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Benefit of PHAryngeal electrical STimulation for early de-cannulation in TRACheotomised stroke patients with neurogenic dysphagia : a prospective randomized double-blinded interventional study (PHAST TRAC study)

Laufzeit: 01.01.2015 - 31.12.2016

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Kurzfassung


The primary objective of this prospective multicentre randomized double-blinded trial is to assess the proportion of stroke patients that benefit from and have an earlier removal of the tracheotomy tube at the first attempt between 24 and 72 hrs after completion of the PES treatment as compared to patients who only get standard therapy.
 
The secondary objectives focus on the reduction of severity of dysphagia by the PES-treatment, the assessment of the difference in decannulation rate...
The primary objective of this prospective multicentre randomized double-blinded trial is to assess the proportion of stroke patients that benefit from and have an earlier removal of the tracheotomy tube at the first attempt between 24 and 72 hrs after completion of the PES treatment as compared to patients who only get standard therapy.
 
The secondary objectives focus on the reduction of severity of dysphagia by the PES-treatment, the assessment of the difference in decannulation rate between an EARLY and approximately a 5-days later (LATE) PES-treatment, the assessment of the success rate of decannulation after a second PES-treatment in patients where decannulation was not possible after a first PES-treatment, the assessment of decannulation success rates in similar patients not undergoing an EARLY PES-treatment, the assessment of the severity level of the stroke, the number of days a patient resides on the ICU, the occurrence of AE’s, including occurrence of pneumonia and the need to recannulate a patient over a time period of 30-days or until hospital discharge, whatever occurs first.
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