Supreme LMA and Endotracheal Intubation Use in Caesarean Section

Wei Yu Yao

Status: Completed

Conditions: Complications; Cesarean Section

Treatments: Device: Endotracheal intubation; Device: Supreme Laryngeal Mask Airway

Study type: Interventional

Funder types: Other

Identifiers

NCT01858467

2012-10-27

Details and patient eligibility

About

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%.

Full 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.

Enrollment: 920 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 to 50 years old
• ASA 1 or 2
• Fasted at least 6 hours
• Weight 40 to 75kg
• Normal airway assessment
• Singleton term pregnancy (>36weeks)
• Elective Caesarean section

Exclusion criteria

• In labour
• Body mass index >35
• Difficult airway (Mallampati 4 or abnormal airway assessment)
• Gastrooesophageal reflux disease

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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920 participants in 2 patient groups

Supreme Laryngeal Mask Airway

Experimental group

Description:

Supreme Laryngeal Mask Airway (Airway Device) with gastric tube. Preoxygenation, rapid sequence induction and cricoid pressure. Propofol 2 to 3mg/kg with 100mg succinylcholine. General anaesthesia with sevoflurane.

Treatment:

Device: Supreme Laryngeal Mask Airway

Endotracheal Intubation

Active Comparator group

Description:

Endotracheal intubation (Airway Device) using Macintosh Laryngoscope with tracheal tube with gastric tube insertion after placement. Preoxygenation, rapid sequence induction and cricoid pressure. Propofol 2 to 3mg/kg with 100mg succinylcholine. General anaesthesia with sevoflurane.

Treatment:

Device: Endotracheal intubation