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. A subset of patients (n=5), will participate in a substudy to test safety and feasibility of the multifield electrodes heepStim compared to conventional electrodes.
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 ≤ 10 cm H2O, temperature ranging from 35.5 to 38.5 ºC, no intravenous administration of vasoactive agents.
Adult patients with acute hypoxemic respiratory failure who have been under pressure support mechanical ventilation for at least 24 hours prior to enrollment.
Clinically stable: oxygen saturation > 90% with a fractional inspired oxygen ≤ 0.50, eternal PEEP ≤ 10 cm H2O, temperature ranging from 35.5 to 38.5 ºC, no intravenous administration of vasoactive agents.
Patients treated with neuromuscular blocking agents
Patients with neuromuscular disease
Patients with a pacemaker or past history of arrhythmia
Patients with physical obstacles that prevent thoracic or abdominal electrostimulation (e.g., abdominal trauma, recent abdominal surgery, polytrauma, broken or irritated skin)
Single group
Heecap
DeviceTranscutaneous Electrical Stimulation of Respiratory Muscles
Device 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.
Incidence of AEs/SAEs
Number of Serious adverse events and Adverse events. Those will be collected and analyzed.
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)
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)
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)
Safety and preliminary performance of heepStim multifield electrodes substudy
A substudy will be performed to explore safety and preliminary performance of heepStim multifield electrodes in comparison with conventional electrodes, measuring safety parameters as skin reaction and adverse events, and performance parameters, as intensity required for optimal contraction, feasibility of successful electrode placement and time required for proper area selection for stimulation. 5 subjects will be treated with conventional eletrodes on day 1 and multifield electrodes on day 2 and 3.
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