Status:
TERMINATED
Electromagnetic Stimulation of the Phrenic Nerve in Critically Ill Mechanically Ventilated Patients (STIMIT-II)
Lead Sponsor:
Charite University, Berlin, Germany
Collaborating Sponsors:
Stimit AG
Conditions:
Muscle Weakness
Critical Illness
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
Ventilator-induced diaphragmatic dysfunction is a common issue in critically ill patients. Muscle stimulation has shown to have beneficial effects in muscle groups on the extremities. A non-invasive w...
Detailed Description
During the time of first spontaneous breathing trial 60% of mechanically ventilated patients present with diaphragmatic weakness or also know as ventilator-induced diaphragmatic dysfunction (VIDD). Th...
Eligibility Criteria
Inclusion
- Patients between 18 and 60 years old, hospitalized in ICU
- Mechanical ventilation \< 36 h
- Prone to stay ventilated \> 72 h
Exclusion
- Known neurological condition affecting motor neuron or muscle (e.g. ALS)
- Known paralysis of the phrenic nerve
- Proven or suspected spinal cord injury that contraindicates weight bearing on the spinal cord
- Conditions that limit diaphragm movement (high intra-abdominal pressure, ascites, obesity)
- Not able to read and understand the national language German
- Patients with Implanted cardiac support systems (pacemaker, implanted defibrillator)
- Patients with implanted medical pumps
- Pregnant patients
- Patients with skin lesions, infections or strictures in throat/neck area
- Patients with metallic implants
Key Trial Info
Start Date :
January 21 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 15 2022
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT05238753
Start Date
January 21 2022
End Date
May 15 2022
Last Update
September 15 2022
Active Locations (1)
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1
Charité - Univiversitätsmedizin Berlin
Berlin, Germany, 10117