Respiratory FailureNCT06454006
Effects of PBMT-sMF in Mechanically Ventilated Patients
A study testing Active PBMT-sMF in people with Respiratory Failure, run by University of Nove de Julho at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Respiratory Failure
- What is being tested?
- Active PBMT-sMF
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 112 participants
- Where
- 1 siteBrazil
- Study dates
- 31 Jul 2024to Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
Show all 20Show fewer
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site, 1 recruiting
- Recruiting
Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035-074
Jociane Schardong, PhD, + 55 11 990065829, joci_fisioufsm@yahoo.com.br
About this study
Official title: 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
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.
Read the detailed description
To achieve the proposed objectives it will be performed a multi-center, randomized, triple-blinded (patients, therapists, outcome assessors), placebo-controlled trial, in patients who required mechanical ventilation.
One hundred and twelve patients will be randomly allocated to two treatment groups:
- Active treatment: Patients will receive treatment with the active PBMT-sMF combined with standard of care therapy for a mechanically ventilated patient in the ICU.
- Placebo treatment: Patients will receive treatment with the placebo PBMT-sMF combined with standard of care therapy for a mechanically ventilated patient in the ICU.
The randomization will occur immediately following patients qualification and prior to any additional study activities occurring.
The treatment administration protocol (28-day administration protocol) will comprise: 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 patient's successful weaning from mechanical ventilation, or until the day of the patient's death, whichever occurs first.
The data will be collected by a blinded assessor.
Due to the nature of the condition being evaluated in this study, the study assessment timeline is patient dependent and will therefore be unique to each patient.
The study will comprise:
- pre-treatment evaluation phase (before starting treatment);
- treatment administration phase (two assessments: after completion of 14 and 28 days of treatment);
- post-treatment evaluation phase (any patient who is not discharged from the hospital or who does not die during the treatment administration and evaluation phase will proceed to the post-treatment administration phase. The post-treatment phase will start on the day immediately following the patient's last day in the treatment administration evaluation phase. The post-treatment phase will end on the day that the patient is discharged from the hospital, or the day that the patient dies prior to discharge from the hospital, whichever occurs firs. Therefore, the duration of the post-treatment administration phase will vary by individual patient. During the post-treatment evaluation period, the following assessments will be recorded once every two weeks, as applicable, with the final post-treatment evaluation visit determined on an individual patient basis, up to 2 years).
P.S.:
- For patients whose successful weaning from mechanical ventilation occurs prior to completion of the 28-day administration protocol, the endpoint assessment visit will occur on or after the day of successful weaning.
- For patients who die before completion of the 28-day administration protocol, the endpoint assessment visit will include outcome measures recorded as close to the date of the patient's death as possible.
The investigators will analyze: 1) Length of stay in the ICU; 2) Diaphragm thickness; 3) Length of stay in the hospital following ICU discharge; 4) Length of time until weaning from mechanical ventilation; 5) Mechanical ventilation parameters: (i) Positive end-expiratory pressure levels (PEEP) and (ii) Fraction of inspired oxygen (FiO2); 6) Arterial blood gas analysis: (i) Arterial partial pressure of oxygen (PO2) and (ii)PO2/FiO2 ratio; 7) Vital signs: blood pressure, heart rate, SpO2, blood glucose, etc.; 8) Blood draw analysis: C-reactive protein (CRP); Tumor necrosis factor-alpha (TNF-α); Vitamin D; erythrocytes; hemoglobin; hematocrit; leucocytes; segmented neutrals; eosinophiles; basophiles; lymphocytes; monocytes; platelet count;8) Survival rate; 9) Local skin reactions; 10) Adverse events and serious adverse events.
The statistical analysis will follow the intention-to-treat principles.
- Conditions
- Respiratory Failure
- Being tested
- Placebo PBMT-sMF, Active PBMT-sMF
- Keywords
- Mechanical ventilation, Photobiomodulation therapy, LLLT, Static magnetic field, Diaphragm, Intensive care unit
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo PBMT-sMFDevice
Placebo, without therapeutic dose.
Active PBMT-sMFDevice
Active with a dose of 31.50 J per site.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Device: Active PBMT-sMF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of stay in the intensive care unit (ICU)
Number of days hospitalized in the ICU until discharge from ICU.
Measured: From date of ICU admission until the date of discharge of the ICU.
Secondary outcomes (21)
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.
Measured: 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)
The number of days from patient initiation on MV until successful weaning.
Measured: 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)
The levels of PEEP will be measured using a mechanical ventilator.
Measured: 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)
The levels of PEEP will be measured using a mechanical ventilator.
