Influenced the Type of Laryngoscopy the Intraoperative Nerve Monitoring During Thyroid Surgery
LiON
1 other identifier
interventional
260
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jan 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 13, 2016
CompletedFirst Posted
Study publicly available on registry
October 25, 2016
CompletedStudy Start
First participant enrolled
January 3, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
February 15, 2019
CompletedMay 17, 2022
May 1, 2022
1.3 years
October 13, 2016
May 14, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Evaluation of the quality of the IONM during thyroid surgery
Evaluation of intraoperative loss of the EMG-Signal (Quality character of the IONM)
Quality IONM; intraoperative 1-3 hours
Secondary Outcomes (4)
intubation success
at intubation; < 120 Seconds
Cormack and Lehane Classification
during the laryngoscopy; < 120 Seconds
Percentage of glottic opening
during the laryngoscopy; < 120 Seconds
IDS (intubation difficult score)
< 120 Seconds
Study Arms (2)
CMAC Videolaryngoscope
EXPERIMENTALtracheal intubation using CMAC
Macintosh laryngoscope
EXPERIMENTALtracheal intubation using Macintosh laryngoscope
Interventions
In a randomised order we evaluate the quality of the IONM after securing the airway with the CMAC
In a randomised order we evaluate the quality of the IONM after securing the airway with the conventional Macintosh Laryngoscope
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
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
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marc Kriege, MD
University Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- MD
Study Record Dates
First Submitted
October 13, 2016
First Posted
October 25, 2016
Study Start
January 3, 2017
Primary Completion
May 1, 2018
Study Completion
February 15, 2019
Last Updated
May 17, 2022
Record last verified: 2022-05
Data Sharing
- IPD Sharing
- Will not share