Utvärdering av heepSync, en ny algoritm för transkutan elektrisk stimulering av andningsmuskler hos mekaniskt ventilerade patienter.
Klinisk säkerhets- och genomförbarhetsstudie för icke CE-märkt medicinteknisk produkt: Utvärdering av heepSync, en ny algoritm för transkutan elektrisk stimulering av andningsmuskulatur hos mekaniskt ventilerade patienter.
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. A subset of patients (n=5), will participate in a substudy to test safety and feasibility of the multifield electrodes heepStim compared to conventional electrodes.
Studieöversikt
Status
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Inte tillämpbar
Kontakter och platser
Studiekontakt
- Namn: Barbara Flix, PhD
- Telefonnummer: +34933946511
- E-post: barbara@heecap.com
Studieorter
-
-
Barcelona
-
Barcelona, Barcelona, Spanien, 08035
- Rekrytering
- Hospital Universitari de Vall d'Hebrón
-
L'Hospitalet de Llobregat, Barcelona, Spanien, 08907
- Rekrytering
- Hospital Universitari de Bellvitge
-
Sabadell, Barcelona, Spanien, 08208
- Rekrytering
- Hospital Universitari Parc Tauli
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Enhetens genomförbarhet
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
|
Experimentell: Mechanical ventilated patients in ICU
Single arm for device-treated patients |
Transcutaneous Electrical Stimulation of Respiratory Muscles |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Device synchronization success rate
Tidsram: 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. |
through study treatment phase completion (up to 3 days)
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Incidence of AEs/SAEs
Tidsram: through study completion (up to 4 days)
|
Number of Serious adverse events and Adverse events. Those will be collected and analyzed. |
through study completion (up to 4 days)
|
|
Transdiaphragmatic pressure (PDi)
Tidsram: 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) |
During TERM on day 1 and day 2
|
|
Muscle thickening fraccion
Tidsram: 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) |
Day 1 and day 2 of treatment
|
|
Occlusion pressure (Pocc)
Tidsram: 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) |
Day 1 and day 2
|
Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Safety and preliminary performance of heepStim multifield electrodes substudy
Tidsram: day 1 vs day 2 and 3
|
A substudy will be performed to explore safety and preliminary performance of heepStim multifield electrodes in comparison with conventional electrodes, measuring safety parameters as skin reaction and adverse events, and performance parameters, as intensity required for optimal contraction, feasibility of successful electrode placement and time required for proper area selection for stimulation. 5 subjects will be treated with conventional eletrodes on day 1 and multifield electrodes on day 2 and 3. |
day 1 vs day 2 and 3
|
Samarbetspartners och utredare
Sponsor
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Beräknad)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Andra studie-ID-nummer
- Heecap I
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
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