Actively Recruiting

Phase Not Applicable
Age: 21Years +
All Genders
NCT06454006

Effects of PBMT-sMF in Mechanically Ventilated Patients

Led by University of Nove de Julho · Updated on 2026-04-23

112

Participants Needed

1

Research Sites

147 weeks

Total Duration

On this page

Sponsors

U

University of Nove de Julho

Lead Sponsor

M

Multi Radiance Medical

Collaborating Sponsor

AI-Summary

What this Trial Is About

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

Official Title

Effects of PBMT-sMF in Mechanically Ventilated Patients

Who Can Participate

Age: 21Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • 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 from the time of study enrollment
Not Eligible

You will not qualify if you...

  • Mechanical ventilation started more than 72 hours before anticipated enrollment
  • Body Mass Index (BMI) greater than 40 kg/m²
  • Fever of 100.4°C or higher
  • Prone position for 24 hours or longer during mechanical ventilation
  • Prognosis of death within 72 hours as determined by physician
  • Hypersensitivity to light
  • Use of non-invasive ventilation, CPAP, or BiPAP for 50% or more of the time in the last 6 months
  • Tracheostomy
  • Internal jugular venous cannulation, incisions, significant bruising, burns, skin irritation, rash, or other skin conditions at intended treatment sites on both sides of the neck
  • Fracture, bleeding risk, or acute bleeding in treatment areas
  • Metallic implants or devices in upper body/neck interfering with treatment
  • Non-removable electrical/electronic devices in upper body/neck interfering with treatment, such as pacemaker or defibrillator
  • Cardiogenic or septic shock with severe instability not stabilized within 48 hours
  • Conditions limiting diaphragm ultrasound assessment
  • Current cancer
  • Pregnancy
  • Any comorbidity or condition making participation unsuitable
  • ICU admission for respiratory distress/failure in last 12 months
  • Two or more ICU admissions in last 12 months
  • Current participation in another clinical study

AI-Screening

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Trial Site Locations

Total: 1 location

1

Santa Casa de Misericórdia de Porto Alegre

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

Actively Recruiting

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Research Team

E

Ernesto Leal Junior, PhD

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

QUADRUPLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

2

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