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New treatment option for Respiratory Failure
Official title Effects of PBMT-sMF in Mechanically Ventilated Patients
ClinicalTrials.gov ID: NCT06454006
What this study is testing
- What it's testing
- The goal of this clinical trial is to evaluate the effectiveness of photobiomodulation therapy combined with static magnetic field (PBMT-sMF) in adult patients who require mechanical ventilation. The main questions it aims to answer are: (i) Does PBMT-sMF lower the length of stay in the intensive care unit (ICU) for mechanically ventilated patients?
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 and older
You may be able to join if
- 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...
- Predicted to remain on mechanical ventilation for at least 48 hours (≥48 hours) from the time of study enrollment
You likely can't join if
- 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;
See the full eligibility 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
- 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...
- 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)...
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Porto Alegre, Rio Grande do Sul, Brazil
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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, 21 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Porto Alegre, Rio Grande do Sul, Brazil. 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.