Supreme LMA and Endotracheal Intubation Use in Caesarean Section

Study Overview
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Brief Summary
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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
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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.

Official Title
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Supreme LMA Versus Endotracheal Intubation in General Anaesthesia for Elective Caesarean Section- a Randomised Controlled Trial

Conditions
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Complications; Cesarean Section

Intervention / Treatment
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* Device: Endotracheal intubation
* 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 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

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supreme Laryngeal Mask Airway<br>Supreme Laryngeal Mask Airway (Airway Device) with gastric tube. Preoxygenation, rapid sequence induction and cricoid pressure. Propofol 2 to 3mg/kg with 100mg succinylcholine. General anaesthesia with sevoflurane. | Device: Supreme Laryngeal Mask Airway<br>* Supreme Laryngeal Mask Airway Size 3 or Size 4 with gastric tube insertion.<br>|
| Active Comparator: Endotracheal Intubation<br>Endotracheal intubation (Airway Device) using Macintosh Laryngoscope with tracheal tube with gastric tube insertion after placement. Preoxygenation, rapid sequence induction and cricoid pressure. Propofol 2 to 3mg/kg with 100mg succinylcholine. General anaesthesia with sevoflurane. | Device: Endotracheal intubation<br>* Portex endotracheal tube 6.5mm or 7.0mm internal diameter<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 complete 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 wave form | 1 hour | 
| Aspiration | 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 | 1 hour | 
| blood on SLMA on removal | inspection for presence of blood on Supreme Laryngeal Mask Airway on removal | 1 hour | 
| Sore Throat | Sore throat present in the postanaesthesia care unit | 1 hour | 
| Patient satisfaction | Patient satisfaction with whole anaesthetic experience at 24 hours postsurgery (0 to 100%) | 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 was recorded. | 1 hour | 
| Gastric aspirate | Volume of gastric aspiration 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, Cesarean