Supreme LMA Use in Urgent Caesarean Section

Study Overview
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Brief Summary
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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
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Investigators propose a prospective cohort study to study the first attempt insertion success rate of supreme LMA in general anaesthesia for urgent caesarean section.

Official Title
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Supreme Laryngeal Mask Use in Urgent Caesarean Section

Conditions
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Airway Morbidity

Intervention / Treatment
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* Device: Supreme Laryngeal Mask Airway


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Airway, Caesarean