Evaluation of heepSync, a Novel Algorithm for Transcutaneous Electrical Stimulation of Respiratory Muscles in Mechanically Ventilated Patients.
Recruiting
N/A
Interventional Study
Ventilator-induced Diaphragm Dysfunction
VIDD
Weaning Failure
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Study type
- Interventional
- Purpose
- Device Feasibility
- Participants needed
- 20 (estimated)
- Sponsor
- Tesai Care SL · Industry
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About This Trial
Up to 76% of ICU patients on mechanical ventilation develop significant respiratory muscle atrophy within the first 24 hours, contributing to prolonged ventilation, increased morbidity, and higher healthcare costs. To date, there is no practical, non-invasive technology that offers synchronized, personalized electrostimulation for both inspiratory and expiratory muscles during mechanical ventilati…
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
Patient population 1
* Adult patients with acute hypoxemic respiratory failure who have been under controlled mechanical ventilation for at least 24 hours prior to enrollment.
* Clinically stable: oxygen saturation \> 90% with a fractional inspired oxygen ≤ 0.50, eternal PEEP ≤…
Contacts