Vocal Cord Paresis Clinical Trial
Official title:
The Incidence and Impact of Vocal Cord Dysfunction In Patients Undergoing Thoracic Surgery
NCT number | NCT02996526 |
Other study ID # | SSMGAD2016 |
Secondary ID | |
Status | Completed |
Phase | |
First received | |
Last updated | |
Start date | September 1, 2016 |
Est. completion date | April 7, 2018 |
Verified date | January 2020 |
Source | University of Manitoba |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
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.
Status | Completed |
Enrollment | 173 |
Est. completion date | April 7, 2018 |
Est. primary completion date | January 31, 2018 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Canada | Health Sciences Centre | Winnipeg | Manitoba |
Lead Sponsor | Collaborator |
---|---|
University of Manitoba |
Canada,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of patients with vocal cord dysfunction assessed by nasolaryngoscopy on the first post-operative day | Post-operative day 1 | ||
Secondary | Number of patients with respiratory complictions | Within 30 days of operation | ||
Secondary | Number of patients with vocal cord dysfunction assessed by nasolaryngoscopy prior to operation | Day of operation | ||
Secondary | Hospital length of stay | Number of days between admission to hospital and discharge | From date of primary operation to discharge | |
Secondary | The number of patients with swallowing difficulties, cardiac complications and who have died | From the date of operation to day 30 after operation | ||
Secondary | ICU length of stay | 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. | From date of operation to discharge from hospital | |
Secondary | Readmission to hospital | Number of readmission episodes after initial discharge and during the 90 day period after surgery | From day of surgery to day 90 after operation |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
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