Vocal Cord ParesisNCT02996526
The Incidence and Impact of Vocal Cord Dysfunction In Patients Undergoing Thoracic Surgery
An observational study of Vocal Cord Paresis and Acquired Vocal Cord Palsy, run by University of Manitoba at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Vocal Cord Paresis, Acquired Vocal Cord Palsy
- How many people
- 173 participants
- Where
- 1 siteCanada
- Study dates
- 1 Sep 2016to 7 Apr 2018
- How long will I take part?
- 3 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Objectives:
Primary: Estimate the prevalence of vocal cord dysfunction after thoracic surgery and the association of vocal cord dysfunction and immediate post operative respiratory complication after thoracic surgery.
Secondary:
- Estimate the prevalence of vocal cord dysfunction in the pre-operative patient population undergoing thoracic surgery, i.e. the baseline prevalence.
- Estimate the incidence of new vocal cord dysfunction in the post-operative period, i.e. the incidence of new dysfunction
- Estimate the association of vocal cord dysfunction and respiratory, voice, swallowing, and mortality outcomes
- Estimate the impact of vocal cord immobility on hospital length of stay, ICU admission rates and duration
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
Schematic of Study Design:
Enrollment Vocal Cord Mobility Assessment 1
Total N=141: Obtain informed consent. Screen potential participants by inclusion and exclusion criteria; obtain history Perform Flexible Nasolaryngoscopy by otolaryngology resident, document by videorecording
Vocal Cord Mobility Assessment 2 Post operative day 1-2 Perform Flexible Nasolaryngoscopy by otolaryngology resident, document by videorecording
Collection of functional outcomes Hospital Discharge or Death Collection of data on respiratory, voice, swallowing, cardiovascular mortality outcomes, hospital length of stay and ICU admission duration
Review of Vocal Cord Mobility Assessment by expert (Laryngologist) by review of videorecordings of nasolaryngoscopy
Statistical Analysis Final Assessments Association of vocal cord immobility and functional outcomes and death.
2.1 Background Information Research Question: In patients undergoing thoracic surgery, what is the incidence of respiratory and associated complications in the 30 day post-operative period among those with/without Recurrent Laryngeal Nerve (RLN) Injury?
Background: The issue of RLN injury is an important clinical challenge in thoracic surgery, as respiratory complications are the greatest source of morbidity in our surgical population . Clinical care experience and the literature demonstrate a high incidence of respiratory complications (20-60% incidence of pneumonia for esophagectomy and a 20% death rate for those who contract pneumonia) in the post-operative thoracic surgery population.
The thoracic surgery population is at uniquely elevated risk for respiratory complications due to the high prevalence of COPD, the nature of the primary surgical procedure directly diminishing pulmonary function and toilet; and possible RLN injury. The only modifiable element of this triad is RLN injury, and appears to be the most important element based on clinical experience and the limited literature available. The RLN supplies motor innervation to the vocal cords; vocal cord closure is considered the most important protective mechanism against aspiration into the lungs . Patients with a RLN injury demonstrate a 5-fold risk of contracting pneumonia, a 5-fold risk of reintubation or tracheostomy , and have 40-60% longer hospital stays than patients without RLN injury.
The current literature base is substantially lacking with regards to the incidence of RLN injury, with estimates varying from 4-80% based on retrospective reviews or prospective studies which fail to examine all patients. The highest quality studies demonstrate a RLN injury rate in the range of 20-40% for major procedures such as esophagectomy and pneumonectomy.
With the recent advent of injection laryngoplasty for vocal cord medialization, there is now a practical means of potentially altering the course of this pathologic triad. This procedure can be performed at the bedside under local anesthetic, allowing for early intervention in this high-risk population as a bulwark against aspiration.
Prospectively examining the incidence of pre and post-operative vocal cord immobility in all thoracic surgery patients is the only means to quantify the health burden associated with RLN injury.
Potential Risks Potential risks of the study include time involved in considering participation, providing consent and data such as subjective voice quality and undergoing flexible nasolaryngoscopy to assess vocal cord status. No health, economic or legal risks are anticipated for the participants.
Potential Benefits No direct benefit, either monetary or health improvement will accrue to patients from participation in the study.
