Ambu® Auragain™ as a Conduit for Intubation in Paediatrics

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-01

Study Completion Date

2020-04-30

Brief Summary

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This study will be conducted as a prospective observational study

This study will be done in any of the operating theatres of University Malaya Medical Centre

This study will involve paediatric cases ( ages 3-12 years )posted for elective operations which require general anaesthesia with endotracheal intubation

Ambu Aura Gain will be used as a conduit for intubation

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Detailed Description

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All eligible participants will be approached and recruited Informed consent will be obtained Induction of general anesthesia will be as per usual standardized method Ambu® Auragain™ will be inserted A paediatric flexible endoscope will be used to view the glottis and railroad an endotracheal tube into the trachea Placement is confirmed and number of attempts and time required for successful intubation is recorded Ambu® Auragain™ will be removed Number of attempts and time taken for removal of Ambu® Auragain™ will be recorded Any complications will be noted and recorded

Conditions

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Pediatric Endotracheal Intubation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Prospective observational study All eligible patients will be approached and recruited All patients will be assigned to a single group - the use of AMBU® AURAGAIN™ as a conduit for flexible scope intubation No comparison groups

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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AMBU® AURAGAIN™ device

Assess feasibility of AMBU® AURAGAIN™ as an intubating device in paediatrics

Group Type EXPERIMENTAL

Intubation via AMBU® AURAGAIN™

Intervention Type DEVICE

Success rate of paediatric intubation through AMBU® AURAGAIN™

Interventions

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Intubation via AMBU® AURAGAIN™

Success rate of paediatric intubation through AMBU® AURAGAIN™

Intervention Type DEVICE

Other Intervention Names

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AMBU® AURAGAIN™ Supraglottic device

Eligibility Criteria

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Inclusion Criteria

* Paediatric patients aged 3 - 12 years old
* American Society of Anaesthesiologist (ASA) 1-2 patients
* Patients must require standard endotracheal intubation for the procedure posted

Exclusion Criteria

* Documented history of difficult airway in previous general anaesthesia
* Clinical features of difficult airway on physical examination
* Syndromic patients, facial deformities, dental deformities, patients with facial trauma
* Patients with recent (less than 2 weeks) or ongoing upper respiratory tract infection
* Patients with existing pulmonary diseases or any risk of bronchospasm
* Patients with known gastric outlet obstruction, reflux disease, or any risk of aspiration
* Any other contraindication for device placement
* Operations requiring specialised endotracheal tubes
* Emergency operations or unanticipated difficult airway cases
* Refusal of parental informed consent

Minimum Eligible Age

3 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes