heepSync: synchronized electrical stimulation of breathing muscles for adults on mechanical ventilation
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.
This trial tests whether the heecap heepSync algorithm can safely sync electrical stimulation to breathing muscles in adults on mechanical ventilation.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Tesai Care SL Industry-sponsored |
| Locations | 3 sites (Barcelona, Barcelona and 2 other locations) |
| Trial ID | NCT07363902 on ClinicalTrials.gov |
What this trial studies
Heecap's heepSync algorithm delivers transcutaneous electrical stimulation to inspiratory and expiratory respiratory muscles and attempts to synchronize that stimulation with the patient's own breathing while they remain on mechanical ventilation. The trial enrolls clinically stable adult ICU patients with acute hypoxemic respiratory failure who have been on controlled or pressure-support ventilation for at least 24 hours. Investigators will apply the device at the bedside and monitor synchronization performance, physiologic responses, and safety outcomes including arrhythmia, hemodynamic changes, and tolerance. The primary focus is on preliminary safety and the algorithm's ability to detect and time stimulation to patient breaths.
Who should consider this trial
Good fit: Adults in the ICU with acute hypoxemic respiratory failure who have been on controlled or pressure-support mechanical ventilation for ≥24 hours, are clinically stable (SpO2 > 90% on FiO2 ≤ 0.50, PEEP ≤ 10 cm H2O, temperature 35.5–38.5°C), and are not receiving vasoactive drugs or neuromuscular blockers and have no exclusionary conditions such as pacemaker or neuromuscular disease.
Not a fit: Patients with pacemakers or a history of arrhythmia, neuromuscular disease, ongoing neuromuscular blockade, hemodynamic instability, high oxygen/PEEP requirements, or physical barriers to electrode placement are unlikely to be eligible or to benefit from this device.
Why it matters
Potential benefit: If successful, this approach could help preserve respiratory muscle strength and shorten the time patients need mechanical ventilation.
How similar studies have performed: Transcutaneous synchronized stimulation of both inspiratory and expiratory muscles in ventilated patients is largely novel; while some invasive diaphragm or phrenic stimulation approaches have limited supporting data, evidence for this noninvasive algorithmic method is preliminary.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: Patient population 1 * 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. Patient population 2 * 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. Exclusion Criteria: * 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) * BMI \> 40 kg/m2 * Hemodynamically unstable (noradrenaline \>0.1 microgram/kg/min) * Pregnancy * Patients under the age of 18 * The formalized ethical decision to withhold or withdraw life support * Patient under guardianship * Patients deprived of liberties * Patients already enrolled in the present study, in a previous episode of acute respiratory failure. * The patient who does not consent.
Where this trial is running
Barcelona, Barcelona and 2 other locations
- 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)
Study contacts
- Study coordinator: Barbara Flix, PhD
- Email: barbara@heecap.com
- Phone: +34933946511
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.