Ventilator-induced Diaphragm Dysfunction, VIDD, Weaning Failure
Conditions
Keywords
Transcutaneous Electrical Stimulation, Mechanical ventilation, respiratory muscles
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.
Interventions
DEVICEHeecap
Transcutaneous Electrical Stimulation of Respiratory Muscles
Sponsors
Tesai Care SL
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DEVICE_FEASIBILITY
Masking
NONE
Intervention model description
Multicenter Single Arm Pilot Trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Device synchronization success rate | through study treatment phase completion (up to 3 days) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of AEs/SAEs | through study completion (up to 4 days) | Number of Serious adverse events and Adverse events. Those will be collected and analyzed. |
| Transdiaphragmatic pressure (PDi) | During TERM on day 1 and day 2 | 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) |
| Muscle thickening fraccion | Day 1 and day 2 of treatment | 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) |
| Occlusion pressure (Pocc) | Day 1 and day 2 | Differences of Pocc mesured after stimulation sessions on day 1 and 2 and compared to basal (previous to stimulation session on day 1) |
Countries
Spain
Contacts
CONTACTBarbara Flix, PhD
Outcome results
None listed