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

NCT03130413 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 64

Last updated 2018-06-01

No results posted yet for this study

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

Interventions

DEVICE

Ambu Aura Gain supraglottic airway

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.

DEVICE

Air-Q supraglottic airway

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.

Sponsors & Collaborators

  • Ambu A/S

    collaborator INDUSTRY

  • Universiti Sains Malaysia

    lead OTHER

Principal Investigators

  • Rhendra Hardy Mohamad Zaini, MD · Universiti of Science Malaysia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
1 Year
Max Age
6 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-11-30
Primary Completion
2018-06-01
Completion
2018-06-01

Countries

  • Malaysia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03130413 on ClinicalTrials.gov