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

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

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.

Study Overview

• Status: Completed
• Conditions: Airway Management
• Intervention / Treatment: Device: Spritztube®; Device: LMA Supreme™

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.

• Study Type: Interventional
• Enrollment (Actual): 355
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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.	Device: Spritztube®; After preoxygenation, anaesthesia was induced with midazolam, propofol, and fentanyl,Spritztube® was inserted and both cuffs inflated
ACTIVE_COMPARATOR: 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.	Device: LMA Supreme™; After preoxygenation, anaesthesia was induced with midazolam, propofol, and fentanyl,LMA Supreme™ was inserted and both cuffs inflated

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: St. Bortolo Hospital
• Investigators: Study Director: Raffaele Bonato, MD, Department of Anesthesiology and Intensive Care, San Bortolo Hospital, Vicenza, Italy

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 15, 2016
• Primary Completion (ACTUAL): July 10, 2017
• Study Completion (ACTUAL): October 20, 2017

Study Registration Dates

• First Submitted: February 12, 2018
• First Submitted That Met QC Criteria: February 22, 2018
• First Posted (ACTUAL): February 23, 2018

Study Record Updates

• Last Update Posted (ACTUAL): February 23, 2018
• Last Update Submitted That Met QC Criteria: February 22, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Keywords: Airway Management; Laryngeal mask airway; Extraglottic airway device; Spritztube
• Other Study ID Numbers: 29/16

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No