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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03443219
Other study ID # 29/16
Secondary ID
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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