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

Sponsor
St. Bortolo Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT03443219
Collaborator
(none)
355
Enrollment
2
Arms
13.1
Actual Duration (Months)

Study Details

Study Description

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
  • Device: Spritztube®
  • Device: LMA Supreme™
 N/A

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 Design

Study Type:
Interventional
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 :
Sep 15, 2016
Actual Primary Completion Date :
Jul 10, 2017
Actual Study Completion Date :
Oct 20, 2017

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. the successful placement of device in two groups [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) [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 [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 [Intraoperative]

    A successful insertion of device in just one attempt

  4. number of complications at insertion [Intraoperative]

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

  5. number of complications at removal [Postoperative]

    dysphagia, hoarseness and sore throat

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

  • St. Bortolo Hospital

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Silvia De Rosa, Medical Doctor, St. Bortolo Hospital
ClinicalTrials.gov Identifier:
NCT03443219
Other Study ID Numbers:
  • 29/16
First Posted:
Feb 23, 2018
Last Update Posted:
Feb 23, 2018
Last Verified:
Feb 1, 2018
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Silvia De Rosa, Medical Doctor, St. Bortolo Hospital
Airway Management
Extraglottic airway device
Laryngeal mask airway
Spritztube

Study Results

No Results Posted as of Feb 23, 2018