NCT07363902

Evaluation of heepSync, a Novel Algorithm for Transcutaneous Electrical Stimulation of Respiratory Muscles in Mechanically Ventilated Patients.

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.

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (estimated)
• Sponsor: Tesai Care SL · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Ventilator-induced Diaphragm Dysfunction
• VIDD
• Weaning Failure

Interventions

Type	Name	Description
DEVICE	Heecap	Transcutaneous Electrical Stimulation of Respiratory Muscles

Timeline

• Start date: 2024-12-01
• Primary completion: 2026-03-01
• Completion: 2026-05-01
• First posted: 2026-01-23
• Last updated: 2026-01-23

Locations

3 sites across 1 country: Spain