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

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ClinicalTrials.gov Identifier: NCT03443219
Recruitment Status : Completed
First Posted : February 23, 2018
Last Update Posted : February 23, 2018
Sponsor:
Information provided by (Responsible Party):
Silvia De Rosa, St. Bortolo Hospital

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.


Condition or disease Intervention/treatment Phase
Airway Management Device: Spritztube® Device: LMA Supreme™ Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 355 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Masking Description: opening a sealed envelope, provided by an independent physician blinded to patient's allocation In addition, outcome assessor were blinded
Primary Purpose: Health Services Research
Official Title: A Prospective Randomised Controlled Trial of the LMA Supreme™ Versus the Spritztube® Tracheal Cannula in Anesthetized Adult Patients
Actual Study Start Date : September 15, 2016
Actual Primary Completion Date : July 10, 2017
Actual Study Completion Date : October 20, 2017

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




Primary Outcome Measures :
  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 Outcome Measures :
  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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03443219


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

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Responsible Party: Silvia De Rosa, Medical Doctor, St. Bortolo Hospital
ClinicalTrials.gov Identifier: NCT03443219     History of Changes
Other Study ID Numbers: 29/16
First Posted: February 23, 2018    Key Record Dates
Last Update Posted: February 23, 2018
Last Verified: February 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Silvia De Rosa, St. Bortolo Hospital:
Airway Management
Extraglottic airway device
Laryngeal mask airway
Spritztube

Additional relevant MeSH terms:
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Chlorhexidine
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Infective Agents, Local
Anti-Infective Agents
Disinfectants