Comparison of Two Technique for Assessment of Vocal Cord Movement by C-Mac Videolaryngoscope vs Airway Ultrasound.

June 16, 2020 updated by: Amit Kumar Mittal, Rajiv Gandhi Cancer Institute & Research Center, India

Assessment of Vocal Cord Movement After Thyroid Surgery Using C-MAC Video-laryngoscope and Airway Ultrasound.

This study is planned to compare C-Mac video-laryngoscope and airway ultrasound as two novel techniques (causing least discomfort to the patients) for the detection of impaired vocal-cord movement after thyroid surgery.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

In this prospective study 100 patients posted for Thyroid surgery will be included, after explaining the procedure and written informed consent, all included patients in the study will be assessed for vocal cord mobility by C-Mac video laryngoscope (manufactured by KARL STORZ Video Laryngoscopes) followed by airway ultrasonography (USG). Linear transducer (7.5 MHz) will be used for scanning the airway placed at the level of thyroid cartilage with 10-15 degree cephalad tilt so to get proper acoustic window and for optimal visualization of laryngeal structures. C-Mac video laryngoscope will be required for virtual visualization of glottis apertures and vocal cord movement. All patients will be scanned pre-operatively by indirect laryngoscopy to see vocal cord mobility as a reference value. Immediately after extubation the patient will be scanned for vocal cord mobility by videolaryngoscope by first examiner, After oxygenation and stabilization of haemodynamic, ultrasound of airway will be performed to study the vocal cord movement by the other examiner (blinded to the laryngoscopy finding).Visibility of false vocal cords, true vocal cords and arytenoids will be given one point each for one side, maximal score will be 6. According to points the acoustic window scoring for glottis aperture will be graded as fair (score1-2), good(score3-4) and very good(score5-6) Findings of both the examiners will be collected by the primary investigator for data collection and analysis.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • India
    • New Delhi
      • Rohini, New Delhi, India, 110085
        • Rajiv Gandhi Cancer Institute & Research Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

17 years to 70 years (ADULT, OLDER_ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Patient's undergoing thyroid and parathyroid surgery.

Exclusion Criteria:

  • patients not extubated.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
ACTIVE_COMPARATOR: C-Mac video laryngoscope.
Active Comparator: C-Mac Videolaryngoscope for vocal cord movement assessment.
Device: Active Comparator :C-Mac Videolaryngoscope
Real time assessment of Glottic aperture at the time of extubation by videolaryngoscope
Device: Experimental: Airway ultrasound,
Airway ultrasound using portable ultrasound machine to assess vocal cords movement.
EXPERIMENTAL: Airway Ultrasound
Experimental: Airway Ultrasound for vocal cord movement assessment.
Device: Active Comparator :C-Mac Videolaryngoscope
Real time assessment of Glottic aperture at the time of extubation by videolaryngoscope
Device: Experimental: Airway ultrasound,
Airway ultrasound using portable ultrasound machine to assess vocal cords movement.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
• To determine objective vocal cord mobility by the video laryngoscope and airway ultrasound
Time Frame: At time of extubation.
patients vocal cords will be assessed by videolaryngoscope at time of extubation then the cords will be again assessed by airway ultrasound.
At time of extubation.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
• To ascertain whether airway ultrasound can be used as a reliable alternative to assess post-operative vocal cord mobility
Time Frame: After extubation and before dressing.
After extubation with aseptic precaution patient's airway will be scanned for vocal cord movement assessment.
After extubation and before dressing.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Rajiv Gandhi Cancer Institute & Research Center, India

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Amit kr Mittal, M.D, Rajiv Gandhi Cancer Institute & Research Centre, Rohini; New Delhi: India 110085.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 20, 2016

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 19, 2017

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 10, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 25, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 27, 2016

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 28, 2016

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 17, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2017

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 505/AN/AKM-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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