Supreme LMA and Endotracheal Intubation Use in Caesarean Section

Not Applicable

Completed

• Conditions: Complications; Cesarean Section
• Interventions: Device: Endotracheal intubation; Device: Supreme Laryngeal Mask Airway

• Registration Number: NCT01858467
• Lead Sponsor: Wei Yu Yao

Brief Summary

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%.

Detailed 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.

Study Timeline

• Study First Submitted: 2013-04-07
• Study Start: 2013-05
• Study First Submitted QC: 2013-05-16
• Study First Posted: 2013-05-21
• Primary Completion: 2014-07
• Study Completion: 2014-07
• Status Verified: 2018-05
• Last Update Submitted: 2018-05-04
• Last Update Posted: 2018-05-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 920

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Endotracheal Intubation	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.
Supreme Laryngeal Mask Airway	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.

Primary Outcome Measures

Name	Time	Method
First attempt insertion success rate	1 hour	An attempt is defined as insertion and complete withdrawal of the device from the patient's airway

Secondary Outcome Measures

Name	Time	Method
Time to effective airway placement	1 hour	Interval from when the device was picked up until appearance of the first end-tidal carbon dioxide wave form
Gastric aspirate	1 hour	Volume of gastric aspiration using gastric tube and pH of gastric aspirate using litmus paper
Regurgitation	1 hour	Gastric contents identified in the mouth with pH less than 4
Seal pressure	1 hour	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.
Aspiration	1 hour	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
blood on SLMA on removal	1 hour	inspection for presence of blood on Supreme Laryngeal Mask Airway on removal
Neonatal outcomes	1 hour	Neonatal birthweight. APGAR score. Umbilical venous cord pH.
Sore Throat	1 hour	Sore throat present in the postanaesthesia care unit
Patient satisfaction	1 hour	Patient satisfaction with whole anaesthetic experience at 24 hours postsurgery (0 to 100%)