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Trial record 2 of 5 for:    Recruiting, Not yet recruiting, Available Studies | "Vocal Cord Dysfunction"

The Incidence and Impact of Vocal Cord Dysfunction In Patients Undergoing Thoracic Surgery

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ClinicalTrials.gov Identifier: NCT02996526
Recruitment Status : Recruiting
First Posted : December 19, 2016
Last Update Posted : October 26, 2017
Sponsor:
Information provided by (Responsible Party):
Sadeesh Srinathan, MD, University of Manitoba

Brief Summary:
Population-based single centre, blinded, prospective cohort study of the impact of recurrent laryngeal nerve (RLN) injury on Thoracic Surgery patients. The principal outcome of interest is the effect of RLN injury on respiratory complications. Voice, swallowing, cardiac and mortality outcomes will also be determined.

Condition or disease
Vocal Cord Paresis Acquired Vocal Cord Palsy

  Show Detailed Description

Study Type : Observational [Patient Registry]
Estimated Enrollment : 141 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 3 Months
Official Title: The Incidence and Impact of Vocal Cord Dysfunction In Patients Undergoing Thoracic Surgery
Study Start Date : August 2016
Estimated Primary Completion Date : August 2018
Estimated Study Completion Date : December 2018

Group/Cohort
Intact Vocal Cord Mobility
Patients with normal laryngeal function post thoracic surgery
Vocal Cord Dysfunction
Patients with abnormal vocal cord movement of 1 or both vocal cords post thoracic surgery



Primary Outcome Measures :
  1. Number of patients with vocal cord dysfunction assessed by nasolaryngoscopy on the first post-operative day [ Time Frame: Post-operative day 1 ]

Secondary Outcome Measures :
  1. Number of patients with respiratory complictions [ Time Frame: Within 30 days of operation ]
  2. Number of patients with vocal cord dysfunction assessed by nasolaryngoscopy prior to operation [ Time Frame: Day of operation ]
  3. Hospital length of stay [ Time Frame: From date of primary operation to discharge ]
    Number of days between admission to hospital and discharge

  4. The number of patients with swallowing difficulties, cardiac complications and who have died [ Time Frame: From the date of operation to day 30 after operation ]
  5. ICU length of stay [ Time Frame: From date of operation to discharge from hospital ]
    The total number of days admitted to the intensive care unit (a facility where full ventilator support and inotropic support can be provided) If more than one admission episode to the ICU, the total number of days in the ICU census is counted across the multiple admission episodes.

  6. Readmission to hospital [ Time Frame: From day of surgery to day 90 after operation ]
    Number of readmission episodes after initial discharge and during the 90 day period after surgery



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients undergoing thoracic surgery at Health Sciences Centre in Winnipeg, Canada. This is a tertiary care centre with a population-based referral base of 1.5 million people.
Criteria

Inclusion Criteria:

  • All patients undergoing thoracic surgery at Health Sciences Centre Winnipeg. Recruitment will be performed by the thoracic surgeon faculty within the Division of Thoracic Surgery. Written informed consent will be obtained from the patient by an independent research assistant.

In order to be eligible to participate in this study, an individual must meet all of the following criteria:

  • Provide signed and dated informed consent form.
  • Willing to comply with all study procedures and be available for the duration of the study.
  • Male or female, aged 18 and over..
  • Have a condition requiring surgical entry into the thoracic cavity

Exclusion Criteria:

  • All individuals meeting any of the exclusion criteria at baseline will be excluded from the study. Patients with severely deviated nasal anatomy precluding flexible nasolaryngoscopy Tracheostomy in situ Neurologic or developmental deficits impairing the ability to consent or cooperate with examination

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): NCT02996526


Contacts
Contact: Sadeesh Srinathan, MD 204-7874587 ssrinathan@exchange.hsc.mb.ca
Contact: Michael Gousseau, MD 204-787-3349 umgousse@myumanitoba.ca

Locations
Canada, Manitoba
Health Sciences Centre Recruiting
Winnipeg, Manitoba, Canada, R3A1R9
Contact: Sadeesh Srinathan, MD, FRCS    2047873791      
Principal Investigator: Sadeesh Srinathan, MD, FRCS         
Sponsors and Collaborators
University of Manitoba
Investigators
Principal Investigator: Sadeesh Srinathan, MD University of Manitoba

Responsible Party: Sadeesh Srinathan, MD, Dr. Sadeesh Srinathan Associate Professor Section of Thoracic Surgery, University of Manitoba
ClinicalTrials.gov Identifier: NCT02996526     History of Changes
Other Study ID Numbers: SSMGAD2016
First Posted: December 19, 2016    Key Record Dates
Last Update Posted: October 26, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Sadeesh Srinathan, MD, University of Manitoba:
vocal cord palsy dysfunction thoracic surgery complication

Additional relevant MeSH terms:
Vocal Cord Dysfunction
Paresis
Vocal Cord Paralysis
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Laryngeal Diseases
Respiratory Tract Diseases
Respiration Disorders
Otorhinolaryngologic Diseases
Vagus Nerve Diseases
Cranial Nerve Diseases
Paralysis