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

Airway Management Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03443219
• Other study ID #: 29/16
• Status: Completed
• Phase: N/A
• First received: February 12, 2018
• Last updated: February 22, 2018
• Start date: September 15, 2016
• Est. completion date: October 20, 2017

Study information

• Verified date: February 2018
• Source: St. Bortolo Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 355
• Est. completion date: October 20, 2017
• Est. primary completion date: July 10, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Airway Management

Intervention

Device:
• Spritztube®
After preoxygenation, anaesthesia was induced with midazolam, propofol, and fentanyl,Spritztube® was inserted and both cuffs inflated
• LMA Supreme™
After preoxygenation, anaesthesia was induced with midazolam, propofol, and fentanyl,LMA Supreme™ was inserted and both cuffs inflated

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
St. Bortolo Hospital

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Number of attempts	If placement had failed after three attempts, the study was abandoned and the airway was maintained through a tracheal tube.	Intraoperative
Secondary	Easy to insert	A successful insertion of device in just one attempt	Intraoperative
Secondary	number of complications at insertion	air leak at induction, laryngospasm, obstruction after induction, gastric insufflation, failure device	Intraoperative
Secondary	number of complications at removal	dysphagia, hoarseness and sore throat	Postoperative