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NCT03942809 Clinical Trial

Clinical Evaluation of the Revised iLTS-D2

Airway Management Clinical Trial

— iLTS-D2  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03942809
Other study ID # JohannesGU-iLT
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date August 13, 2019
Est. completion date April 15, 2020

Study information
Verified date April 2020
Source Johannes Gutenberg University Mainz
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date April 15, 2020
Est. primary completion date March 30, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- elective surgery patients under general Anesthesia

Exclusion Criteria:

- Age <18 years

- Existing pregnancy

- Lack of consent

- inability to consent

- emergency patients

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Effectiveness
Effectiveness and Practicability in anesthetized patient under controlled conditions

Locations
Country Name City State
Germany Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University Mainz Rhineland-Palatinate

Sponsors (1)
Lead Sponsor Collaborator
Johannes Gutenberg University Mainz

Country where clinical trial is conducted

Germany, 

Outcome
Type Measure Description Time frame Safety issue
Primary Insertion time LT Insertion of the laryngeal tube in 30 seconds
Secondary Insertion time ET Insertion of the endotracheal tube in 60 seconds
Secondary Rate of successful Intubation attempts successful insertion and tracheal intubation through study completion, an average of 120 seconds
Secondary hemodynamics MAP changes in MAP (mmHg) during cuff insufflation of laryngeal tube through study completion, an average of 360 seconds
Secondary hemodynamics Freq changes in heart frequency (bpm) through study completion, an average of 360 seconds
Secondary hemodynamics rO2 changes in cerebral oxygenation (percent) through study completion, an average of 360 seconds
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