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New treatment option for Ventilator-induced Diaphragm Dysfunction
Official title Evaluation of heepSync, a Novel Algorithm for Transcutaneous Electrical Stimulation of Respiratory Muscles in Mechanically Ventilated Patients.
ClinicalTrials.gov ID: NCT07363902
What this study is testing
- What it's testing
- 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.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patient population 1
- Adult patients with acute hypoxemic respiratory failure who have been under controlled mechanical ventilation for at least 24 hours prior to...
- 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...
- Adult patients with acute hypoxemic respiratory failure who have been under pressure support mechanical ventilation for at least 24 hours prior to...
- 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...
You likely can't join if
- 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...
- BMI \> 40 kg/m2
- Hemodynamically unstable (noradrenaline \>0.1 microgram/kg/min)
See the full eligibility 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Barcelona, Barcelona, Spain
- L'Hospitalet de Llobregat, Barcelona, Spain
- Sabadell, Barcelona, Spain
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Barcelona, Barcelona, Spain; L'Hospitalet de Llobregat, Barcelona, Spain; Sabadell, Barcelona, Spain. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.