RCT- LMA Supreme™ Versus the Spritztube® Tracheal Cannula in Anesthetized Adult Patients

Study Overview
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Brief Summary
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The study compares the LMA Supreme™ versus the Spritztube® tracheal cannula in anesthetized adult patients. The current randomized study is designed to assess the success placement of blind insertion using LMA Supreme™ , in comparison with the Spritztube® tracheal cannula. In addition, time, number of attempts, easy insertion and the number of complications at insertion and removal will be assessed. The investigators hypothesize that the LMA Supreme™ versus the Spritztube® tracheal cannula will similarly perform during anesthetized adult patients despite differences in their structural design.

Detailed Description
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A new extraglottic airway device, the Spritztube® [tracheal cannula, Med Europe s.r.l], was developed combining the ability to perform both EAD ventilation and oro-tracheal fibreoptic intubation using the same device. The Spritztube® consists of a silicone cannula with two low-pressure cuffs: a proximal cuff, designed to seal the pharynx cranially of the epiglottis and a distal cuff, designed to seal the oesophagus. The positioning of this device requires the aid of a spindle, that keep the cuffs on the same line and it is rigid enough to allow the passage through oropharynx tissue. That can be inserted blindly as extraglottic device or through the use of direct laryngoscopy or fibroscopy as tracheal cannula. The current randomized study is designed to assess the success placement of blind insertion using LMA Supreme™ , in comparison with the Spritztube® tracheal cannula. In addition, time, number of attempts, easy insertion and the number of complications at insertion and removal will be assessed.

Official Title
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A Prospective Randomised Controlled Trial of the LMA Supreme™ Versus the Spritztube® Tracheal Cannula in Anesthetized Adult Patients

Conditions
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Airway Management

Intervention / Treatment
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* Device: Spritztube®
* Device: LMA Supreme™


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: American Society of Anaesthesiologists (ASA) physical status classification I, II, and III; Age > 18 years Elective surgery in the supine position Exclusion Criteria: Pregnancy Age <18 years Not eligibility for surgery Predicted difficult airway management Positive history for esophageal or pharyngeal diseases Emergency surgery

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Spritztube®<br>The patients were randomly allocated to two groups by using computer-generated numbers.In Spritztube® group, Spritztube® was inserted into each patient after anesthesia induction. | Device: Spritztube®<br>* After preoxygenation, anaesthesia was induced with midazolam, propofol, and fentanyl,Spritztube® was inserted and both cuffs inflated<br>|
| Active Comparator: LMA Supreme™<br>The patients were randomly allocated to two groups by using computer-generated numbers.In vgroup, LMA Supreme™was inserted into each patient after anesthesia induction. | Device: LMA Supreme™<br>* After preoxygenation, anaesthesia was induced with midazolam, propofol, and fentanyl,LMA Supreme™ was inserted and both cuffs inflated<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the successful placement of device in two groups | A successful intubation attempt was recognized if the breathing circuit was connected, the breath sounds over the lung were present and the End tidal CO2 trace was revealed. | Intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insertion time (in seconds) | The insertion time was measured from the insertion of device into the patient's mouth to connecting the breathing circuit. | Intraoperative | 
| Number of attempts | If placement had failed after three attempts, the study was abandoned and the airway was maintained through a tracheal tube. | Intraoperative | 
| Easy to insert | A successful insertion of device in just one attempt | Intraoperative | 
| number of complications at insertion | air leak at induction, laryngospasm, obstruction after induction, gastric insufflation, failure device | Intraoperative | 
| number of complications at removal | dysphagia, hoarseness and sore throat | Postoperative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Airway Management, Extraglottic airway device, Laryngeal mask airway, Spritztube