Clinical trial NCT03443219: RCT- LMA Supreme™ Versus the Spritztube® Tracheal Cannula in Anesthetized Adult Patients
Official title: A Prospective Randomised Controlled Trial of the LMA Supreme™ Versus the Spritztube® Tracheal Cannula in Anesthetized Adult Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Airway Management
Keywords: Airway Management
Extraglottic airway device
Laryngeal mask airway
Spritztube
Lead sponsor: St. Bortolo Hospital
Sponsor class: OTHER
First posted: 2018-02-23
Enrollment: 355
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

Eligibility criteria: 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

Primary outcomes:
measure: the successful placement of device in two groups
timeFrame: Intraoperative
Secondary outcomes:
measure: Insertion time (in seconds)
timeFrame: Intraoperative
measure: Number of attempts
timeFrame: Intraoperative
measure: Easy to insert
timeFrame: Intraoperative
measure: number of complications at insertion
timeFrame: Intraoperative
measure: number of complications at removal
timeFrame: Postoperative
Other outcomes:
Locations:
Study officials:
affiliation: Department of Anesthesiology and Intensive Care, San Bortolo Hospital, Vicenza, Italy
name: Raffaele Bonato, MD
role: STUDY_DIRECTOR
References:
citation: De Rosa S, Messina A, Sorbello M, Rigobello A, Colombo D, Piccolo A, Bonaldi E, Gennaro P, Urukalo V, Pellizzari A, Bonato R, Carboni SC. Laryngeal Mask Airway Supreme vs. the Spritztube tracheal cannula in anaesthetised adult patients: A randomised controlled trial. Eur J Anaesthesiol. 2019 Dec;36(12):955-962. doi: 10.1097/EJA.0000000000001106.