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Trial record 64 of 186 for:    GLYCOPYRROLATE

Intraoperative Video Laryngoscopy as Adjunct for Nerve Monitoring (IOVL)

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ClinicalTrials.gov Identifier: NCT03742141
Recruitment Status : Recruiting
First Posted : November 15, 2018
Last Update Posted : November 15, 2018
Sponsor:
Collaborator:
NeuroVision
Information provided by (Responsible Party):
Randall Owen, Icahn School of Medicine at Mount Sinai

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.

Condition or disease Intervention/treatment Phase
Vocal Cord Function in Neck Procedures Device: Intraoperative Video Laryngoscopy Drug: Glycopyrrolate Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 125 participants
Intervention Model: Single Group Assignment
Intervention Model Description: All patients enrolled in the study will be in a single group.
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Intraoperative Video Laryngoscopy as Adjunct for Nerve Monitoring
Actual Study Start Date : October 17, 2018
Estimated Primary Completion Date : September 26, 2020
Estimated Study Completion Date : September 26, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Intraoperative Video Laryngoscopy
Participants undergoing neck procedures
Device: Intraoperative Video Laryngoscopy
The IOVL is a disposable, otherwise standard fiberoptic laryngoscope that is inserted alongside the endotracheal tube following intubation for surgical procedures.
Other Name: IOVL

Drug: Glycopyrrolate
0.004mg/kg as per routine prior to intubation




Primary Outcome Measures :
  1. Frequency of congruence [ Time Frame: during intraoperative procedure ]
    Frequency of congruence between IOVL and the intraoperative nerve monitoring data.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03742141


Contacts
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Contact: Margaret Hofstedt, BS 212-241-1474 margaret.hofstedt@mountsinai.org
Contact: Abiba Salahou, BA 212-241-8250 abiba.salahou@mountsinai.org

Locations
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United States, New York
Mount Sinai Queens Not yet recruiting
Long Island City, New York, United States, 11102
Mount Sinai Beth Israel Recruiting
New York, New York, United States, 10003
Mount Sinai West Recruiting
New York, New York, United States, 10019
Mount Sinai St. Luke's Recruiting
New York, New York, United States, 10025
The Mount Sinai Hospital Recruiting
New York, New York, United States, 10029
Sponsors and Collaborators
Icahn School of Medicine at Mount Sinai
NeuroVision
Investigators
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Principal Investigator: Randall Owen, MD Icahn School of Medicine at Mount Sinai

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Responsible Party: Randall Owen, Associate Professor, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT03742141     History of Changes
Other Study ID Numbers: GCO 17-2617
First Posted: November 15, 2018    Key Record Dates
Last Update Posted: November 15, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Keywords provided by Randall Owen, Icahn School of Medicine at Mount Sinai:
Thyroidectomy
Neck Procedures
Nerve Monitoring
Additional relevant MeSH terms:
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Glycopyrrolate
Adjuvants, Anesthesia
Muscarinic Antagonists
Cholinergic Antagonists
Cholinergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs