the LMA(R) supreme in infants and children. Anaesthesia. 2016 Feb;71(2):205-12. doi: 10.1111/anae.13330. Epub 2015 Dec 9.

  PMID: 26648173 RESULT

• Whyte SD, Cooke E, Malherbe S. Usability and performance characteristics of the pediatric air-Q(R) intubating laryngeal airway. Can J Anaesth. 2013 Jun;60(6):557-63. doi: 10.1007/s12630-013-9918-6. Epub 2013 Mar 22.

  PMID: 23519724 RESULT

Study Officials

• Rhendra Hardy Mohamad Zaini, MD

  Universiti of Science Malaysia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: April 2, 2017
• First Posted: April 26, 2017
• Study Start: November 1, 2016
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2018
• Last Updated: June 1, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

MY (1)