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

Sponsor: Tesai Care SL • ClinicalTrials.gov ID: NCT07363902

Registry updated: 2026-09-21

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Description

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.

Interventions

Heecap (Device)
Transcutaneous Electrical Stimulation of Respiratory Muscles

Eligibility 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.

Conditions

Ventilator-induced Diaphragm Dysfunction VIDD Weaning Failure

Locations

Hospital Universitari de Vall d'Hebrón — Barcelona, Barcelona, Spain
Hospital Universitari de Bellvitge — L'Hospitalet de Llobregat, Barcelona, Spain
Hospital Universitari Parc Tauli — Sabadell, Barcelona, Spain

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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