Ambu® Auragain™ as a Conduit for Intubation in Paediatrics

Pediatric Endotracheal Intubation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03955094
• Other study ID #: Auragain study
• Status: Completed
• Phase: N/A
• Start date: November 1, 2019
• Est. completion date: April 30, 2020

Study information

• Verified date: August 2020
• Source: University of Malaya
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: April 30, 2020
• Est. primary completion date: April 30, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 3 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Pediatric Endotracheal Intubation

Intervention

Device:
• Intubation via AMBU® AURAGAIN™
Success rate of paediatric intubation through AMBU® AURAGAIN™

Locations

Country	Name	City	State
Malaysia	University of Malaya	Kuala Lumpur

Sponsors (1)

Lead Sponsor	Collaborator
University of Malaya

Country where clinical trial is conducted

Malaysia, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

Jagannathan N, Sohn LE, Sawardekar A, Gordon J, Shah RD, Mukherji II, Roth AG, Suresh S. A randomized trial comparing the Ambu ® 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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Time required for insertion of Ambu® AuraGain™	Device insertion is limited to two attempts	Time taken during procedure ( measured in seconds )
Other	Determine oropharyngeal leak pressure of Ambu® AuraGain™	Standard oropharyngeal leak test performed	Immediately post procedure- insertion of Ambu® AuraGain™ ( measured in mmHg )
Primary	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 taken during procedure ( measured in seconds )
Secondary	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 taken during procedure ( measured in seconds )