Study Outcome Measures Vocal Cord Mobility - Flexible nasolaryngoscopy to visualize mobility status of vocal cords.
Voice - Voice Handicap Index 10. Validated instrument used for subjective assessment of voice, 10 plain language questions answered by the patient.
Respiratory: Incidence of pneumonia (as defined by CDC criteria) and intubation Swallowing: Oral diet vs NPO and diet texture tolerated at discharge Cardiovascular: Myocardial Infarction as defined by the third universal criteria 2012 by third ESC/ACCF/AHA/WHF, Cerebrovascular Accident as defined by WHO MONICA criteria and Neurology specialist consultation
- Conditions
- Vocal Cord Paresis, Acquired Vocal Cord Palsy
- Keywords
- vocal cord palsy dysfunction thoracic surgery complication
- Medical subject headings
- Vocal Cord Paralysis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients with vocal cord dysfunction assessed by nasolaryngoscopy on the first post-operative day
Measured: Post-operative day 1
Secondary outcomes (6)
Number of patients with respiratory complictions
Measured: Within 30 days of operation
Number of patients with vocal cord dysfunction assessed by nasolaryngoscopy prior to operation
Measured: Day of operation
Hospital length of stay
Number of days between admission to hospital and discharge
Measured: From date of primary operation to discharge
The number of patients with swallowing difficulties, cardiac complications and who have died
Measured: From the date of operation to day 30 after operation
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.
Measured: From date of operation to discharge from hospital
Readmission to hospital
Number of readmission episodes after initial discharge and during the 90 day period after surgery
Measured: From day of surgery to day 90 after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2016 (estimated)
- Study start1 Sep 2016
- Primary completion31 Jan 2018
- Study completion7 Apr 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Vocal Cord ParesisStudies of the same condition, open and under way.
- More trials run by University of ManitobaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 173 participants (actual)
- Target duration
- 3 Months
Sponsor and investigators
- Lead sponsor
- University of Manitoba
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sadeesh Srinathan, MD, University of Manitoba
- Investigators
- Sadeesh Srinathan, MD, Principal investigator, University of Manitoba
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02996526
- Sponsor's protocol ID
- SSMGAD2016
- Status last verified
- Jan 2020
- First submitted
- 19 Aug 2016
- Last updated
- 31 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Incidence and Impact of Vocal Cord Dysfunction In Patients Undergoing Thoracic Surgery
- ClinicalTrials.gov ID
- NCT02996526
- Acronym / sponsor ID
- SSMGAD2016
- Conditions
- Vocal Cord Paresis, Acquired Vocal Cord Palsy
- Keywords
- vocal cord palsy dysfunction thoracic surgery complication
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 173 participants (actual)
- Lead sponsor
- University of ManitobaUniversity, hospital or other
- Study start
- 1 Sep 2016 (actual)
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 7 Apr 2018 (actual)
- First posted
- 19 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Objectives:
Primary: Estimate the prevalence of vocal cord dysfunction after thoracic surgery and the association of vocal cord dysfunction and immediate post operative respiratory complication after thoracic surgery.
Secondary:
- Estimate the prevalence of vocal cord dysfunction in the pre-operative patient population undergoing thoracic surgery, i.e. the baseline prevalence.
- Estimate the incidence of new vocal cord dysfunction in the post-operative period, i.e. the incidence of new dysfunction
- Estimate the association of vocal cord dysfunction and respiratory, voice, swallowing, and mortality outcomes
- Estimate the impact of vocal cord immobility on hospital length of stay, ICU admission rates and duration
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
Schematic of Study Design:
Enrollment Vocal Cord Mobility Assessment 1
Total N=141: Obtain informed consent. Screen potential participants by inclusion and exclusion criteria; obtain history Perform Flexible Nasolaryngoscopy by otolaryngology resident, document by videorecording
Vocal Cord Mobility Assessment 2 Post operative day 1-2 Perform Flexible Nasolaryngoscopy by otolaryngology resident, document by videorecording
Collection of functional outcomes Hospital Discharge or Death Collection of data on respiratory, voice, swallowing, cardiovascular mortality outcomes, hospital length of stay and ICU admission duration
Review of Vocal Cord Mobility Assessment by expert (Laryngologist) by review of videorecordings of nasolaryngoscopy
Statistical Analysis Final Assessments Association of vocal cord immobility and functional outcomes and death.
