Supreme LMA Use in Urgent Caesarean Section
- Conditions
- Airway Morbidity
- Registration Number
- NCT02026882
- Lead Sponsor
- QuanZhou Women and Children's Hospital
- Brief Summary
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.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 584
- 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
- Body mass index (35 or more)
- Difficult airway (Mallampati 4 or abnormal airway assessment)
- Gastrooesophageal reflux
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method First attempt insertion success rate 1 hour An attempt is defined as insertion and withdrawal of the device from the patient's airway
- Secondary Outcome Measures
Name Time Method Aspiration 1 hour 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 to effective airway placement 1 hour Interval from when the device was picked up until appearance of the first end-tidal carbon dioxide waveform
Regurgitation 1 hour Gastric contents identified in the mouth with pH less than 4
blood on SLMA on removal 1 hour inspection for presence of blood upon removal of SLMA
Sore throat 1 hour Sore throat present in recovery room
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 will be recorded.
Gastric aspirate 1 hour Volume of gastric aspirate using gastric tube and pH of gastric aspirate using litmus paper
Neonatal outcomes 1 hour Neonatal birthweight. APGAR score. Umbilical venous cord pH
Trial Locations
- Locations (1)
Quanzhou Women's and Children's Hospital
🇨🇳Quanzhou, Fujian, China
Quanzhou Women's and Children's Hospital🇨🇳Quanzhou, Fujian, China