Effects of PBMT-sMF in Mechanically Ventilated Patients

ConditionRespiratory Failure

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age21+

SponsorUniversity of Nove de Julho

About this trial

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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;

Trial design

Treatments tested in this trial

Placebo PBMT-sMF
Active PBMT-sMF

Treatment groups

112 Participants

are divided into 2 treatment groups

Sponsors and collaborators

University of Nove de Julho

Lead sponsor

Multi Radiance Medical

Collaborator

Source ClinicalTrials.gov