Status:
UNKNOWN
PES to Avoid Extubation Failure in Intubated Stroke Patients at High Risk of Severe Dysphagia
Lead Sponsor:
University Hospital Muenster
Conditions:
Stroke
Dysphagia
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Post-extubation dysphagia (PED) recently became a growing concern as a major risk factor for extubation failure and significant contributor to poor patient outcomes with prevalence rates ranging from ...
Detailed Description
Endotracheal intubation and mechanical ventilation are common procedures for critically ill stroke patients. Although necessary and life-saving, timely extubation after ventilator weaning is desirable...
Eligibility Criteria
Inclusion
- Acute stroke orotracheal intubation high-risk of extubation failure (DEFISS-score ≥4) successful respiratory weaning according to the treating intensivist within 24 to 72 hours
Exclusion
- Patients are excluded from study participation if any of the following apply:
- Suffer from pre-existing neurogenic dysphagia or a condition that can cause dysphagia (for example Parkinson's Disease);
- Suffer from non-neurogenic dysphagia (e.g. cancer);
- Suffer from neuromuscular disorders (e.g. myasthenia gravis, motor neuron disease);
- Participate in any other study potentially influencing the outcome of PES, both medicinal or medical device product related and for which the patient signed a consent form for his/her study participation;
- Receive or have received within one month prior to the intended PES treatment any other type of standard cranial or percutaneous electrical stimulation therapy to treat dysphagia;
- Have a pacemaker or an implantable defibrillator;
- Have a nasal anatomical deformity, nasal airway obstruction, have had oesophageal surgery or any other circumstance where placement of a standard NG feeding tube would be deemed unsafe;
- Have a cardiac or respiratory condition that might render the insertion of the catheter into the throat unsafe;
- Are pregnant or nursing women;
Key Trial Info
Start Date :
July 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2019
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT04010617
Start Date
July 1 2018
End Date
December 31 2019
Last Update
July 8 2019
Active Locations (1)
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1
University Hospital Münster, Deparment of Neurology
Münster, Germany, 48149