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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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

  • Placebo PBMT-sMF

    Device

    Placebo, without therapeutic dose.

  • Active PBMT-sMF

    Device

    Active with a dose of 31.50 J per site.

Treatment groups

112 Participants
are divided into 2 treatment groups
Group A: PlaceboPlacebo comparator 1 intervention
Group B: ActiveActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Length of stay in the intensive care unit (ICU)

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

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

Secondary outcomes

1

Length of stay in the hospital

Number of days from the patient's admission to the hospital, following discharge from the ICU, to the patient's discharge from the hospital or death from any cause, whichever came first.

Time frame
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.
2

Length of time until weaning from mechanical ventilation (MV)

The number of days from patient initiation on MV until successful weaning.

Time frame
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.
3

Levels of positive end-expiratory pressure levels (PEEP)

The levels of PEEP will be measured using a mechanical ventilator.

Time frame
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.
4

Levels of fraction of inspired oxygen (FiO2)

The levels of PEEP will be measured using a mechanical ventilator.

Time frame
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.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Nove de Julho

Lead sponsor

Multi Radiance Medical

Collaborator

Source ClinicalTrials.gov
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