NCT05193240Recruiting
Predictive Value of a Preliminary Swallowing Test Compared to Postoperative Nasofibroscopy to Identify Vocal Cord Paralysis After Pulmonary Resection
Source: ClinicalTrials.gov · Last updated 17 Feb 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 72 (estimated)
- First submitted
- 27 Dec 2021
- Start date
- 11 Sept 2024
- Primary completion date
- May 2026
- Lead sponsor
- University Hospital, Rouen
- Diseases
- Lung cancer
- NCT number
- NCT05193240
What you commit to
- Study type: Interventional
- Planned participants: 72
- From 11 Sept 2024 to the primary completion date, May 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- History of swallowing or eating disorders,
- Neurological history with known sequelae or cognitive disorders
Other
- 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
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Rouen University Hospital Coordinator of this site? Confirm its status | Rouen | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.