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Completed

NCT Number: NCT03443219

RCT- 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.

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Key information

Conditions

Airway Management

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spritztube®

Device

After preoxygenation, anaesthesia was induced with midazolam, propofol, and fentanyl,Spritztube® was inserted and both cuffs inflated

LMA Supreme™

Device

After preoxygenation, anaesthesia was induced with midazolam, propofol, and fentanyl,LMA Supreme™ was inserted and both cuffs inflated

Primary outcomes

  1. the successful placement of device in two groups

    Time frame: Intraoperative

    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.

Secondary outcomes

  1. Insertion time (in seconds)

    Time frame: Intraoperative

    The insertion time was measured from the insertion of device into the patient's mouth to connecting the breathing circuit.

  2. Number of attempts

    Time frame: Intraoperative

    If placement had failed after three attempts, the study was abandoned and the airway was maintained through a tracheal tube.

  3. Easy to insert

    Time frame: Intraoperative

    A successful insertion of device in just one attempt

  4. number of complications at insertion

    Time frame: Intraoperative

    air leak at induction, laryngospasm, obstruction after induction, gastric insufflation, failure device

  5. number of complications at removal

    Time frame: Postoperative

    dysphagia, hoarseness and sore throat

Sponsors and collaborators

Lead sponsor

St. Bortolo Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Feb 23, 2018
Registry last updated
Feb 23, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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