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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Mechanical ventilated patients in ICU | Experimental | Single arm for device-treated patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Heecap | Device | Transcutaneous Electrical Stimulation of Respiratory Muscles |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of AEs/SAEs | Number of Serious adverse events and Adverse events. Those will be collected and analyzed. | through study completion (up to 4 days) |
| Transdiaphragmatic pressure (PDi) | 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) |
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Inclusion Criteria:
Patient population 1
Patient population 2
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Barbara Flix, PhD | Contact | +34933946511 | barbara@heecap.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitari de Vall d'Hebrón | Recruiting | Barcelona | Barcelona | 08035 | Spain | |
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Multicenter Single Arm Pilot Trial
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| During TERM on day 1 and day 2 |
| Muscle thickening fraccion | 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) | Day 1 and day 2 of treatment |
| Occlusion pressure (Pocc) | Differences of Pocc mesured after stimulation sessions on day 1 and 2 and compared to basal (previous to stimulation session on day 1) | Day 1 and day 2 |
| Hospital Universitari de Bellvitge |
| Recruiting |
| L'Hospitalet de Llobregat |
| Barcelona |
| 08907 |
| Spain |
| Hospital Universitari Parc Tauli | Recruiting | Sabadell | Barcelona | 08208 | Spain |