Supreme LMA and Endotracheal Intubation Use in Caesarean Section

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

920 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-05-31

Study Completion Date

2014-07-31

Brief Summary

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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%.

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Detailed Description

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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

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Complications; Cesarean Section

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Supreme Laryngeal Mask Airway

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.

Group Type EXPERIMENTAL

Supreme Laryngeal Mask Airway

Intervention Type DEVICE

Supreme Laryngeal Mask Airway Size 3 or Size 4 with gastric tube insertion.

Endotracheal Intubation

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.

Group Type ACTIVE_COMPARATOR

Endotracheal intubation

Intervention Type DEVICE

Portex endotracheal tube 6.5mm or 7.0mm internal diameter

Interventions

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Endotracheal intubation

Portex endotracheal tube 6.5mm or 7.0mm internal diameter

Intervention Type DEVICE

Supreme Laryngeal Mask Airway

Supreme Laryngeal Mask Airway Size 3 or Size 4 with gastric tube insertion.

Intervention Type DEVICE

Eligibility Criteria

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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