CompletedNCT03955094Updated Aug 5, 2020

Ambu® Auragain™ as a Conduit for Intubation in Paediatrics

An interventional study of Intubation via AMBU® AURAGAIN™ in Pediatric Endotracheal Intubation, sponsored by University of Malaya. Completed at 1 site in Malaysia. Open to participants aged 3 Years to 12 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-08-05.

Sponsored by University of Malaya · Not applicable, Interventional, and Other

Phase: Not applicable
Study type: Interventional
Enrollment: 16
Allocation: Not applicable
Ages: 3 Years to 12 Years
Sex: All

Study 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

Read the 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

Conditions studied

Pediatric Endotracheal Intubation

Keywords

AMBU® AURAGAIN™
intubation in paediatrics
flexible scope guided intubation
success rate of intubation
glottic view
supraglottic airway intubation
efficacy safety

In context

Lead sponsor

University of Malaya is the lead sponsor of 280 studies on the registry; 55 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 3 Years to 12 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

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

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 design

Phase: Not applicable
Primary purpose: Other
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 16 participants (actual)

Study arms

Experimental
AMBU® AURAGAIN™ device
Assess feasibility of AMBU® AURAGAIN™ as an intubating device in paediatrics
Device: Intubation via AMBU® AURAGAIN™

Interventions

DeviceIntubation via AMBU® AURAGAIN™
Success rate of paediatric intubation through AMBU® AURAGAIN™
Also known as: AMBU® AURAGAIN™, Supraglottic device

What researchers measure

Primary outcomes

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

Secondary outcomes

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

Other outcomes

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

Study locations

1 site

University of Malaya
Kuala Lumpur, 59100, Malaysia

References and documents

Publications

Sinha R, Chandralekha, Ray BR. Evaluation of air-Q intubating laryngeal airway as a conduit for tracheal intubation in infants--a pilot study. Paediatr Anaesth. 2012 Feb;22(2):156-60. doi: 10.1111/j.1460-9592.2011.03710.x. PubMed 21973052 ↗
Pandey RK, Subramanium RK, Darlong V, Lekha C, Garg R, Punj J, Rewari V, Bajpai M. Evaluation of glottic view through Air-Q Intubating Laryngeal Airway in the supine and lateral position and assessing it as a conduit for blind endotracheal intubation in children in the supine position. Paediatr Anaesth. 2015 Dec;25(12):1241-7. doi: 10.1111/pan.12746. Epub 2015 Sep 29. PubMed 26417722 ↗
Jagannathan N, Kozlowski RJ, Sohn LE, Langen KE, Roth AG, Mukherji II, Kho MF, Suresh S. A clinical evaluation of the intubating laryngeal airway as a conduit for tracheal intubation in children. Anesth Analg. 2011 Jan;112(1):176-82. doi: 10.1213/ANE.0b013e3181fe0408. Epub 2010 Nov 16. PubMed 21081777 ↗
Jagannathan N, Sohn LE, Sawardekar A, Gordon J, Shah RD, Mukherji II, Roth AG, Suresh S. A randomized trial comparing the Ambu (R) Aura-i with the air-Q intubating laryngeal airway as conduits for tracheal intubation in children. Paediatr Anaesth. 2012 Dec;22(12):1197-204. doi: 10.1111/pan.12024. Epub 2012 Sep 13. PubMed 22971118 ↗
Jagannathan N, Sohn L, Ramsey M, Huang A, Sawardekar A, Sequera-Ramos L, Kromrey L, De Oliveira GS. A randomized comparison between the i-gel and the air-Q supraglottic airways when used by anesthesiology trainees as conduits for tracheal intubation in children. Can J Anaesth. 2015 Jun;62(6):587-94. doi: 10.1007/s12630-014-0304-9. Epub 2014 Dec 24. PubMed 25537736 ↗
Girgis KK, Youssef MM, ElZayyat NS. Comparison of the air-Q intubating laryngeal airway and the cobra perilaryngeal airway as conduits for fiber optic-guided intubation in pediatric patients. Saudi J Anaesth. 2014 Oct;8(4):470-6. doi: 10.4103/1658-354X.140841. PubMed 25422603 ↗

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Aug 5, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT03955094
Lead sponsor: University of Malaya
Responsible party: Dr Lim Su Sian (Medical officer UD 48, University of Malaya) — Principal investigator
First posted: May 17, 2019
Start date: Nov 1, 2019
Primary completion: Apr 30, 2020
Completion: Apr 30, 2020
Last update: Aug 5, 2020

Study contacts

Ismiarti S Ina, MAnaes(UM)

study chair · University of Malaya

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

University of Malaya

Start the discussion