NCT03443219

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
355

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 15, 2016

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 10, 2017

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 20, 2017

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 12, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

February 23, 2018

Completed
Last Updated

February 23, 2018

Status Verified

February 1, 2018

Enrollment Period

10 months

First QC Date

February 12, 2018

Last Update Submit

February 22, 2018

Conditions

Airway Management

Keywords

Airway ManagementExtraglottic airway deviceLaryngeal mask airwaySpritztube

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (5)

  • Insertion time (in seconds)

    Intraoperative

  • Number of attempts

    Intraoperative

  • Easy to insert

    Intraoperative

  • number of complications at insertion

    Intraoperative

  • number of complications at removal

    Postoperative

Study Arms (2)

Spritztube®

EXPERIMENTAL

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®

LMA Supreme™

ACTIVE COMPARATOR

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™

Interventions

Spritztube®DEVICE

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

Spritztube®
LMA Supreme™DEVICE

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

LMA Supreme™

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American Society of Anaesthesiologists (ASA) physical status classification I, II, and III;
  • Age \> 18 years
  • Elective surgery in the supine position

You may not qualify if:

  • Pregnancy
  • Age \<18 years
  • Not eligibility for surgery
  • Predicted difficult airway management
  • Positive history for esophageal or pharyngeal diseases
  • Emergency surgery

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • De Rosa S, Messina A, Sorbello M, Rigobello A, Colombo D, Piccolo A, Bonaldi E, Gennaro P, Urukalo V, Pellizzari A, Bonato R, Carboni SC. Laryngeal Mask Airway Supreme vs. the Spritztube tracheal cannula in anaesthetised adult patients: A randomised controlled trial. Eur J Anaesthesiol. 2019 Dec;36(12):955-962. doi: 10.1097/EJA.0000000000001106.

    PMID: 31644512DERIVED

Study Officials

  • Raffaele Bonato, MD

    Department of Anesthesiology and Intensive Care, San Bortolo Hospital, Vicenza, Italy

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
opening a sealed envelope, provided by an independent physician blinded to patient's allocation In addition, outcome assessor were blinded
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Medical Doctor

Study Record Dates

First Submitted

February 12, 2018

First Posted

February 23, 2018

Study Start

September 15, 2016

Primary Completion

July 10, 2017

Study Completion

October 20, 2017

Last Updated

February 23, 2018

Record last verified: 2018-02