Supreme LMA Use in Urgent Caesarean Section

QuanZhou Women and Children's Hospital

Status: Completed

Conditions: Airway Morbidity

Treatments: Device: Supreme Laryngeal Mask Airway

Study type: Interventional

Funder types: Other

Identifiers

NCT02026882

2013-11-11

Details and patient eligibility

About

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.

Full description

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

Enrollment: 584 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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584 participants in 1 patient group

Supreme Laryngeal Mask Airway

Other group

Description:

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

Treatment:

Device: Supreme Laryngeal Mask Airway