Vocal Cord Function in Neck Procedures
Conditions
Keywords
Thyroidectomy, Neck Procedures, Nerve Monitoring
Brief summary
The purpose of this study is to describe the impact of adding intraoperative video laryngoscopy (IOVL) to intraoperative laryngeal nerve monitoring (IOLNM) during neck procedures when IOLNM is routinely used, including thyroidectomy and re-operative parathyroidectomy. Specifically, the study team seeks to assess how frequently the use of IOVL provided confirmatory or additional information that may affect surgeon decision-making when IOLNM alone is ambiguous, or when there is equipment malfunction or failure. The IOVL is a disposable, otherwise standard fiberoptic laryngoscope (Larynxview, Neurovision Medical, Ventura CA) that is inserted alongside the endotracheal tube following intubation for surgical procedures. It allows assessment of vocal cord movement in response to nerve stimulation. Currently, the use of IOLNM is based on audio cues, and visual assessment of external laryngeal muscle movement during surgery in response to stimulation, but no direct assessment of vocal cord movement is routinely possible. This information can be ambiguous and subject to judgement of the surgeon. The addition of IOVL provides direct assessment to vocal cord movement in response to stimulus, and may be useful in light of ambiguous IOLNM data, or limited visualization of external laryngeal muscles.
Interventions
DEVICEIntraoperative Video Laryngoscopy
The IOVL is a disposable, otherwise standard fiberoptic laryngoscope that is inserted alongside the endotracheal tube following intubation for surgical procedures.
DRUGGlycopyrrolate
0.004mg/kg as per routine prior to intubation
Sponsors
NeuroVision
Icahn School of Medicine at Mount Sinai
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
All patients enrolled in the study will be in a single group.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 and older with capacity to make all medical decisions * Medical indication for partial or total thyroidectomy, re-operative parathyroidectomy, or neck dissection
Exclusion criteria
* Patients who are under the age of 18 * Patients who are not able to make medical decisions or consent to research
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Frequency of Congruence of Nerve Integrity and Vocal Cord Functions | up to 3 months post-resection | Frequency of congruence - IOVL used in conjunction with routine intraoperative nerve monitoring to provide additional data on nerve integrity and vocal cord functions for patients undergoing neck procedures that place the recurrent and superior laryngeal nerves at risk for injury or postoperative dysfunction. Video-captured vocal cord movement as well as the Nerveana Power Index (NPI) audio signal were recorded. Loss of signal was considered any NPI value \<100, which corresponds to loss of audio signal. The NPI is specific to the Nerveana machine, and is an index of the nerve/muscle response power (or area under the curve) as a percentage of the threshold level of response. Thus, positive EMG signal (EMG+) was an NPI value \>100. Positive IOVL (IOVL+) correlated with observed vocal cord movement on nerve stimulation; negative IOVL indicated no visible vocal cord movement. Discordances were considered to be contradictory IOVL and EMG (e.g., IOVL+ EMG-) findings for a particular nerve. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intraoperative Video Laryngoscopy Participants undergoing neck procedures
Intraoperative Video Laryngoscopy: The IOVL is a disposable, otherwise standard fiberoptic laryngoscope that is inserted alongside the endotracheal tube following intubation for surgical procedures.
Glycopyrrolate: 0.004mg/kg as per routine prior to intubation | 75 |
| Total | 75 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | no surgery or post-operative laryngoscopy | 50 |
Baseline characteristics
| Characteristic | Intraoperative Video Laryngoscopy |
|---|---|
| Age, Continuous | 52.1 years |
| BMI | 28.7 kg/m^2 |
| History of Thyroiditis | 13 Participants |
| Indication for surgery Cancer | 21 Participants |
| Indication for surgery Grave's Disease | 4 Participants |
| Indication for surgery Nontoxic Multinodular Goiter | 15 Participants |
| Indication for surgery Other | 18 Participants |
| Indication for surgery Suspicious Nodule | 14 Participants |
| Indication for surgery Toxic Multinodular Goiter | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 5 Participants |
| Race (NIH/OMB) Black or African American | 13 Participants |
| Race (NIH/OMB) More than one race | 19 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 18 Participants |
| Race (NIH/OMB) White | 20 Participants |
| Sex: Female, Male Female | 52 Participants |
| Sex: Female, Male Male | 23 Participants |
| Thyroid Size | 5.4 cm |
| Thyroid Weight | 28.0 grams |
| Type of surgery Left hemithyroidectomy | 18 Participants |
| Type of surgery Right hemithyroidectomy | 24 Participants |
| Type of surgery Total thyroidectomy | 33 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 75 |
| other Total, other adverse events | 2 / 75 |
| serious Total, serious adverse events | 1 / 75 |
Outcome results
Primary
Frequency of Congruence of Nerve Integrity and Vocal Cord Functions
Frequency of congruence - IOVL used in conjunction with routine intraoperative nerve monitoring to provide additional data on nerve integrity and vocal cord functions for patients undergoing neck procedures that place the recurrent and superior laryngeal nerves at risk for injury or postoperative dysfunction. Video-captured vocal cord movement as well as the Nerveana Power Index (NPI) audio signal were recorded. Loss of signal was considered any NPI value \<100, which corresponds to loss of audio signal. The NPI is specific to the Nerveana machine, and is an index of the nerve/muscle response power (or area under the curve) as a percentage of the threshold level of response. Thus, positive EMG signal (EMG+) was an NPI value \>100. Positive IOVL (IOVL+) correlated with observed vocal cord movement on nerve stimulation; negative IOVL indicated no visible vocal cord movement. Discordances were considered to be contradictory IOVL and EMG (e.g., IOVL+ EMG-) findings for a particular nerve.
Time frame: up to 3 months post-resection
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Intraoperative Video Laryngoscopy | Frequency of Congruence of Nerve Integrity and Vocal Cord Functions | EMG+ IOVL+ | 68 nerves at risk |
| Intraoperative Video Laryngoscopy | Frequency of Congruence of Nerve Integrity and Vocal Cord Functions | EMG+ IOVL- | 13 nerves at risk |
| Intraoperative Video Laryngoscopy | Frequency of Congruence of Nerve Integrity and Vocal Cord Functions | EMG- IOVL- | 17 nerves at risk |
| Intraoperative Video Laryngoscopy | Frequency of Congruence of Nerve Integrity and Vocal Cord Functions | EMG- IOVL+ | 10 nerves at risk |