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

NCT02996526 | Completed

• 1 other identifier: SSMGAD2016
• Study Type: observational
• Target: 173
• Locations: 1 country
• Sites: 1

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.

Conditions

Vocal Cord Paresis; Acquired Vocal Cord Palsy

Keywords

vocal cord palsy dysfunction thoracic surgery complication

Outcome Measures

Primary Outcomes (1)

• Number of patients with vocal cord dysfunction assessed by nasolaryngoscopy on the first post-operative day

  Post-operative day 1

Secondary Outcomes (6)

• Number of patients with respiratory complictions

  Within 30 days of operation

• Number of patients with vocal cord dysfunction assessed by nasolaryngoscopy prior to operation

  Day of operation

• Hospital length of stay

  From date of primary operation to discharge

• The number of patients with swallowing difficulties, cardiac complications and who have died

  From the date of operation to day 30 after operation

• ICU length of stay

  From date of operation to discharge from hospital

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

Sponsors & Collaborators

• University of Manitoba: lead

Study Sites (1)

Health Sciences Centre

Winnipeg, Manitoba, R3A1R9, Canada

Location

MeSH Terms

Conditions

Vocal Cord Paralysis

Condition Hierarchy (Ancestors)

Laryngeal Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases; Vagus Nerve Diseases; Cranial Nerve Diseases; Nervous System Diseases; Paralysis; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Sadeesh Srinathan, MD

  University of Manitoba

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Sadeesh Srinathan Associate Professor Section of Thoracic Surgery

Study Record Dates

• First Submitted: August 19, 2016
• First Posted: December 19, 2016
• Study Start: September 1, 2016
• Primary Completion: January 31, 2018
• Study Completion: April 7, 2018
• Last Updated: January 31, 2020

Record last verified: 2020-01

Locations

CA (1)