Supreme LMA and Endotracheal Intubation Use in Caesarean Section

Supreme LMA Versus Endotracheal Intubation in General Anaesthesia for Elective Caesarean Section- a Randomised Controlled Trial

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%.

Study Overview

• Status: Completed
• Conditions: Complications; Cesarean Section
• Intervention / Treatment: Device: Supreme Laryngeal Mask Airway; Device: Endotracheal intubation

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 Type: Interventional
• Enrollment (Actual): 920
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Device: Supreme Laryngeal Mask Airway; Supreme Laryngeal Mask Airway Size 3 or Size 4 with gastric tube insertion.
Active Comparator: 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.	Device: Endotracheal intubation; Portex endotracheal tube 6.5mm or 7.0mm internal diameter

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
First attempt insertion success rate	An attempt is defined as insertion and complete withdrawal of the device from the patient's airway	1 hour

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Wei Yu Yao
• Collaborators: KK Women's and Children's Hospital
• Investigators: Study Director: Shi Y Li, MD, Quanzhou Women's and Children's Hospital

Publications and helpful links

General Publications

• Yao WY, Li SY, Yuan YJ, Tan HS, Han NR, Sultana R, Assam PN, Sia AT, Sng BL. Comparison of Supreme laryngeal mask airway versus endotracheal intubation for airway management during general anesthesia for cesarean section: a randomized controlled trial. BMC Anesthesiol. 2019 Jul 8;19(1):123. doi: 10.1186/s12871-019-0792-9.

Study record dates

Study Major Dates

• Study Start (Actual): May 1, 2013
• Primary Completion (Actual): July 1, 2014
• Study Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: April 7, 2013
• First Submitted That Met QC Criteria: May 16, 2013
• First Posted (Estimate): May 21, 2013

Study Record Updates

• Last Update Posted (Actual): May 7, 2018
• Last Update Submitted That Met QC Criteria: May 4, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Airway, Cesarean
• Other Study ID Numbers: 2012-10-27