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

Tesai Care SL

Status: Enrolling

Conditions: Weaning Failure; VIDD; Ventilator-induced Diaphragm Dysfunction

Treatments: Device: Heecap

Study type: Interventional

Funder types: Industry

Identifiers

NCT07363902

Heecap I

Details and patient eligibility

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.

Enrollment: 20 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Mechanical ventilated patients in ICU

Experimental group

Description:

Single arm for device-treated patients

Treatment:

Device: Heecap