Ambu® Auragain™ as a Conduit for Intubation in Paediatrics
- Conditions
- Pediatric Endotracheal Intubation
- Interventions
- Device: Intubation via AMBU® AURAGAIN™
- Registration Number
- NCT03955094
- Lead Sponsor
- 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
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description AMBU® AURAGAIN™ device Intubation via AMBU® AURAGAIN™ Assess feasibility of AMBU® AURAGAIN™ as an intubating device in paediatrics
- Primary Outcome Measures
Name Time Method Time taken to successful intubation via the Ambu® AuraGain™ 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
Name Time Method Time taken required for removal of Ambu® AuraGain™ post intubation 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
Trial Locations
- Locations (1)
University of Malaya
🇲🇾Kuala Lumpur, Malaysia