Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05193240

Predictive Value of a Preliminary Swallowing Test Compared to Postoperative Nasofibroscopy to Identify Vocal Cord Paralysis After Pulmonary Resection

Led by University Hospital, Rouen · Updated on 2026-02-17

72

Participants Needed

1

Research Sites

85 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

Predictive Value of a Preliminary Swallowing Test Compared to Postoperative Nasofibroscopy to Identify Vocal Cord Paralysis After Pulmonary Resection

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults 18 years or older
  • Scheduled for major left lung resection surgery (segmentectomy, lobectomy, pneumonectomy) or right lung resection with upper lymph node dissection for lung cancer
  • Able to read and understand the patient information and consent form
  • Able to sign the consent form
  • Have social insurance
  • Women of childbearing age using effective contraception or postmenopausal for at least 12 months not due to therapy
  • Negative urine pregnancy test
Not Eligible

You will not qualify if you...

  • History of swallowing or eating disorders
  • Neurological history with known after-effects or cognitive disorders
  • Preoperative nasogastric tube feeding
  • Under legal restriction or judicial protection such as guardianship or curatorship
  • Pregnant or breastfeeding women
  • Participation in another clinical trial with the same primary outcome

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

Trial Site Locations

Total: 1 location

1

Rouen University Hospital

Rouen, France

Actively Recruiting

Loading map...

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here