Clinical Evaluation of the Revised iLTS-D2 (iLTS-D2)

Clinical Evaluation of the Revised iLTS-D2 in Effectivity and Practicability

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

Study Overview

• Status: Completed
• Conditions: Airway Management
• Intervention / Treatment: Device: Effectiveness

Detailed Description

The revised Intubation laryngeal tube - disposable (iLTS-D) is a refined laryngeal tube, which allows a secondary intubation over the inserted laryngeal tube. The present study should reveal the effectiveness and practicability in anesthetized patients in the operation room.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Germany
  • Rhineland-Palatinate
    • Mainz, Rhineland-Palatinate, Germany, D55131
      • Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• elective surgery patients under general Anesthesia

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Effectiveness; Evaluate the Effectiveness in insertion success, insertion times, influence of respiratory, cardiac and cerebral circulation	Device: Effectiveness; Effectiveness and Practicability in anesthetized patient under controlled conditions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insertion time LT	Insertion of the laryngeal tube	in 30 seconds

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Insertion time ET	Insertion of the endotracheal tube	in 60 seconds
Rate of successful Intubation attempts	successful insertion and tracheal intubation	through study completion, an average of 120 seconds
hemodynamics MAP	changes in MAP (mmHg) during cuff insufflation of laryngeal tube	through study completion, an average of 360 seconds
hemodynamics Freq	changes in heart frequency (bpm)	through study completion, an average of 360 seconds
hemodynamics rO2	changes in cerebral oxygenation (percent)	through study completion, an average of 360 seconds

Collaborators and Investigators

• Sponsor: Johannes Gutenberg University Mainz

Study record dates

Study Major Dates

• Study Start (Actual): August 13, 2019
• Primary Completion (Actual): March 30, 2020
• Study Completion (Actual): April 15, 2020

Study Registration Dates

• First Submitted: April 22, 2019
• First Submitted That Met QC Criteria: May 7, 2019
• First Posted (Actual): May 8, 2019

Study Record Updates

• Last Update Posted (Actual): April 28, 2020
• Last Update Submitted That Met QC Criteria: April 26, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: Airway Morbidity
• Other Study ID Numbers: JohannesGU-iLT

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No