Prevalence of Tapia's Syndrome in Weaning Unit
ConditionTapia's Syndrome
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorHopital Forcilles
About this trial
Tapia syndrome is a rare and poorly understood pathology. It is defined by a concomitant attack of the recurrent (branch of X) and hypoglossal (XII) nerves of peripheral or central origin. It is characterized by the paralysis of a vocal cord and the ipsilateral half of tongue. This damage is most often unilateral but it can also be bilateral. It results in dysphonia and swallowing disorders.
Tapia syndrome is a rare and poorly understood pathology. To date, less than 100 cases have been described in the literature. Previous works are mainly case reports and literature reviews. No prevalence study has been performed to date. Furthermore, disagreements persist regarding the semiology. Indeed, the involvement of the soft palate is not always described.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Hospitalized in weaning unit
Duration of orotracheal intubation in the ICU greater than 48 hours;
Glasgow score greater than or equal to 13 ;
Patient at least 18 years of age at the time of inclusion;
Disqualifiers
Known history of ENT or neurological pathologies (stroke, head trauma, neurodegenerative disease, brain tumor, ENT cancer);
Known tumors in the vicinity of the X-nerve pathway;
Ortner's syndrome (left recurrent nerve compression through the left atrium in mitral stenosis);
Left lung cancer with subaortic lesion;
Trial population
Patients who were intubated during more than 48 hours in ICU then tracheostomized and hospitalized in weaning unit.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Diagnosis of Tapia's Syndrome
Diagnostic testThe diagnostic includes : * Lingual clinical examination * Nasofibroscopy * Ultrasonography
Treatment groups
247 Participants
are divided into 2 treatment groupsGroup A: "Non Tapia group"1 intervention
Group B: "Tapia group"1 intervention
Trial outcomes
Primary outcomes
1
Prevalence of Tapia's syndrome
The main objective of this study is to determine the prevalence of Tapia syndrome in patients admitted to the weaning unit after prolonged orotracheal intubation in intensive care. The orotracheal intubation is defined as an intubation longer than 48 hours.
Time frame
through study completion, an average of 2 yearsSecondary outcomes
1
Lingual involvment
yes/no/measure of lingual deviation in mm and width of each half of tongue in mm with MEEI software)
Time frame
through study completion, an average of 2 years2
Soft palate involvement
yes/no
Time frame
through study completion, an average of 2 years3
Determining the factors associated with Tapia syndrome
Determining the factors associated with Tapia syndrome : number of prone sessions, duration of intubation (day), duration of mechanical ventilation (day), tracheostomy duration (day), Cormack-Lehane's class, time to tracheostomy cannula removal (day), the time to resume oral feeding (day), number of days in the ICU, number of days in weaning unit, the number of pulmonary infections during the intubation and tracheostomy period, sex, the size of the intubation probe in mm
Time frame
The day of inclusion4
Dysphonia
GRBAS, maximum time of phonation (s), base frequency (Hz), jitter (%), harmonic noise ratio (dB), vocal range (dB), vocal tessitura (dB)
Time frame
After initial swallowing test, maximum 1 weekSponsors and contacts
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Source ClinicalTrials.gov