Condition: Ventilator-induced Diaphragm Dysfunction · VIDD · Weaning Failure · Sponsor: Tesai Care SL
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 ventilation. Heecap is a medical product designed to provide transcutaneous electrical stimulation of the respiratory muscles (TERM) that are involved in inspiration and expiration, detecting those in which it is clinically relevant and safe to provide such stimulation in assisted respiration. The following study aims to evaluate the safety and preliminary performance of the stimulation algorithm in mechanically ventilated patients in the ICU. This evaluation will specifically focus on the algorithm's ability to synchronize stimulation with the patient's breathing patterns, and on evaluating the safety and feasibility of the TERM in activating respiratory muscles.
This description comes directly from the study's public registry record.
Barbara Flix, PhD · +34933946511 · barbara@heecap.com
Always discuss trial participation with your own doctor first.
| Hospital Universitari de Vall d'Hebrón | Barcelona, Barcelona, Spain | Recruiting |
| Hospital Universitari de Bellvitge | L'Hospitalet de Llobregat, Barcelona, Spain | Recruiting |
| Hospital Universitari Parc Tauli | Sabadell, Barcelona, Spain | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07363902