Actively Recruiting
Evaluation of heepSync, a Novel Algorithm for Transcutaneous Electrical Stimulation of Respiratory Muscles in Mechanically Ventilated Patients.
Led by Tesai Care SL · Updated on 2026-01-23
20
Participants Needed
3
Research Sites
73 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Evaluation of heepSync, a Novel Algorithm for Transcutaneous Electrical Stimulation of Respiratory Muscles in Mechanically Ventilated Patients.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patients with acute hypoxemic respiratory failure who have been under controlled mechanical ventilation for at least 24 hours prior to enrollment.
- Clinically stable with oxygen saturation > 90% on fractional inspired oxygen 0.50, external PEEP 10 cm H2O, temperature between 35.5 and 38.5 aC, and no intravenous vasoactive agents.
- 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 with oxygen saturation > 90% on fractional inspired oxygen 0.50, external PEEP 10 cm H2O, temperature between 35.5 and 38.5 aC, and no intravenous vasoactive agents.
You will not qualify if you...
- Patients treated with neuromuscular blocking agents.
- Patients with neuromuscular disease.
- Patients with a pacemaker or history of arrhythmia.
- Patients with physical obstacles preventing thoracic or abdominal electrostimulation such as abdominal trauma, recent abdominal surgery, polytrauma, or broken/irritated skin.
- Body mass index greater than 40 kg/m2.
- Hemodynamically unstable patients (noradrenaline > 0.1 microgram/kg/min).
- Pregnant patients.
- Patients under 18 years old.
- Patients with formal ethical decisions to withhold or withdraw life support.
- Patients under guardianship.
- Patients deprived of liberties.
- Patients already enrolled in this study for a previous episode of acute respiratory failure.
- Patients who do not consent to participate.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Hospital Universitari de Vall d'Hebrón
Barcelona, Barcelona, Spain, 08035
Actively Recruiting
2
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain, 08907
Actively Recruiting
3
Hospital Universitari Parc Tauli
Sabadell, Barcelona, Spain, 08208
Actively Recruiting
Research Team
B
Barbara Flix, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
DEVICE_FEASIBILITY
Number of Arms
1
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