Rouen University Hospital
Rouen, France
Location status: Recruiting
Location contact
Baptiste MICHAUX
CONTACT
Déborah LEBEDIEFF
CONTACT
NCT Number: NCT05193240
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Rouen, France
Location status: Recruiting
Baptiste MICHAUX
CONTACT
Déborah LEBEDIEFF
CONTACT
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Other names: nasofibroscopy, ultrasound examination of the vocal cords
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
Time frame: inclusion
established according to the results of the swallowing test carried out by a physiotherapist
Time frame: 2 hours after extubation to 24 hours after extubation
Time frame: 2 hours after extubation to 24 hours after extubation
Time frame: Between (2 hours after extubation to 24 hours after extubation) and Day 4
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: 2 hours after extubation to 24 hours after extubation
Assessment of the discomfort felt during the 3 tests carried out using a numerical scale from 0 to 10
Time frame: 30 days after surgery
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.
University Hospital, Rouen
Other
Acronym: SwaLO
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.