Effects of PBMT-sMF in Mechanically Ventilated Patients

NCT06454006 | Recruiting FDA Device

• 1 other identifier: 6.738.501
• Study Type: interventional
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

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? (ii) Does PBMT-sMF increase the diaphragm thickness in mechanically ventilated patients in the ICU? Researches will compare active PBMT-sMF plus standard of care to a placebo PBMT-sMF plus standard of care to see if active PBMT-sMF works to prevent or retard disuse atrophy of the diaphragm during mechanical ventilation.

Conditions

Respiratory Failure

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Length of stay in the intensive care unit (ICU)

  Number of days hospitalized in the ICU until discharge from ICU.

  From date of ICU admission until the date of discharge of the ICU.

Secondary Outcomes (21)

• Length of stay in the hospital

  Assessments once every two weeks after discharge from ICU until the date of discharge of hospital or date of death from any cause, whichever came first, up to 2 years.

• Length of time until weaning from mechanical ventilation (MV)

  After 14 days of treatment; after 28 days of treatment; and once every two weeks until the date of successful weaning from MV or date of death, whichever came first, up to 2 years.

• Levels of positive end-expiratory pressure levels (PEEP)

  After 14 days of treatment; after 28 days of treatment; and once every two weeks until the date of successful weaning from MV or date of death, whichever came first, up to 2 years.

• Levels of fraction of inspired oxygen (FiO2)

  After 14 days of treatment; after 28 days of treatment; and once every two weeks until the date of successful weaning from MV or date of death, whichever came first, up to 2 years.

• Arterial partial pressure of oxygen (PO2)

  After completion of 14 days of treatment; after completion of 28 days of treatment, and assessments once every two weeks until the date of successful weaning from mechanical ventilation or date of death, whichever came first, up to 2 years.

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo treatment will be delivered using Multi Radiance® Medical PhotOxyl photoceutical medical device emitting a light source that is sufficient to be indistinguishable from the active comparator but does not deliver any therapeutic energy, combined with standard of care therapy for a mechanically ventilated patient in the ICU. The treatment administration protocol comprises one 7-minute treatment administration per day on each consecutive day for four consecutive weeks, for a maximum of 28 consecutive treatments over 28 consecutive days, or until the day of the subject's successful weaning from mechanical ventilation, or until the day of the subject's death, whichever occurs first.

Device: Placebo PBMT-sMF

Active

ACTIVE COMPARATOR

Active treatment will be delivered using Multi Radiance® Medical PhotOxyl photoceutical medical device in active mode, combined with standard of care therapy for a mechanically ventilated patient in the ICU. The treatment administration protocol comprises one 7-minute treatment administration per day on each consecutive day for four consecutive weeks, for a maximum of 28 consecutive treatments over 28 consecutive days, or until the day of the subject's successful weaning from mechanical ventilation, or until the day of the subject's death, whichever occurs first.

Device: Active PBMT-sMF

Interventions

Placebo PBMT-sMF DEVICE

Placebo, without therapeutic dose.

Placebo

Active PBMT-sMF DEVICE

Active with a dose of 31.50 J per site.

Active

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify 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 through orotracheal intubation;
• Predicted to remain on mechanical ventilation for at least 48 hours (≥48 hours) from the time of study enrollment

You may not qualify 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;
• 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;

Sponsors & Collaborators

• University of Nove de Julho: lead
• Multi Radiance Medical: collaborator

Study Sites (1)

Santa Casa de Misericórdia de Porto Alegre

Porto Alegre, Rio Grande do Sul, 90035-074, Brazil

RECRUITING

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Ernesto Leal Junior, PhD

  University of Nove de Julho

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ernesto Leal Junior, PhD

CONTACT

+551133859134; ernesto.leal.junior@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: A researcher will program the device (placebo or active) and will be instructed not to inform the patients, therapists or other researchers as to the type of treatment (placebo or active). Therefore, the patients, therapists, and the outcome assessors will be blinded to the type of treatment being administered to the patients. The sounds and signals emitted from the device as well as the information displayed on the screen will be identical, regardless of the type of treatment (placebo or active).
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full professor

Study Record Dates

• First Submitted: May 28, 2024
• First Posted: June 12, 2024
• Study Start: July 31, 2024
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): June 1, 2027
• Last Updated: April 23, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The data will become available during five years after the study completion.
• Access Criteria: All IPD that underlie results in a publication will be available on reasonable request.

Locations

BR (1)