General Anaesthesia Clinical Trial
— NiraOfficial title:
Comparing the Effectiveness Between Air-Q Intubating Laryngeal Airway and Ambu® AuraGain™ Laryngeal Mask for Controlled Ventilation in Paediatric Patients: A Randomized Controlled Trial.
Verified date | May 2018 |
Source | University of Science Malaysia |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of this randomized study is conducted is to evaluate the performance and safety of air-Q intubating laryngeal airway as primary airway device in various short surgical procedure in children compared to Ambu® AuraGain™ Laryngeal Mask. Current Supraglottic airway devices (SADs) available in are classic LMA (cLMA), proseal LMA (pLMA), supreme LMA (sLMA) and the newer is Ambu® AuraGain™laryngeal mask. As variety of newer SADs for children have emerged since their introduction in clinical practice, hope the outcomes of this study it help advancing our knowledge and acumen in selecting appropriate devices for paediatric population.
Status | Completed |
Enrollment | 64 |
Est. completion date | June 1, 2018 |
Est. primary completion date | June 1, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 1 Year to 6 Years |
Eligibility |
Inclusion Criteria: - Age between 1-6 years - Weight 10-30kg - American Society of Anesthesiologist (ASA) physical status class I and II - Any surgical procedures where supraglottic airway (SGA) management is appropriate - Duration of procedure within 2hours Exclusion Criteria: - Active respiratory infection - Anticipated and known difficult airway - Lung disease requiring high airway pressure |
Country | Name | City | State |
---|---|---|---|
Malaysia | University of Science Malaysia Hospital | Kubang Kerian | Kelantan |
Lead Sponsor | Collaborator |
---|---|
University of Science Malaysia | Ambu A/S |
Malaysia,
Darlong V, Biyani G, Baidya DK, Pandey R, Chandralekha, Punj J, Upadhyay AD. Comparison of air-Q and Ambu Aura-i for controlled ventilation in infants: a randomized controlled trial. Paediatr Anaesth. 2015 Aug;25(8):795-800. doi: 10.1111/pan.12663. Epub 2 — View Citation
Darlong V, Biyani G, Pandey R, Baidya DK, Punj Ca. Comparison of performance and efficacy of air-Q intubating laryngeal airway and flexible laryngeal mask airway in anesthetized and paralyzed infants and children. Paediatr Anaesth. 2014 Oct;24(10):1066-71 — View Citation
Jagannathan N, Hajduk J, Sohn L, Huang A, Sawardekar A, Gebhardt ER, Johnson K, De Oliveira GS. A randomised comparison of the Ambu® AuraGain™ and the LMA® supreme in infants and children. Anaesthesia. 2016 Feb;71(2):205-12. doi: 10.1111/anae.13330. Epub — View Citation
Whyte SD, Cooke E, Malherbe S. Usability and performance characteristics of the pediatric air-Q® intubating laryngeal airway. Can J Anaesth. 2013 Jun;60(6):557-63. doi: 10.1007/s12630-013-9918-6. Epub 2013 Mar 22. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | measure fibreoptic (FO) grade of laryngeal view | Flexible fibreoptic scope is use to view anatomical alignment of the device to the larynx, 1cm proximal to the ventilating orifice | 5 minutes after insertion of the device when good tidal volume is achieved | |
Secondary | oropharyngeal leak pressure (OLP) | OLP is recorded by observing the peak airway pressure which audible leak occur at the first time when fresh gas flow delivered at 3 litre/min and the expiratory valve is completely closed | 5 minutes after insertion of the device when good tidal volume is achieved | |
Secondary | number of attempt | Measure number of attempts of inserting the devices | Throughout the insertion process up to 5 minutes post induction | |
Secondary | Time of insertion | Measure the time of successful insertion of the devices | The time from which the device first being hold until successful insertion up to 5 minutes post induction | |
Secondary | Blood pressure | Documented the blood pressure (BP) is recorded at different time interval | Time from pre-induction until 5 minutes post insertion | |
Secondary | Heart rate | Recorded the heart rate (HR) is recorded at different interval | Time from pre-induction until 5 minutes post insertion | |
Secondary | Oxygen saturation (SpO2) | Oxygen saturation (SpO2) is recorded at different interval | Time from pre-induction until 5 minutes post insertion | |
Secondary | end tidal Carbon dioxide (EtCO2) | The EtCO2 is recorded at different time interval | Time from pre-induction until 5 minutes post insertion | |
Secondary | numbers of adverse effects of the devices as assessed by clinical observation | Presence of adverse effect of the device postextubation | Throughout the stay in recovery bay within 30 minutes after operation |
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