A Randomized Comparison of LMA (Laryngeal Mask Airway) Supreme and LMA Proseal in Infants Below 10kg

University of Malaya

Status: Completed

Conditions: Laryngeal Mask Airway

Treatments: Device: LMA Supreme; Device: LMA Proseal

Study type: Interventional

Funder types: Other

Identifiers

NCT02478983

995.7

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 2 months to 2 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

60 participants in 2 patient groups

LMA Supreme

Experimental group

Description:

1 arm will receive LMA supreme for airway management

Treatment:

Device: LMA Supreme

LMA Proseal

Active Comparator group

Description:

1 arm will receive LMA Proseal for airway management

Treatment:

Device: LMA Proseal