Light and magnets may shorten ICU stays for ventilator patients
NCT ID NCT06454006
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests a device that uses light and a static magnetic field (PBMT-sMF) on adult ICU patients who need a breathing machine. The goal is to see if this therapy can reduce the number of days in the ICU and prevent diaphragm muscle weakness. Researchers will compare the active device to a placebo, both added to standard care, in 112 participants.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- photobiomodulation therapy combined with static magnetic field (PBMT-sMF) device
- What this could lead to
- If it works, this could shorten ICU stays and reduce diaphragm muscle wasting for patients on breathing machines.
- What could go wrong
- This is an early-stage, small trial (112 people) testing a device, so results may not be conclusive or widely applicable. The therapy is experimental and may not provide benefit over standard care.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 112 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2024
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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21 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Legally authorized representative signed informed consent; * Male or female aged 21 years or older; * On mechanical ventilation through orotracheal intubation for no more than 72 hours prior to study enrollment or pending mechanical ventilation through orotracheal intubation; * Predicted to remain on mechanical ventilation for at least 48 hours (≥48 hours) from the time of study enrollment Exclusion Criteria: * Mechanical ventilation initiated longer than 72 hours prior to anticipated enrollment; * Body Mass Index (BMI) \> 40 kg/m²; * Fever of 100.4°C or higher; * Situated in the prone position for 24 hours or longer during mechanical ventilation; * Prognosis of mortality within 72 hours, per the patient's physician; * Hypersensitivity to light; * Use of non-invasive ventilation, Continuous Positive Airway Pressure (CPAP) and/or Bilevel Positive Airway Pressure (BiPAP) device for ≥ 50% of the time over the preceding 6 months; * Tracheostomy; * Any one or more of the following present on both sides of the neck (bilaterally) at the intended treatment site(s): internal jugular (IJ) venous cannulation; incisions, significant bruising; burn(s); notable skin irritation/rash, or other skin condition that may place the subject at risk from harm from the device treatment; * Fracture, external or internal hemorrhage, or at risk of hemorrhage following acute trauma or fracture, or known or potential acute occult bleeding (e.g., gastric ulcer, intestine) in the intended treatment areas; * Metallic device implants or body penetrating metallic devices in the upper body/neck area whose location may interfere with the study device treatment administration. E.g., extracorporeal membrane oxygenation (ECMO) cannula; * Non-removable electrical/electronic device in the upper body/neck area that may interfere with the study device treatment administration, e.g., -implanted pacemaker or cardiac defibrillator; * Cardiogenic or septic shock with ongoing severe hemodynamic instability (according to the American College of Chest Physicians definition (that cannot be stabilized within the 48 hours enrollment period); * Conditions that may limit ultrasonographic assessment of diaphragmatic thickness, e.g., occluding chest drain, pleural effusion, pulmonary consolidation of the lower lobe(s); * Current cancer of any type; * Pregnancy; * Any comorbidity, co-existing condition or illness, or other factor that in the opinion of the study investigator may render the subject unsuitable for participation in the study; * Admission to the ICU within the last 12 months due to respiratory distress/failure; * Two or more admissions to the ICU within the prior 12 months for any reason; * Current participation in another clinical study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Santa Casa de Misericórdia de Porto Alegre
RECRUITINGPorto Alegre, Rio Grande do Sul, 90035-074, Brazil
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