Complications; Cesarean Section
Conditions
Keywords
Airway, Cesarean
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.
Interventions
DEVICEEndotracheal intubation
Portex endotracheal tube 6.5mm or 7.0mm internal diameter
Supreme Laryngeal Mask Airway Size 3 or Size 4 with gastric tube insertion.
Sponsors
KK Women's and Children's Hospital
Wei Yu Yao
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 50 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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%) |
| 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 |
| 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. |
| Gastric aspirate | 1 hour | Volume of gastric aspiration 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 |
Outcome results
None listed