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Completed

NCT Number: NCT02943980

Influenced the Type of Laryngoscopy the Intraoperative Nerve Monitoring During Thyroid Surgery

A randomized controlled prospective study of laryngoscopy and evaluation of the Intraoperative nerve monitoring during thyroid surgery comparing direct laryngoscopy and the C-MAC videolaryngoscope.

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Key information

Conditions

Thyroid Airway Morbidity Endocrine System Diseases Thyroid Diseases

Age range

18 year–100 year

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

Intraoperative nerve monitoring (IONM) is used in addition to the visual the nerve in thyroid surgery. Here, the IONM can be done by placing electrodes on an endotracheal tube. In order to guarantee a sufficient signal quality of the IONM, the electrode must be adequately positioned on the glottis. The present study pursued the question of whether the conventional direct laryngoscopy compared with video laryngoscopy allows a visually adequate tube placement.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age ≥ 18 Years No concurrent participation in another study
  • capacity to consent
  • Present written informed consent of the research participant
  • Elective surgery under general anesthesia

Exclusion criteria

  • Age <18 years
  • Existing pregnancy
  • Lack of consent
  • inability to consent
  • emergency patients
  • Emergency situations in the context of a Difficult Airway Management
  • ASA classification 4
  • situations where the possibility of accumulated gastric contents
  • Participation in another study

Treatment and study plan

CMAC Videolaryngoscope

Device

In a randomised order we evaluate the quality of the IONM after securing the airway with the CMAC

Macintosh laryngoscope

Device

In a randomised order we evaluate the quality of the IONM after securing the airway with the conventional Macintosh Laryngoscope

Primary outcomes

  1. Evaluation of the quality of the IONM during thyroid surgery

    Time frame: Quality IONM; intraoperative 1-3 hours

    Evaluation of intraoperative loss of the EMG-Signal (Quality character of the IONM)

Secondary outcomes

  1. intubation success

    Time frame: at intubation; < 120 Seconds

    successful tracheal intubation at the first attempt, compared to more than one attempt

  2. Cormack and Lehane Classification

    Time frame: during the laryngoscopy; < 120 Seconds

    airway visualization during intubation process

  3. Percentage of glottic opening

    Time frame: during the laryngoscopy; < 120 Seconds

    airway visualization during intubation process

  4. IDS (intubation difficult score)

    Time frame: < 120 Seconds

    Summation of specific characters during the tracheal intubation

Sponsors and collaborators

Lead sponsor

Johannes Gutenberg University Mainz

Other

Registry information

Official study title

Influenced the Type of Laryngoscopy the Intraoperative Nerve Monitoring During Thyroid Surgery; a Controlled, Randomized Study (LiON-Study)

Acronym: LiON

Important dates

Study start
2017
Primary completion
2018
Study completion
2019
First posted
Oct 25, 2016
Registry last updated
May 17, 2022

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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