2.1 Background Information Research Question: In patients undergoing thoracic surgery, what is the incidence of respiratory and associated complications in the 30 day post-operative period among those with/without Recurrent Laryngeal Nerve (RLN) Injury?
Background: The issue of RLN injury is an important clinical challenge in thoracic surgery, as respiratory complications are the greatest source of morbidity in our surgical population . Clinical care experience and the literature demonstrate a high incidence of respiratory complications (20-60% incidence of pneumonia for esophagectomy and a 20% death rate for those who contract pneumonia) in the post-operative thoracic surgery population.
The thoracic surgery population is at uniquely elevated risk for respiratory complications due to the high prevalence of COPD, the nature of the primary surgical procedure directly diminishing pulmonary function and toilet; and possible RLN injury. The only modifiable element of this triad is RLN injury, and appears to be the most important element based on clinical experience and the limited literature available. The RLN supplies motor innervation to the vocal cords; vocal cord closure is considered the most important protective mechanism against aspiration into the lungs . Patients with a RLN injury demonstrate a 5-fold risk of contracting pneumonia, a 5-fold risk of reintubation or tracheostomy , and have 40-60% longer hospital stays than patients without RLN injury.
The current literature base is substantially lacking with regards to the incidence of RLN injury, with estimates varying from 4-80% based on retrospective reviews or prospective studies which fail to examine all patients. The highest quality studies demonstrate a RLN injury rate in the range of 20-40% for major procedures such as esophagectomy and pneumonectomy.
With the recent advent of injection laryngoplasty for vocal cord medialization, there is now a practical means of potentially altering the course of this pathologic triad. This procedure can be performed at the bedside under local anesthetic, allowing for early intervention in this high-risk population as a bulwark against aspiration.
Prospectively examining the incidence of pre and post-operative vocal cord immobility in all thoracic surgery patients is the only means to quantify the health burden associated with RLN injury.
Potential Risks Potential risks of the study include time involved in considering participation, providing consent and data such as subjective voice quality and undergoing flexible nasolaryngoscopy to assess vocal cord status. No health, economic or legal risks are anticipated for the participants.
Potential Benefits No direct benefit, either monetary or health improvement will accrue to patients from participation in the study.
Study Outcome Measures Vocal Cord Mobility - Flexible nasolaryngoscopy to visualize mobility status of vocal cords.
Voice - Voice Handicap Index 10. Validated instrument used for subjective assessment of voice, 10 plain language questions answered by the patient.
Respiratory: Incidence of pneumonia (as defined by CDC criteria) and intubation Swallowing: Oral diet vs NPO and diet texture tolerated at discharge Cardiovascular: Myocardial Infarction as defined by the third universal criteria 2012 by third ESC/ACCF/AHA/WHF, Cerebrovascular Accident as defined by WHO MONICA criteria and Neurology specialist consultation
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Months
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (6 listed)
- 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..
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Number of patients with vocal cord dysfunction assessed by nasolaryngoscopy on the first post-operative day
Time frame: Post-operative day 1
6 secondary outcomes
Number of patients with respiratory complictions
Time frame: Within 30 days of operation
Number of patients with vocal cord dysfunction assessed by nasolaryngoscopy prior to operation
Time frame: Day of operation
Hospital length of stay
Time frame: From date of primary operation to discharge
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
ICU length of stay
Time frame: From date of operation to discharge from hospital
Readmission to hospital
Time frame: From day of surgery to day 90 after operation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2020.
- Individual participant dataSharing planned: Undecided
Related trials for Vocal Cord Paresis
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Usefulness and Feasibility of Ultrasound in Office Laryngology Procedures
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Detection of Vocal Fold Motion Impairment on Noninvasive Positive Pressure
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sadeesh Srinathan, MD principal investigator
University of Manitoba
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vocal Cord Paresis and Acquired Vocal Cord Palsy, run by University of Manitoba at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients with vocal cord dysfunction assessed by nasolaryngoscopy on the first post-operative day (time frame: Post-operative day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2020.