Heecap
DeviceTranscutaneous Electrical Stimulation of Respiratory Muscles
NCT Number: NCT07363902
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Hospital Universitari de Vall d'Hebrón, Barcelona, Spain
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Patient population 1
Patient population 2
Exclusion criteria
Transcutaneous Electrical Stimulation of Respiratory Muscles
Time frame: through study treatment phase completion (up to 3 days)
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 completion (up to 4 days)
Number of Serious adverse events and Adverse events. Those will be collected and analyzed.
Time frame: During TERM on day 1 and day 2
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: Day 1 and day 2 of treatment
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
Differences of Pocc mesured after stimulation sessions on day 1 and 2 and compared to basal (previous to stimulation session on day 1)
Contact information is provided by the study sponsor or research team.
Tesai Care SL
Industry
Clinical Safety and Feasibility Study for Non-CE Marked Medical Device: Evaluation of heepSync, a Novel Algorithm for Transcutaneous Electrical Stimulation of Respiratory Muscles in Mechanically Ventilated Patients.
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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