Predictive Value of a Preliminary Swallowing Test Compared to Postoperative Nasofibroscopy to Identify Vocal Cord Paralysis After Pulmonary Resection (SwaLO)
Primary Purpose
Adults Patients Undergoing Major Lung Resection in the Context of Lung Cancer
Status
Not yet recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
preliminary swallowing test
Sponsored by
About this trial
This is an interventional diagnostic trial for Adults Patients Undergoing Major Lung Resection in the Context of Lung Cancer
Eligibility Criteria
Inclusion Criteria:
- Adult (≥ 18 years old)
- Patient who is scheduled for a major left lung resection surgery (segmentectomy, lobectomy, pneumonectomy) or a right lung resection with upper lymph node dissection in the context of lung cancer
- Patient who capable to read and understand the patient information and consent.
- Patient capable to read and sign the consent form
- Patient with social insurance
- Woman of childbearing age with effective contraception (see WHO definition), postmenopausal woman (≥ 12 months of amenorrhea not induced by therapy)
- Negative urine pregnancy test
Exclusion Criteria:
- History of swallowing or eating disorders,
- Neurological history with known sequelae or cognitive disorders
- Preoperative nasogastric tube feeding
- Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection, under guardianship or curatorship,
- Pregnant or breastfeeding woman
- Patient participating in another clinical trial with the same primary outcome
Sites / Locations
- Rouen University Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
preliminary swallowing test
Arm Description
compared as nasofibroscopy and ultrasound examination of vocal cords
Outcomes
Primary Outcome Measures
discreapancies between preliminary swallowing test and nasofibroscopy
the number of discrepancies between the two test, namely the times when the two tests do not reach the same conclusion after the patients's extubation
Secondary Outcome Measures
Prevalence of swallowing disorders pre-existing to planned surgery,
established according to the results of the swallowing test carried out by a physiotherapist
performance of the preliminary swallowing test
Sensitivity: The number of patients for whom the two tests reach the same conclusion among those with disorders according to the nasofibroscopy test
Specificity: The number of patients for whom the two tests reach the same conclusion among those who have no disorder according to the nasofibroscopy test
Performance of the ultrasound examination
Sensitivity: The number of patients for whom the two tests reach the same conclusion among those with disorders according to the nasofibroscopy test
Specificity: The number of patients for whom the two tests reach the same conclusion among those who have no disorder according to the nasofibroscopy test
- Proportion of patients for whom the score of the preliminary swallowing test on day 4 is different than that obtained for the same test carried out immediately postoperatively
- Proportion of patients for whom the score of the preliminary swallowing test on day 4 is different than that obtained for the same test carried out immediately postoperatively
Proportion of patients for whom the score of the ultrasound examination of the vocal cords on day 4 is different than that obtained for the same test carried out immediately postoperatively
Proportion of patients for whom the score of the ultrasound examination of the vocal cords on day 4 is different than that obtained for the same test carried out immediately postoperatively
Assessment of the discomfort felt during the 3 tests
Assessment of the discomfort felt during the 3 tests carried out using a numerical scale from 0 to 10
Prevalence of postoperative complications according to the grade of the Clavien-Dindo classification
Prevalence of postoperative complications according to the grade of the Clavien-Dindo classification (within 30 days after surgery). The national database EpiThor provides this information.
Full Information
NCT ID
NCT05193240
First Posted
December 27, 2021
Last Updated
March 25, 2022
Sponsor
University Hospital, Rouen
1. Study Identification
Unique Protocol Identification Number
NCT05193240
Brief Title
Predictive Value of a Preliminary Swallowing Test Compared to Postoperative Nasofibroscopy to Identify Vocal Cord Paralysis After Pulmonary Resection
Acronym
SwaLO
Official Title
Predictive Value of a Preliminary Swallowing Test Compared to Postoperative Nasofibroscopy to Identify Vocal Cord Paralysis After Pulmonary Resection
Study Type
Interventional
2. Study Status
Record Verification Date
December 2021
Overall Recruitment Status
Not yet recruiting
Study Start Date
May 2022 (Anticipated)
Primary Completion Date
May 2022 (Anticipated)
Study Completion Date
October 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Rouen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The literature describes recurrent nerve damage during thoracic surgery as a fairly complication (5 to 31% of patients). This nerve damage leads to paresis or paralysis of the ipsilateral vocal cord. This cord dysfunction no longer ensures the protective role of the airways during swallowing. This postoperative dysphagia is associated with complications such as aspiration pneumonia, the use of nasogastric tube feeding (adding difficulty to swallowing), delayed oral refeeding (risk of undernutrition, dehydration, decrease in the quality of life), and an increase in the length of hospitalization and mortality.
Identifying these patients at risk is essential to limit complications (pneumonia, reintubation, inadequate refeeding, etc.). The benchmark test to objectify vocal cord palsy is to perform a nasofibroscopy requiring equipment and the intervention of an ENT doctor or thoracic surgeon.
A physiotherapist can also perform a preliminary swallowing test by evaluating several criteria.
The aim of this study is to compare the concordance of results between nasofibroscopy and that by preliminary swallowing test, two procedures performed in the screening of vocal cord paralysis in a surgical intensive care unit and a thoracic surgery ward.
Patients will be included before the surgery. During this inclusion visit, we will perform a preoperative swallowing test.
Immediately after surgery (H2-H24 after extubation), we will perform a preliminary swallowing test, an ultrasound examination of the vocal cords and a nasofibroscopy to determine the mobility of the vocal cords. A physiotherapist will carry out the first two assessments. An ENT physician will perform the nasofibroscopy. The ENT physician performing the nasofibroscopy will not know the conclusions of the tests carried out by the physiotherapist immediately after the operation.
