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Recruiting NCT07363902

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

No phase Interventional Ventilator-induced Diaphragm Dysfunction VIDD Weaning Failure

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Heecap.
Who it may be relevant to
Registry conditions: Ventilator-induced Diaphragm Dysfunction, VIDD, Weaning Failure. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Spain
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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.

Overview

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.

Interventions

  • Device Heecap
    Transcutaneous Electrical Stimulation of Respiratory Muscles

Primary outcome measures

  • Device synchronization success rate [Time frame: through study treatment phase completion (up to 3 days)]
Secondary outcome measures (4)
  • Incidence of AEs/SAEs [Time frame: through study completion (up to 4 days)]
  • Transdiaphragmatic pressure (PDi) [Time frame: During TERM on day 1 and day 2]
  • Muscle thickening fraccion [Time frame: Day 1 and day 2 of treatment]
  • Occlusion pressure (Pocc) [Time frame: Day 1 and day 2]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Device feasibility

Study locations

Spain · 3 centers
  • Hospital Universitari de Vall d'Hebrón — Barcelona
  • Hospital Universitari de Bellvitge — L'Hospitalet de Llobregat
  • Hospital Universitari Parc Tauli — Sabadell

Identifiers

NCT: NCT07363902 · Heecap I

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