RCT- LMA Supreme™ Versus the Spritztube® Tracheal Cannula in Anesthetized Adult Patients
- Conditions
- Airway Management
- Interventions
- Device: LMA Supreme™Device: Spritztube®
- Registration Number
- NCT03443219
- Lead Sponsor
- St. Bortolo Hospital
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 355
- American Society of Anaesthesiologists (ASA) physical status classification I, II, and III;
- Age > 18 years
- Elective surgery in the supine position
- Pregnancy
- Age <18 years
- Not eligibility for surgery
- Predicted difficult airway management
- Positive history for esophageal or pharyngeal diseases
- Emergency surgery
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description LMA Supreme™ LMA Supreme™ 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. Spritztube® Spritztube® 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.
- Primary Outcome Measures
Name Time Method the successful placement of device in two groups Intraoperative 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.
- Secondary Outcome Measures
Name Time Method Insertion time (in seconds) Intraoperative The insertion time was measured from the insertion of device into the patient's mouth to connecting the breathing circuit.
Easy to insert Intraoperative A successful insertion of device in just one attempt
number of complications at insertion Intraoperative air leak at induction, laryngospasm, obstruction after induction, gastric insufflation, failure device
Number of attempts Intraoperative If placement had failed after three attempts, the study was abandoned and the airway was maintained through a tracheal tube.
number of complications at removal Postoperative dysphagia, hoarseness and sore throat