Laryngeal Mask Airway
Conditions
Brief summary
The investigators conduct this study to evaluate the clinical efficacy of size 1 and 1.5 supreme LMA compared to proseal LMA for infants weighing \<10kg.
Detailed description
This is a randomized prospective study to compare the clinical efficacy and safety for size 1 and 1.5 LMA supreme and LMA Proseal. The airway leak pressure of these 2 devices will be compared and other parameters such as time to insertion, insertion success rate, fibreoptic glottic view and intraoperative complications will be recorded.
Interventions
DEVICELMA Supreme
The device will be inserted according to manufacturer's guideline. Time of insertion will be recorded. The oropharyngeal airway leak pressure will be measured when the device successfully inserted. The time taken to insert the LMA is recorded and the insertion success rate is documented. The larynx will be visualized with fibreoptic bronchoscope inserted through the LMA. Intraoperative complications will be recorded.
DEVICELMA Proseal
The device will be inserted according to manufacturer's guideline. Time of insertion will be recorded. The oropharyngeal airway leak pressure will be measured when the device successfully inserted. The time taken to insert the LMA is recorded and the insertion success rate is documented. The larynx will be visualized with fibreoptic bronchoscope inserted through the LMA. Intraoperative complications will be recorded.
Sponsors
University of Malaya
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
2 Months to 2 Years
Healthy volunteers
No
Inclusion criteria
* Weight of \< 10kg * ASA (American Society of Anesthesiologists) I-II * Infants undergoing elective surgery under general anaesthesia using supraglottic airway device. * Informed consent obtained from parents.
Exclusion criteria
* ASA III-IV and emergency surgery * Neonates and ex-premature babies with post conceptual age \<55 weeks. * Infants with history of difficult airway. * Infants with features of difficult intubation. * Active upper respiratory tract infection * Infants with pulmonary disease * Infants with history of gastroesophageal reflux disease * Infants with risks of regurgitation and aspiration.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Oropharyngeal leak pressure | intraoperative | The measurement of oropharyngeal airway pressure when airway leak occurred |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Insertion success rate | intraoperative | The number of attempts for successful placement of the supraglottic airway is recorded. |
| Fibreoptic glottis view | intraoperative | Fibreoptic glottis view will be recorded according to a grading system |
| Intraoperative complications | intraoperative | Complications such as loss of airway patency, desaturation, regurgitation of gastric contents, laryngospasm, bronchospasm and airway trauma will be recorded |
| Time to insertion | intraoperative | Time from picking up the supraglottic airway device to the first detection of capnography square wave |
Countries
Malaysia
Outcome results
None listed