Supreme LMA and Endotracheal Intubation Use in Caesarean Section

Wei Yu Yao920 enrolled

Overview

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%.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

920

Conditions

Complications; Cesarean Section

Interventions

Endotracheal intubationDEVICE

Portex endotracheal tube 6.5mm or 7.0mm internal diameter

Supreme Laryngeal Mask AirwayDEVICE

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

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

First attempt insertion success rate

An attempt is defined as insertion and complete withdrawal of the device from the patient's airway

Time frame: 1 hour

Secondary Outcomes

Time to effective airway placement

Interval from when the device was picked up until appearance of the first end-tidal carbon dioxide wave form

Time frame: 1 hour

Aspiration

Signs of aspiration as evidenced by perioperative hypoxemia, wheezing or crepitations upon auscultation of lungs or postoperative dyspnea with chest x ray signs of aspiration

Time frame: 1 hour

blood on SLMA on removal

inspection for presence of blood on Supreme Laryngeal Mask Airway on removal

Time frame: 1 hour

Sore Throat

Sore throat present in the postanaesthesia care unit

Time frame: 1 hour

Patient satisfaction

Patient satisfaction with whole anaesthetic experience at 24 hours postsurgery (0 to 100%)

Time frame: 1 hour

Regurgitation

Gastric contents identified in the mouth with pH less than 4

Time frame: 1 hour

Seal pressure

Recorded by closing the adjustable pressure limiting valve and insufflating the closed breathing system with 3L/min fresh gas flow. The peak circuit airway pressure achieved was recorded.

Data from ClinicalTrials.gov

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