NCT03942809

Brief Summary

A interventional, non-randomized, controlled study to evaluate the revised iLTS-D2 in anesthetized patients.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Aug 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

April 22, 2019

Completed
16 days until next milestone

First Posted

Study publicly available on registry

May 8, 2019

Completed
3 months until next milestone

Study Start

First participant enrolled

August 13, 2019

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 30, 2020

Completed
16 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 15, 2020

Completed
Last Updated

April 28, 2020

Status Verified

April 1, 2020

Enrollment Period

8 months

First QC Date

April 22, 2019

Last Update Submit

April 26, 2020

Conditions

Airway Management

Keywords

Airway Morbidity

Outcome Measures

Primary Outcomes (1)

  • Insertion time LT

    Insertion of the laryngeal tube

    in 30 seconds

Secondary Outcomes (5)

  • Insertion time ET

    in 60 seconds

  • Rate of successful Intubation attempts

    through study completion, an average of 120 seconds

  • hemodynamics MAP

    through study completion, an average of 360 seconds

  • hemodynamics Freq

    through study completion, an average of 360 seconds

  • hemodynamics rO2

    through study completion, an average of 360 seconds

Study Arms (1)

Effectiveness

EXPERIMENTAL

Evaluate the Effectiveness in insertion success, insertion times, influence of respiratory, cardiac and cerebral circulation

Device: Effectiveness

Interventions

EffectivenessDEVICE

Effectiveness and Practicability in anesthetized patient under controlled conditions

Effectiveness

Eligibility Criteria

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

You may qualify if:

  • elective surgery patients under general Anesthesia

You may not qualify if:

  • Age \<18 years
  • Existing pregnancy
  • Lack of consent
  • inability to consent
  • emergency patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University

Mainz, Rhineland-Palatinate, D55131, Germany

Location

Study Officials

  • Marc Kriege, MD

    University Medical Center Mainz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

April 22, 2019

First Posted

May 8, 2019

Study Start

August 13, 2019

Primary Completion

March 30, 2020

Study Completion

April 15, 2020

Last Updated

April 28, 2020

Record last verified: 2020-04

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)