Supreme LMA Use in Urgent Caesarean Section

Supreme Laryngeal Mask Use in Urgent Caesarean Section

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.

Study Overview

• Status: Completed
• Conditions: Airway Morbidity
• Intervention / Treatment: Device: Supreme Laryngeal Mask Airway

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 584
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Fujian
    • Quanzhou, Fujian, China, 700
      • Quanzhou Women's and Children's Hospital

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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Supreme Laryngeal Mask Airway; Supreme Laryngeal Mask Airway with gastric tube. Preoxygenation, rapid sequence induction and cricoid pressure. Induction of general anaesthesia.	Device: Supreme Laryngeal Mask Airway; Supreme Laryngeal Mask Airway. Preoxygenation, rapid sequence induction and cricoid pressure. Induction of general anaesthesia.

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 withdrawal of the device from the patient's airway	1 hour

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to effective airway placement	Interval from when the device was picked up until appearance of the first end-tidal carbon dioxide waveform	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	1 hour
blood on SLMA on removal	inspection for presence of blood upon removal of SLMA	1 hour
Sore throat	Sore throat present in recovery room	1 hour
Regurgitation	Gastric contents identified in the mouth with pH less than 4	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.	1 hour
Gastric aspirate	Volume of gastric aspirate 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: QuanZhou Women and Children's Hospital
• Collaborators: KK Women's and Children's Hospital

Publications and helpful links

General Publications

• Lim MJ, Tan HS, Tan CW, Li SY, Yao WY, Yuan YJ, Sultana R, Sng BL. The effects of labor on airway outcomes with Supreme laryngeal mask in women undergoing cesarean delivery under general anesthesia: a cohort study. BMC Anesthesiol. 2020 Aug 26;20(1):213. doi: 10.1186/s12871-020-01132-5.
• Tan HS, Li SY, Yao WY, Yuan YJ, Sultana R, Han NR, Sia ATH, Sng BL. Association of Mallampati scoring on airway outcomes in women undergoing general anesthesia with Supreme laryngeal mask airway in cesarean section. BMC Anesthesiol. 2019 Jul 8;19(1):122. doi: 10.1186/s12871-019-0796-5.
• Li SY, Yao WY, Yuan YJ, Tay WS, Han NR, Sultana R, Assam PN, Sia AT, Sng BL. Supreme laryngeal mask airway use in general Anesthesia for category 2 and 3 Cesarean delivery: a prospective cohort study. BMC Anesthesiol. 2017 Dec 19;17(1):169. doi: 10.1186/s12871-017-0460-x.

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): May 1, 2015

Study Registration Dates

• First Submitted: December 31, 2013
• First Submitted That Met QC Criteria: December 31, 2013
• First Posted (Estimate): January 3, 2014

Study Record Updates

• Last Update Posted (Actual): August 3, 2020
• Last Update Submitted That Met QC Criteria: July 31, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Airway, Caesarean
• Other Study ID Numbers: 2013-11-11