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Completed

NCT Number: NCT03942809

Clinical Evaluation of the Revised iLTS-D2

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

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Key information

Conditions

Airway Management

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Mainz, Rhineland-Palatinate, D55131, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • elective surgery patients under general Anesthesia

Exclusion criteria

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

Treatment and study plan

Effectiveness

Device

Effectiveness and Practicability in anesthetized patient under controlled conditions

Primary outcomes

  1. Insertion time LT

    Time frame: in 30 seconds

    Insertion of the laryngeal tube

Secondary outcomes

  1. Insertion time ET

    Time frame: in 60 seconds

    Insertion of the endotracheal tube

  2. Rate of successful Intubation attempts

    Time frame: through study completion, an average of 120 seconds

    successful insertion and tracheal intubation

  3. hemodynamics MAP

    Time frame: through study completion, an average of 360 seconds

    changes in MAP (mmHg) during cuff insufflation of laryngeal tube

  4. hemodynamics Freq

    Time frame: through study completion, an average of 360 seconds

    changes in heart frequency (bpm)

  5. hemodynamics rO2

    Time frame: through study completion, an average of 360 seconds

    changes in cerebral oxygenation (percent)

Sponsors and collaborators

Lead sponsor

Johannes Gutenberg University Mainz

Other

Registry information

Official study title

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

Acronym: iLTS-D2

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 8, 2019
Registry last updated
Apr 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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