Trial Outcomes & Findings for Intraoperative Video Laryngoscopy as Adjunct for Nerve Monitoring (NCT NCT03742141)

NCT ID: NCT03742141

Last Updated: 2023-10-02

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 125 participants
• Primary outcome timeframe: up to 3 months post-resection
• Results posted on: 2023-10-02

Participant Flow

Participant milestones

Measure	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
Overall Study STARTED	125
Overall Study COMPLETED	75
Overall Study NOT COMPLETED	50

Reasons for withdrawal

Measure	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
Overall Study no surgery or post-operative laryngoscopy	50

Baseline Characteristics

Intraoperative Video Laryngoscopy as Adjunct for Nerve Monitoring

Baseline characteristics by cohort

Measure	Intraoperative Video Laryngoscopy n=75 Participants 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
Age, Continuous	52.1 years n=5 Participants
Sex: Female, Male Female	52 Participants n=5 Participants
Sex: Female, Male Male	23 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	5 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	13 Participants n=5 Participants
Race (NIH/OMB) White	20 Participants n=5 Participants
Race (NIH/OMB) More than one race	19 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	18 Participants n=5 Participants
BMI	28.7 kg/m^2 n=5 Participants
History of Thyroiditis	13 Participants n=5 Participants
Thyroid Weight	28.0 grams n=5 Participants
Thyroid Size	5.4 cm n=5 Participants
Indication for surgery Cancer	21 Participants n=5 Participants
Indication for surgery Nontoxic Multinodular Goiter	15 Participants n=5 Participants
Indication for surgery Toxic Multinodular Goiter	3 Participants n=5 Participants
Indication for surgery Suspicious Nodule	14 Participants n=5 Participants
Indication for surgery Grave's Disease	4 Participants n=5 Participants
Indication for surgery Other	18 Participants n=5 Participants
Type of surgery Right hemithyroidectomy	24 Participants n=5 Participants
Type of surgery Left hemithyroidectomy	18 Participants n=5 Participants
Type of surgery Total thyroidectomy	33 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Intraoperative Video Laryngoscopy n=108 nerves at risk 75 participants (108 nerves at risk) undergoing thyroid lobectomy or total thyroidectomy for benign and malignant disease with concurrent use of intraoperative video laryngeal monitoring and intermittent standard EMG monitoring, using the Nerveana nerve monitoring system.
Frequency of Congruence of Nerve Integrity and Vocal Cord Functions EMG+ IOVL+	68 nerves at risk
Frequency of Congruence of Nerve Integrity and Vocal Cord Functions EMG+ IOVL-	13 nerves at risk
Frequency of Congruence of Nerve Integrity and Vocal Cord Functions EMG- IOVL-	17 nerves at risk
Frequency of Congruence of Nerve Integrity and Vocal Cord Functions EMG- IOVL+	10 nerves at risk

Adverse Events

Intraoperative Video Laryngoscopy

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	Intraoperative Video Laryngoscopy n=75 participants at risk 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
Injury, poisoning and procedural complications Tracheostomy	1.3% 1/75 • 3 months Definition of adverse event from 21 CFR 312.32 (a): any untoward medical occurrence associated with the use of an intervention in humans, whether or not considered intervention-related.

Other adverse events

Measure	Intraoperative Video Laryngoscopy n=75 participants at risk 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
Injury, poisoning and procedural complications Transected nerve intraoperatively	1.3% 1/75 • 3 months Definition of adverse event from 21 CFR 312.32 (a): any untoward medical occurrence associated with the use of an intervention in humans, whether or not considered intervention-related.
Injury, poisoning and procedural complications reintubation and a tracheostomy immediately postoperatively	1.3% 1/75 • 3 months Definition of adverse event from 21 CFR 312.32 (a): any untoward medical occurrence associated with the use of an intervention in humans, whether or not considered intervention-related.

Additional Information

Dr. David Steinmetz

Icahn School of Medicine at Mount Sinai

Phone: 646-831-5950

Email: dsteinmetz0@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place