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

NCT07363902 | Recruiting

• 1 other identifier: Heecap I
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Ventilator-induced Diaphragm Dysfunction; VIDD; Weaning Failure

Keywords

Transcutaneous Electrical Stimulation; Mechanical ventilation; respiratory muscles

Outcome Measures

Primary Outcomes (1)

• Device synchronization success rate

  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.

  through study treatment phase completion (up to 3 days)

Secondary Outcomes (4)

• Incidence of AEs/SAEs

  through study completion (up to 4 days)

• Transdiaphragmatic pressure (PDi)

  During TERM on day 1 and day 2

• Muscle thickening fraccion

  Day 1 and day 2 of treatment

• Occlusion pressure (Pocc)

  Day 1 and day 2

Study Arms (1)

Mechanical ventilated patients in ICU

EXPERIMENTAL

Single arm for device-treated patients

Device: Heecap

Interventions

Heecap DEVICE

Transcutaneous Electrical Stimulation of Respiratory Muscles

Mechanical ventilated patients in ICU

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tesai Care SL: lead

Study Sites (3)

Hospital Universitari de Vall d'Hebrón

Barcelona, Barcelona, 08035, Spain

RECRUITING

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

RECRUITING

Hospital Universitari Parc Tauli

Sabadell, Barcelona, 08208, Spain

RECRUITING

Central Study Contacts

Barbara Flix, PhD

CONTACT

+34933946511; barbara@heecap.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multicenter Single Arm Pilot Trial

Study Record Dates

• First Submitted: December 17, 2025
• First Posted: January 23, 2026
• Study Start: December 1, 2024
• Primary Completion: March 1, 2026
• Study Completion: May 1, 2026
• Last Updated: January 23, 2026

Record last verified: 2026-01

Locations

ES (3)