At last, on day 4 after extubation, we will repeat the preliminary swallowing test and the ultrasound examination to measure the evolution of cord mobility.
Initial evaluation and secondary evaluation (day 4) will be performed by two different physiotherapists in order to allow blinding between the two stages of the procedure.
45 days after the surgery, we will realize a follow-up on medical file and mark the end of the research.
We want to include 72 patients over an 18 months period.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adults Patients Undergoing Major Lung Resection in the Context of Lung Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
72 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
preliminary swallowing test
Arm Type
Experimental
Arm Description
compared as nasofibroscopy and ultrasound examination of vocal cords
Intervention Type
Diagnostic Test
Intervention Name(s)
preliminary swallowing test
Other Intervention Name(s)
nasofibroscopy, ultrasound examination of the vocal cords
Intervention Description
Patients will be included before the surgery. During this inclusion visit, we will perform a preoperative swallowing test.
Immediately after surgery (H2-H24 after extubation), we will perform a preliminary swallowing test, an ultrasound examination of the vocal cords and a nasofibroscopy to determine the mobility of the vocal cords. A physiotherapist will carry out the first two assessments. An ENT physician will perform the nasofibroscopy. The ENT physician performing the nasofibroscopy will not know the conclusions of the tests carried out by the physiotherapist immediately after the operation.
At last, on day 4 after extubation, we will repeat the preliminary swallowing test and the ultrasound examination to measure the evolution of cord mobility.
30 days after the surgery, we will realize a follow-up on medical file and mark the end of the research.
Primary Outcome Measure Information:
Title
discreapancies between preliminary swallowing test and nasofibroscopy
Description
the number of discrepancies between the two test, namely the times when the two tests do not reach the same conclusion after the patients's extubation
Time Frame
2 hours after extubation to 24 hours after extubation
Secondary Outcome Measure Information:
Title
Prevalence of swallowing disorders pre-existing to planned surgery,
Description
established according to the results of the swallowing test carried out by a physiotherapist
Time Frame
inclusion
Title
performance of the preliminary swallowing test
Description
Sensitivity: The number of patients for whom the two tests reach the same conclusion among those with disorders according to the nasofibroscopy test
Specificity: The number of patients for whom the two tests reach the same conclusion among those who have no disorder according to the nasofibroscopy test
Time Frame
2 hours after extubation to 24 hours after extubation
Title
Performance of the ultrasound examination
Description
Sensitivity: The number of patients for whom the two tests reach the same conclusion among those with disorders according to the nasofibroscopy test
Specificity: The number of patients for whom the two tests reach the same conclusion among those who have no disorder according to the nasofibroscopy test
Time Frame
2 hours after extubation to 24 hours after extubation
Title
- Proportion of patients for whom the score of the preliminary swallowing test on day 4 is different than that obtained for the same test carried out immediately postoperatively
Description
- Proportion of patients for whom the score of the preliminary swallowing test on day 4 is different than that obtained for the same test carried out immediately postoperatively
Time Frame
Between (2 hours after extubation to 24 hours after extubation) and Day 4
Title
Proportion of patients for whom the score of the ultrasound examination of the vocal cords on day 4 is different than that obtained for the same test carried out immediately postoperatively
Description
Proportion of patients for whom the score of the ultrasound examination of the vocal cords on day 4 is different than that obtained for the same test carried out immediately postoperatively
Time Frame
Between (2 hours after extubation to 24 hours after extubation) and Day 4
Title
Assessment of the discomfort felt during the 3 tests
Description
Assessment of the discomfort felt during the 3 tests carried out using a numerical scale from 0 to 10
Time Frame
2 hours after extubation to 24 hours after extubation
Title
Prevalence of postoperative complications according to the grade of the Clavien-Dindo classification
Description
Prevalence of postoperative complications according to the grade of the Clavien-Dindo classification (within 30 days after surgery). The national database EpiThor provides this information.
Time Frame
30 days after surgery
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Adult (≥ 18 years old)
Patient who is scheduled for a major left lung resection surgery (segmentectomy, lobectomy, pneumonectomy) or a right lung resection with upper lymph node dissection in the context of lung cancer
Patient who capable to read and understand the patient information and consent.
Patient capable to read and sign the consent form
Patient with social insurance
Woman of childbearing age with effective contraception (see WHO definition), postmenopausal woman (≥ 12 months of amenorrhea not induced by therapy)
Negative urine pregnancy test
Exclusion Criteria:
History of swallowing or eating disorders,
Neurological history with known sequelae or cognitive disorders
Preoperative nasogastric tube feeding
Person deprived of liberty by an administrative or judicial decision or person placed under judicial protection, under guardianship or curatorship,
Pregnant or breastfeeding woman
Patient participating in another clinical trial with the same primary outcome
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Baptiste MICHAUX, physiotherapist
Organizational Affiliation
Rouen University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rouen University Hospital
City
Rouen
Country
France
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Baptiste MICHAUX
Email
baptiste.michaux@chu-rouen.fr
First Name & Middle Initial & Last Name & Degree
Déborah LEBEDIEFF
Email
deborah.lebedieff@chu-rouen.fr
12. IPD Sharing Statement
Plan to Share IPD
No
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Predictive Value of a Preliminary Swallowing Test Compared to Postoperative Nasofibroscopy to Identify Vocal Cord Paralysis After Pulmonary Resection
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