Supreme LMA Use in Urgent Caesarean Section

N/ACompletedNCT02026882

QuanZhou Women and Children's Hospital584 enrolled

Overview

The Supreme Laryngeal Mask Airway (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 elective Caesarean section. It has a double aperture design that facilitates the introduction of an orogastric tube to aspirate gastric contents. The primary study hypothesis is the first attempt insertion success rate of SLMA use in urgent Caesarean section.

Investigators propose a prospective cohort study to study the first attempt insertion success rate of supreme LMA in general anaesthesia for urgent caesarean section.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

584

Conditions

Airway Morbidity

Interventions

Supreme Laryngeal Mask AirwayDEVICE

Supreme Laryngeal Mask Airway. Preoxygenation, rapid sequence induction and cricoid pressure. Induction of general anaesthesia.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age 18 to 50 years old * American Society of Anesthesiology status 1 or 2 * Weight 40 to 75kg * Normal airway assessment * Term pregnancy (36 weeks or more) * Urgent Caesarean Section Exclusion Criteria: * Body mass index (35 or more) * Difficult airway (Mallampati 4 or abnormal airway assessment) * Gastrooesophageal reflux

Locations (1)

Quanzhou Women's and Children's Hospital

Quanzhou, Fujian, China

Outcomes

Primary Outcomes

First attempt insertion success rate

An attempt is defined as insertion and 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 waveform

Time frame: 1 hour

Aspiration

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

Time frame: 1 hour

blood on SLMA on removal

inspection for presence of blood upon removal of SLMA

Time frame: 1 hour

Sore throat

Sore throat present in recovery room

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 will be recorded.

Time frame: 1 hour

Gastric aspirate

Volume of gastric aspirate using gastric tube and pH of gastric aspirate using litmus paper

Data from ClinicalTrials.gov

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