NCT01858467

Supreme LMA and Endotracheal Intubation Use in Caesarean Section

Supreme LMA Versus Endotracheal Intubation in General Anaesthesia for Elective Caesarean Section- a Randomised Controlled Trial

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 920 (actual)
• Sponsor: Wei Yu Yao · Academic / Other
• Sex: Female
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The LMA Supreme (SLMA) is a single-use supraglottic device that provides a good seal for positive pressure ventilation and good first attempt insertion rate of 98% in low-risk patients undergoing Caesarean section. It has a double aperture design that facilitates the introduction of an orogastric tube to aspirate gastric contents. The current practice is to use endotracheal intubation with rapid sequence induction in general anaesthesia for Caesarean section. The primary study hypothesis is the first attempt insertion success rate of SLMA and endotracheal intubation are equivalent with a difference of less than 3%.

Detailed description

We propose a randomised controlled trial to study the first attempt insertion success rate of supreme LMA versus endotracheal intubation in general anaesthesia for elective Caesarean section.

Conditions

• Complications; Cesarean Section

Interventions

Type	Name	Description
DEVICE	Endotracheal intubation	Portex endotracheal tube 6.5mm or 7.0mm internal diameter
DEVICE	Supreme Laryngeal Mask Airway	Supreme Laryngeal Mask Airway Size 3 or Size 4 with gastric tube insertion.

Timeline

• Start date: 2013-05-01
• Primary completion: 2014-07-01
• Completion: 2014-07-01
• First posted: 2013-05-21
• Last updated: 2018-05-07