Ambu® Auragain™ as a Conduit for Intubation in Paediatrics

August 3, 2020 updated by: Dr Lim Su Sian, University of Malaya

Clinical Evaluation of Ambu® Auragain™ as a Conduit for Intubation in Paediatrics

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Malaysia
      • Kuala Lumpur, Malaysia, 59100
        • University of Malaya

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 years to 12 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: OTHER
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: AMBU® AURAGAIN™ device
Assess feasibility of AMBU® AURAGAIN™ as an intubating device in paediatrics
Device: Intubation via AMBU® AURAGAIN™
Success rate of paediatric intubation through AMBU® AURAGAIN™
Other Names:
  • AMBU® AURAGAIN™
  • Supraglottic device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time taken to successful intubation via the Ambu® AuraGain™
Time Frame: Time taken during procedure ( measured in seconds )
Successful intubation is confirmed via the equal air entry heard bilaterally on auscultation and a positive capnograph tracing
Time taken during procedure ( measured in seconds )

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time taken required for removal of Ambu® AuraGain™ post intubation
Time Frame: Time taken during procedure ( measured in seconds )
Successful removal of device is confirmed by equal air entry heard bilaterally on auscultation and a positive capnograph tracing
Time taken during procedure ( measured in seconds )

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time required for insertion of Ambu® AuraGain™
Time Frame: Time taken during procedure ( measured in seconds )
Device insertion is limited to two attempts
Time taken during procedure ( measured in seconds )
Determine oropharyngeal leak pressure of Ambu® AuraGain™
Time Frame: Immediately post procedure- insertion of Ambu® AuraGain™ ( measured in mmHg )
Standard oropharyngeal leak test performed
Immediately post procedure- insertion of Ambu® AuraGain™ ( measured in mmHg )

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Malaya

Investigators

  • Study Chair: Ismiarti S Ina, MAnaes(UM), University of Malaya

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 1, 2019

Primary Completion (ACTUAL)

April 30, 2020

Study Completion (ACTUAL)

April 30, 2020

Study Registration Dates

First Submitted

May 8, 2019

First Submitted That Met QC Criteria

May 16, 2019

First Posted (ACTUAL)

May 17, 2019

Study Record Updates

Last Update Posted (ACTUAL)

August 5, 2020

Last Update Submitted That Met QC Criteria

August 3, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Auragain study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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