Adults Patients Undergoing Major Lung Resection in the Context of Lung CancerSwaLONCT05193240
Predictive Value of a Preliminary Swallowing Test Compared to Postoperative Nasofibroscopy to Identify Vocal Cord Paralysis After Pulmonary Resection
A study testing preliminary swallowing test in people with Adults Patients Undergoing Major Lung Resection in the Context of Lung Cancer, run by University Hospital, Rouen at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adults Patients Undergoing Major Lung Resection in the Context of Lung Cancer
- What is being tested?
- preliminary swallowing test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- 1 siteFrance
- Study dates
- 11 Sep 2024to May 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Rouen University Hospital
Rouen
Baptiste MICHAUX, 02 32 88 82 61, baptiste.michaux@chu-rouen.fr
Déborah LEBEDIEFF, +33232888265, deborah.lebedieff@chu-rouen.fr
About this study
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.
Read more
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.
- Being tested
- preliminary swallowing test
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preliminary swallowing testDiagnostic test
Also called nasofibroscopy, ultrasound examination of the vocal cords
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.
| Study group | Role | What they receive |
|---|---|---|
| preliminary swallowing test | Experimental | compared as nasofibroscopy and ultrasound examination of vocal cords Receives: Diagnostic Test: preliminary swallowing test |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 hours after extubation to 24 hours after extubation
Secondary outcomes (7)
Prevalence of swallowing disorders pre-existing to planned surgery,
established according to the results of the swallowing test carried out by a physiotherapist
Measured: inclusion
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
Measured: 2 hours after extubation to 24 hours after extubation
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
Measured: 2 hours after extubation to 24 hours after extubation
- 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
Measured: Between (2 hours after extubation to 24 hours after extubation) and Day 4
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
Measured: Between (2 hours after extubation to 24 hours after extubation) and Day 4
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
Measured: 2 hours after extubation to 24 hours after extubation
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.
Measured: 30 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2022
- Study start11 Sep 2024
- Primary completionMay 2026 (estimated)
- Study completionMay 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adults Patients Undergoing Major Lung Resection in the Context of Lung CancerStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Baptiste MICHAUX, physiotherapist, Principal investigator, University Hospital, Rouen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05193240
- Sponsor's protocol ID
- 2020/0419/HP
- Acronym
- SwaLO
- Status last verified
- Feb 2026
- First submitted
- 27 Dec 2021
- Last updated
- 17 Feb 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Predictive Value of a Preliminary Swallowing Test Compared to Postoperative Nasofibroscopy to Identify Vocal Cord Paralysis After Pulmonary Resection
- ClinicalTrials.gov ID
- NCT05193240
- Acronym / sponsor ID
- SwaLO / 2020/0419/HP
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Study start
- 11 Sep 2024 (actual)
- Primary completion
- May 2026 (estimated)
- Study completion
- May 2026 (estimated)
- First posted
- 14 Jan 2022 (actual)
- 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.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| preliminary swallowing test | Experimental | Diagnostic Test: preliminary swallowing testcompared as nasofibroscopy and ultrasound examination of vocal cords |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| preliminary swallowing testAlso: nasofibroscopy, ultrasound examination of the vocal cordsPatients 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. | Diagnostic test | preliminary swallowing test |
Primary outcome
discreapancies between preliminary swallowing test and nasofibroscopy
Time frame: 2 hours after extubation to 24 hours after extubation
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
7 secondary outcomes
Prevalence of swallowing disorders pre-existing to planned surgery,
Time frame: inclusion
performance of the preliminary swallowing test
Time frame: 2 hours after extubation to 24 hours after extubation
Performance of the ultrasound examination
Time frame: 2 hours after extubation to 24 hours after extubation
- 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
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
Assessment of the discomfort felt during the 3 tests
Time frame: 2 hours after extubation to 24 hours after extubation
Prevalence of postoperative complications according to the grade of the Clavien-Dindo classification
Time frame: 30 days after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Individual participant dataSharing planned: No
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.
Baptiste MICHAUX, physiotherapist principal investigator
University Hospital, Rouen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing preliminary swallowing test in people with Adults Patients Undergoing Major Lung Resection in the Context of Lung Cancer, run by University Hospital, Rouen at 1 site in France.
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 7 inclusion and 6 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: looking for participants now, as of the sponsor's last update on 17 Feb 2026. 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 France. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
discreapancies between preliminary swallowing test and nasofibroscopy (time frame: 2 hours after extubation to 24 hours after extubation). 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 17 Feb 2026.