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Ambu® Auragain™ as a Conduit for Intubation in Paediatrics

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ClinicalTrials.gov Identifier: NCT03955094
Recruitment Status : Not yet recruiting
First Posted : May 17, 2019
Last Update Posted : May 17, 2019
Sponsor:
Information provided by (Responsible Party):
Dr Lim Su Sian, University of Malaya

Brief Summary:

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


Condition or disease Intervention/treatment Phase
Pediatric Endotracheal Intubation Device: Intubation via AMBU® AURAGAIN™ Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 41 participants
Intervention Model: Single Group Assignment
Intervention Model Description: 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
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Clinical Evaluation of Ambu® Auragain™ as a Conduit for Intubation in Paediatrics
Estimated Study Start Date : June 1, 2019
Estimated Primary Completion Date : May 31, 2020
Estimated Study Completion Date : December 31, 2020

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Other Outcome Measures:
  1. Time required for insertion of Ambu® AuraGain™ [ Time Frame: Time taken during procedure ( measured in seconds ) ]
    Device insertion is limited to two attempts

  2. Determine oropharyngeal leak pressure of Ambu® AuraGain™ [ Time Frame: Immediately post procedure- insertion of Ambu® AuraGain™ ( measured in mmHg ) ]
    Standard oropharyngeal leak test performed



Information from the National Library of Medicine

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Ages Eligible for Study:   3 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03955094


Contacts
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Contact: Su S Lim, M.D (UCSI) +60173391367 ssletterbox@hotmail.com
Contact: Ismiarti S Ina, MAnaes(UM) +60122353134 ismiarti@ummc.edu.my

Locations
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Malaysia
University of Malaya Not yet recruiting
Kuala Lumpur, Malaysia, 59100
Contact: Ismiarti S Ina, MAnaes(UM)    +60122353134    ismiarti@ummc.edu.my   
Contact: Kevin WS Ng, MAnaes(UM)    +60122987708    kevin.ng@ummc.edu.my   
Sponsors and Collaborators
University of Malaya
Investigators
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Study Chair: Ismiarti S Ina, MAnaes(UM) University of Malaya

Publications:

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Responsible Party: Dr Lim Su Sian, Medical officer UD 48, University of Malaya
ClinicalTrials.gov Identifier: NCT03955094     History of Changes
Other Study ID Numbers: Auragain study
First Posted: May 17, 2019    Key Record Dates
Last Update Posted: May 17, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dr Lim Su Sian, University of Malaya:
AMBU® AURAGAIN™
intubation in paediatrics
flexible scope guided intubation
success rate of intubation
glottic view
supraglottic airway intubation
efficacy safety