Evaluating the effects of light and magnetic therapy in patients on mechanical ventilation

Effects of Photobiomodulation Therapy Combined With Static Magnetic Field in Reducing the Number of Days in the Intensive Care Unit (ICU) for Adult Patients Requiring Mechanical Ventilation

This study is testing whether a combination of light and magnetic therapy can help adults on mechanical ventilation recover faster and improve their breathing muscle strength compared to a placebo treatment.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 112 (estimated)
• Ages: 21 Years and up
• Sex: All
• Sponsor: University of Nove de Julho (Academic / other)
• Locations: 1 site (Porto Alegre, Rio Grande do Sul)
• Trial ID: NCT06454006 on ClinicalTrials.gov

What this trial studies

This clinical trial aims to assess the effectiveness of photobiomodulation therapy combined with static magnetic field (PBMT-sMF) in adult patients requiring mechanical ventilation. It will compare the outcomes of patients receiving active PBMT-sMF alongside standard care to those receiving a placebo treatment. The primary objectives include determining if PBMT-sMF can reduce the length of ICU stay and increase diaphragm thickness in these patients. The study will be conducted as a multi-center, randomized, triple-blinded, placebo-controlled trial involving 112 participants.

Who should consider this trial

Good fit: Ideal candidates are adults aged 21 and older who are on mechanical ventilation for no more than 72 hours and are expected to remain on it for at least 48 hours.

Not a fit: Patients who have been on mechanical ventilation for longer than 72 hours or have a BMI over 40 kg/m² may not benefit from this study.

Why it matters

Potential benefit: If successful, this therapy could significantly reduce ICU stay and improve respiratory muscle function in mechanically ventilated patients.

How similar studies have performed: While the approach of combining photobiomodulation with static magnetic fields is innovative, similar studies have shown promise in improving outcomes in mechanically ventilated patients.

Eligibility criteria

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.

Where this trial is running

Porto Alegre, Rio Grande do Sul

• Santa Casa de Misericórdia de Porto Alegre — Porto Alegre, Rio Grande do Sul, Brazil (Recruiting)

Study contacts

• Principal investigator: Ernesto Leal Junior, PhD — University of Nove de Julho
• Study coordinator: Ernesto Leal Junior, PhD

Conditions Respiratory Failure; Mechanical ventilation; Photobiomodulation therapy; LLLT; Static magnetic field; Diaphragm; Intensive care unit