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NCT Number: NCT07363902

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Universitari de Vall d'Hebrón, Barcelona, Spain

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Heecap

Device

Transcutaneous Electrical Stimulation of Respiratory Muscles

Primary outcomes

  1. Device synchronization success rate

    Time frame: 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.

Secondary outcomes

  1. Incidence of AEs/SAEs

    Time frame: through study completion (up to 4 days)

    Number of Serious adverse events and Adverse events. Those will be collected and analyzed.

  2. Transdiaphragmatic pressure (PDi)

    Time frame: During TERM on day 1 and day 2

    Comparison of PDi during stimulation session at day 1, stimulation session at day 2 and compared to basal (non stimulated, previous to session on day 1)

  3. Muscle thickening fraccion

    Time frame: Day 1 and day 2 of treatment

    Difference of muscle thickening fraction in inspiration muscles and expiration muscles during stimulation (TERM sessions on day 1 and day 2) and compared to basal (pre-stimulation day 1)

  4. Occlusion pressure (Pocc)

    Time frame: Day 1 and day 2

    Differences of Pocc mesured after stimulation sessions on day 1 and 2 and compared to basal (previous to stimulation session on day 1)

Study contacts

Contact information is provided by the study sponsor or research team.

Barbara Flix, PhD

CONTACT

[email protected]

+34933946511

Sponsors and collaborators

Lead sponsor

Tesai Care SL

Industry

Registry information

Official study title

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.

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 23, 2026
Registry last updated
Jan 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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