An interventional study of Spritztube® and LMA Supreme™ in Airway Management, sponsored by St. Bortolo Hospital. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2018-02-23.
Sponsored by St. Bortolo Hospital · Not applicable, Interventional, and Health services research
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.
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.
St. Bortolo Hospital is the lead sponsor of 7 studies on the registry; none are open to participants now.
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Exclusion Criteria:
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®
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™
After preoxygenation, anaesthesia was induced with midazolam, propofol, and fentanyl,Spritztube® was inserted and both cuffs inflated
After preoxygenation, anaesthesia was induced with midazolam, propofol, and fentanyl,LMA Supreme™ was inserted and both cuffs inflated
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.
Time frame: Intraoperative
Insertion time (in seconds)
The insertion time was measured from the insertion of device into the patient's mouth to connecting the breathing circuit.
Time frame: Intraoperative
Number of attempts
If placement had failed after three attempts, the study was abandoned and the airway was maintained through a tracheal tube.
Time frame: Intraoperative
Easy to insert
A successful insertion of device in just one attempt
Time frame: Intraoperative
number of complications at insertion
air leak at induction, laryngospasm, obstruction after induction, gastric insufflation, failure device
Time frame: Intraoperative
number of complications at removal
dysphagia, hoarseness and sore throat
Time frame: Postoperative
No study locations are listed for this record.
Ran from Sep 2016 to primary completion in Jul 2017, 9 months.
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This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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St. Bortolo Hospital