Airway Morbidity
Conditions
Keywords
Airway, Caesarean
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.
Interventions
Supreme Laryngeal Mask Airway. Preoxygenation, rapid sequence induction and cricoid pressure. Induction of general anaesthesia.
Sponsors
KK Women's and Children's Hospital
QuanZhou Women and Children's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| First attempt insertion success rate | 1 hour | An attempt is defined as insertion and withdrawal of the device from the patient's airway |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| Regurgitation | 1 hour | Gastric contents identified in the mouth with pH less than 4 |
Countries
China
Outcome results
None listed