heepSync: synchronized electrical stimulation of breathing muscles for adults on mechanical ventilation

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Heecap's heepSync algorithm delivers transcutaneous electrical stimulation to inspiratory and expiratory respiratory muscles and attempts to synchronize that stimulation with the patient's own breathing while they remain on mechanical ventilation. The trial enrolls clinically stable adult ICU patients with acute hypoxemic respiratory failure who have been on controlled or pressure-support ventilation for at least 24 hours. Investigators will apply the device at the bedside and monitor synchronization performance, physiologic responses, and safety outcomes including arrhythmia, hemodynamic changes, and tolerance. The primary focus is on preliminary safety and the algorithm's ability to detect and time stimulation to patient breaths.

Why it matters

Who can join: the full rules

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.

Where it's running

• Hospital Universitari de Vall d'Hebrón
  Barcelona, Barcelona, Spain Recruiting
• Hospital Universitari de Bellvitge
  L'Hospitalet de Llobregat, Barcelona, Spain Recruiting
• Hospital Universitari Parc Tauli
  Sabadell, Barcelona, Spain Recruiting

Study contacts

• Study coordinator: Barbara Flix, PhD
• Email: barbara@heecap.com
• Phone: +34933946511

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.