Actively Recruiting
Clinical Safety and Feasibility Study of heepSync for 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
8 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Up to 76% of patients in intensive care units (ICU) who are on mechanical ventilators develop significant weakening of their breathing muscles within the first 24 hours. This muscle loss can lead to longer ventilation times, more health problems, and higher medical costs. Researchers are studying a new medical device called Heecap that provides synchronized electrical stimulation to the muscles used for both breathing in and out during mechanical ventilation. The goal is to evaluate the safety and early performance of this stimulation algorithm in ICU patients who require assisted breathing. The study involves using the Heecap device, which delivers transcutaneous electrical stimulation to the respiratory muscles. This device detects when it is safe and relevant to stimulate these muscles in patients receiving assisted breathing. The study includes a single group of mechanically ventilated patients in the ICU who will receive this device-based treatment. The treatment phase lasts up to 3 days, during which the synchronization of the stimulation with the patient's breathing will be assessed. Participants will be monitored for their response to the device, including measurements of how well the stimulation synchronizes with breathing, muscle pressure, muscle thickness, and breathing effort on the first and second day of treatment. Safety will be tracked by recording any adverse events during the study period of up to 4 days. The total time a participant will be involved depends on the length of treatment and follow-up assessments. This study aims to understand both the feasibility and safety of this new stimulation method in critically ill patients.
CONDITIONS
Brief 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 under controlled mechanical ventilation for at least 24 hours before enrollment
- Adult patients with acute hypoxemic respiratory failure under pressure support mechanical ventilation for at least 24 hours before enrollment
- Clinically stable with oxygen saturation above 90% on fractional inspired oxygen of 0.50 or less
- PEEP (positive end-expiratory pressure) of 10 cm H2O or less
- Temperature between 35.5 and 38.5 degrees Celsius
- No intravenous use of vasoactive agents
You will not qualify if you...
- Treatment with neuromuscular blocking agents
- Neuromuscular disease
- Presence of a pacemaker or history of arrhythmia
- Physical conditions preventing thoracic or abdominal electrostimulation such as abdominal trauma or recent surgery
- Body mass index over 40 kg/m2
- Hemodynamic instability with noradrenaline dose over 0.1 microgram/kg/min
- Pregnancy
- Under 18 years of age
- Ethical decision to withhold or withdraw life support
- Under guardianship or deprived of liberties
- Previously enrolled in this study during a prior episode of acute respiratory failure
- Lack of consent to participate
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 days
Participants receive transcutaneous electrical stimulation of respiratory muscles using the heepSync device while mechanically ventilated in the ICU.
Daily assessments during treatment
Duration - Up to 1 day
Participants are monitored for safety and device performance after completion of device treatment.
1 visit (in-person)
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
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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