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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Enrollment
20
Transcutaneous Electrical Stimulation of Respiratory Muscles
Hospital Universitari de Vall d'Hebrón
Barcelona, Barcelona, Spain
RECRUITINGHospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
RECRUITINGHospital Universitari Parc Tauli
Sabadell, Barcelona, Spain
RECRUITINGDevice synchronization success rate
Device feasibility in correctly stimulating breaths measured by the % of correct stimulated breaths of total breaths stimulated. All stimulated breaths will be analyzed and categorized as correctly stimulated or incorrectly stimulated.
Time frame: through study treatment phase completion (up to 3 days)
Incidence of AEs/SAEs
Number of Serious adverse events and Adverse events. Those will be collected and analyzed.
Time frame: through study completion (up to 4 days)
Transdiaphragmatic pressure (PDi)
Comparison of PDi during stimulation session at day 1, stimulation session at day 2 and compared to basal (non stimulated, previous to session on day 1)
Time frame: During TERM on day 1 and day 2
Muscle thickening fraccion
Difference of muscle thickening fraction in inspiration muscles and expiration muscles during stimulation (TERM sessions on day 1 and day 2) and compared to basal (pre-stimulation day 1)
Time frame: Day 1 and day 2 of treatment
Occlusion pressure (Pocc)
Differences of Pocc mesured after stimulation sessions on day 1 and 2 and compared to basal (previous to stimulation session on day 1)
Time frame: Day 1 and day 2
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