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Clinical Trials in Spain / NCT07363902
Recruiting Not applicable

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

NCT07363902 · tracked via the Priya Life Science Spain tracker
Sponsor
Tesai Care SL
Phase
Not applicable
Started
2024-12-01
Last updated
2026-09-21

Condition(s) studied

Ventilator-induced Diaphragm DysfunctionVIDDWeaning Failure

Investigational drug(s) / intervention(s)

Heecap

Heecap: Transcutaneous Electrical Stimulation of Respiratory Muscles

Study 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. 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Device synchronization success rate — 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.

Trial sites (3)

FacilityCityRegionStatus
Hospital Universitari de Vall d'Hebrón Barcelona Barcelona Recruiting
Hospital Universitari de Bellvitge L'Hospitalet de Llobregat Barcelona Recruiting
Hospital Universitari Parc Tauli Sabadell Barcelona Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07363902 on ClinicalTrials.gov ↗ ← All trials in Spain