ThyroidLiONNCT02943980
Influenced the Type of Laryngoscopy the Intraoperative Nerve Monitoring During Thyroid Surgery
A study testing CMAC Videolaryngoscope and Macintosh Laryngoscope in people with Thyroid and Airway Morbidity, run by Johannes Gutenberg University Mainz at 1 site in Germany.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Thyroid, Airway Morbidity
- What is being tested?
- CMAC Videolaryngoscope and Macintosh Laryngoscope
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 260 participants
- Where
- 1 siteGermany
- Study dates
- 3 Jan 2017to 15 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Age <18 years
- Existing pregnancy
- Lack of consent
- inability to consent
- emergency patients
- Emergency situations in the context of a Difficult Airway Management
Show all 9Show fewer
- ASA classification 4
- situations where the possibility of accumulated gastric contents
- Participation in another study
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Anesthesiology,Prof. C. Werner, Universitätsmedizin of the JG University
Mainz, Rhineland-Palatinate, D55131
About this study
Official title: Influenced the Type of Laryngoscopy the Intraoperative Nerve Monitoring During Thyroid Surgery; a Controlled, Randomized Study (LiON-Study)
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.
Read the detailed description
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.
- Conditions
- Thyroid, Airway Morbidity
- Being tested
- CMAC Videolaryngoscope, Macintosh Laryngoscope
- Keywords
- Intraoperative nerve monitoring, airway management
- Medical subject headings
- Thyroid Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CMAC VideolaryngoscopeDevice
In a randomised order we evaluate the quality of the IONM after securing the airway with the CMAC
Macintosh LaryngoscopeDevice
In a randomised order we evaluate the quality of the IONM after securing the airway with the conventional Macintosh Laryngoscope
| Study group | Role | What they receive |
|---|---|---|
| CMAC Videolaryngoscope | Experimental | tracheal intubation using CMAC Receives: Device: CMAC Videolaryngoscope |
| Macintosh laryngoscope | Experimental | tracheal intubation using Macintosh laryngoscope Receives: Device: Macintosh Laryngoscope |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the quality of the IONM during thyroid surgery
Evaluation of intraoperative loss of the EMG-Signal (Quality character of the IONM)
Measured: Quality IONM; intraoperative 1-3 hours
Secondary outcomes (4)
intubation success
successful tracheal intubation at the first attempt, compared to more than one attempt
Measured: at intubation; < 120 Seconds
Cormack and Lehane Classification
airway visualization during intubation process
Measured: during the laryngoscopy; < 120 Seconds
Percentage of glottic opening
airway visualization during intubation process
Measured: during the laryngoscopy; < 120 Seconds
IDS (intubation difficult score)
Summation of specific characters during the tracheal intubation
Measured: < 120 Seconds
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2016 (estimated)
- Study start3 Jan 2017
- Primary completionMay 2018
- Study completion15 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ThyroidStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 260 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johannes Gutenberg University Mainz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marc Kriege, MD, Johannes Gutenberg University Mainz
- Investigators
- Marc Kriege, MD, Principal investigator, University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02943980
- Sponsor's protocol ID
- JGU
- Acronym
- LiON
- Status last verified
- May 2022
- First submitted
- 13 Oct 2016
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influenced the Type of Laryngoscopy the Intraoperative Nerve Monitoring During Thyroid Surgery; a Controlled, Randomized Study (LiON-Study)
- ClinicalTrials.gov ID
- NCT02943980
- Acronym / sponsor ID
- LiON / JGU
- Conditions
- Thyroid, Airway Morbidity
- Keywords
- Intraoperative nerve monitoring, airway management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 260 participants (actual)
- Lead sponsor
- Johannes Gutenberg University MainzUniversity, hospital or other
- Study start
- 3 Jan 2017 (actual)
- Primary completion
- May 2018 (actual)
- Study completion
- 15 Feb 2019 (actual)
- First posted
- 25 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CMAC Videolaryngoscope | Experimental | Device: CMAC Videolaryngoscopetracheal intubation using CMAC |
| Macintosh laryngoscope | Experimental | Device: Macintosh Laryngoscopetracheal intubation using Macintosh laryngoscope |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (9 listed)
- Age <18 years
- Existing pregnancy
- Lack of consent
- inability to consent
- emergency patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CMAC VideolaryngoscopeIn a randomised order we evaluate the quality of the IONM after securing the airway with the CMAC | Device | CMAC Videolaryngoscope |
| Macintosh LaryngoscopeIn a randomised order we evaluate the quality of the IONM after securing the airway with the conventional Macintosh Laryngoscope | Device | Macintosh laryngoscope |
Primary outcome
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)
4 secondary outcomes
intubation success
Time frame: at intubation; < 120 Seconds
Cormack and Lehane Classification
Time frame: during the laryngoscopy; < 120 Seconds
Percentage of glottic opening
Time frame: during the laryngoscopy; < 120 Seconds
IDS (intubation difficult score)
Time frame: < 120 Seconds
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
- Individual participant dataSharing planned: No
Related trials for Thyroid
Recruiting
NIRAF-Guided Parathyroid Identification During Thyroidectomy
Hypocalcemia, Hypoparathyroidism
Active, not recruitingPhase 1
Prospective Exploratory Study of FAPi PET/CT With Histopathology Validation in Patients With Various Cancers
Bladder Carcinoma, Cervical Carcinoma
Not yet recruitingObservational study
Validation of Uzbek SARC-F and IPAQ-SF Questionnaires in Adults With and Without Hypothyroidism
Hypothyroidism, Psychometrics
Not yet recruitingPhase 1/2
177Lu-DOTA-EB-TATE in Adult Patients With Metastatic, Radioactive Iodine Non-Responsive Oncocytic (Hurthle-Cell) Thyroid Cancer
Thyroid Cancer
Recruiting
Safety and Efficacy of NTP in Thyroid Surgery: Pilot Study on Morbidity Prevention and Adjuvant Oncological Control
Thyroid Diseases, Wound Healing
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marc Kriege, MD principal investigator
University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CMAC Videolaryngoscope and Macintosh Laryngoscope in people with Thyroid and Airway Morbidity, run by Johannes Gutenberg University Mainz at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of the quality of the IONM during thyroid surgery (time frame: Quality IONM; intraoperative 1-3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2022.