Effects of Neuromuscular Electrical Stimulation on Critically Ill Patients With Mechanical Ventil… (NCT05217511) | Clinical Trial Compass
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Effects of Neuromuscular Electrical Stimulation on Critically Ill Patients With Mechanical Ventilation
China47 participantsStarted 2022-02-01
Plain-language summary
Up to 25% of patients who require mechanical ventilation (MV) more than seven days in the intensive care unit (ICU) develop muscle weakness, which comprises deep muscle weakness , including the respiratory muscles.Early active mobilization in ICU patients is a safe and viable strategy to prevent the physical problems caused by immobility. Neuromuscular electrical stimulation (NMES) is an alternative to mobilize and exercise because it does not require active patient participation and can be used on bedridden patients.No previous studies have shown whether training-specific respiratory muscles using an electrical stimulation can have overall benefits for ICU patients on MV.For this reason, the aim of this study was to evaluate, the effectiveness of the NMES therapy combined with early rehabilitation in the respiratory muscles of patients on MV.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Prolonged MV(\>72 h);
* Written informed consent was obtained from the patients or their relatives
Exclusion Criteria:
* Previous neuromuscular disease;
* Unrelieved pneumothorax, restricted diaphragmatic dyskinesia including abdominal high pressure, a large number of ascites
* Thoracic or diaphragmatic malformation;
* Local skin damage and infection;
* Indwelling a temporary or permanent pacemaker;
* Severe obesity(BMI\>35 kg/m2)
* Various reasons (severe intestinal gas accumulation, structural abnormalities) lead to the failure of ultrasonic detection of diaphragm movement;
* Patients with an expected survival time of less than 7 days or with palliative care
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
diaphragmatic thickening fraction(DTF)
Timeframe: baseline,Day 3 of mechanical ventilation,Day 7 of mechanical ventilation,before extubation
Trial details
NCT IDNCT05217511
SponsorThe Affiliated Hospital of Qingdao University