Measured: 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)
PO2 will be measured by arterial blood gas analysis.
Measured: 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.
Arterial partial pressure of oxygen (PO2)/Fraction of inspired oxygen (FiO2) ratio
PO2 will be measured by arterial blood gas analysis.
Measured: 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.
C-reactive protein (CRP)
CRP will be measured by blood test.
Measured: After 14 days of treatment; after 28 days of treatment; and once every two weeks after discharge from ICU until the date of discharge of hospital or death from any cause, whichever came first, up to 2 years.
Erythrocytes
Erythrocytes will be measured by blood test.
Measured: After 14 days of treatment; after 28 days of treatment; and once every two weeks after discharge from ICU until the date of discharge of hospital or death from any cause, whichever came first, up to 2 years.
Hemoglobin
Hemoglobin will be measured by blood test.
Measured: After 14 days of treatment; after 28 days of treatment; and once every two weeks after discharge from ICU until the date of discharge of hospital or death from any cause, whichever came first, up to 2 years.
Hematocrit
Hematocrit will be measured by blood test.
Measured: After 14 days of treatment; after 28 days of treatment; and once every two weeks after discharge from ICU until the date of discharge of hospital or death from any cause, whichever came first, up to 2 years.
Leucocytes
Leucocytes will be measured by blood test.
Measured: After 14 days of treatment; after 28 days of treatment; and once every two weeks after discharge from ICU until the date of discharge of hospital or death from any cause, whichever came first, up to 2 years.
Segmented neutrals
Segmented neutrals will be measured by blood test.
Measured: After 14 days of treatment; after 28 days of treatment; and once every two weeks after discharge from ICU until the date of discharge of hospital or death from any cause, whichever came first, up to 2 years.
Eeosinophiles
Eosinophiles will be measured by blood test.
Measured: After 14 days of treatment; after 28 days of treatment; and once every two weeks after discharge from ICU until the date of discharge of hospital or death from any cause, whichever came first, up to 2 years.
Basophiles
Basophiles will be measured by blood test.
Measured: After 14 days of treatment; after 28 days of treatment; and once every two weeks after discharge from ICU until the date of discharge of hospital or death from any cause, whichever came first, up to 2 years.
Lymphocytes
Lymphocytes will be measured by blood test.
Measured: After 14 days of treatment; after 28 days of treatment; and once every two weeks after discharge from ICU until the date of discharge of hospital or death from any cause, whichever came first, up to 2 years.
Monocytes
Monocytes will be measured by blood test.
Measured: After 14 days of treatment; after 28 days of treatment; and once every two weeks after discharge from ICU until the date of discharge of hospital or death from any cause, whichever came first, up to 2 years.
Platelet count
Platelet count will be measured by blood test.
Measured: After 14 days of treatment; after 28 days of treatment; and once every two weeks after discharge from ICU until the date of discharge of hospital or death from any cause, whichever came first, up to 2 years.
Survival rate
Rate of how many people survived and were discharged and how many died.
Measured: After 14 days of treatment; after 28 days of treatment; and once every two weeks after discharge from ICU until the date of discharge of hospital or death from any cause, whichever came first, up to 2 years.
Local skin reactions
Local skin reaction will be measured by four-point post-treatment assessment severity scale
Measured: After each treatment administration up to 28 days.
Adverse events
All adverse events that occur after randomization, including local and systemic reactions, not meeting the criteria for serious adverse events will be captured on the appropriate adverse event case report form.
Measured: Adverse events will be collected throughout study duration up to 2 years.
End-expiratory diaphragm thickness
Diaphragm thickness will be measured by ultrasound.
Measured: After 14 days of treatment; after 28 days of treatment; and once every two weeks after discharge from ICU until the date of discharge of hospital or death from any cause, whichever came first, up to 2 years.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start31 Jul 2024
- Primary completionDec 2026 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 112 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Collaborators
- Multi Radiance Medical
- Responsible party
- Principal investigator, Ernesto Cesar Pinto Leal Junior, University of Nove de Julho
- Investigators
- Ernesto Leal Junior, PhD, Principal investigator, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06454006
- Sponsor's protocol ID
- 6.738.501
- Status last verified
- Apr 2026
- First submitted
- 28 May 2024
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: The IPD will be available on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06454006
- Acronym / sponsor ID
- 6.738.501
- Conditions
- Respiratory Failure
- Keywords
- Mechanical ventilation, Photobiomodulation therapy, LLLT, Static magnetic field, Diaphragm, Intensive care unit
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 112 participants (estimated)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Collaborators
- Multi Radiance Medical
- Study start
- 31 Jul 2024 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 12 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
To achieve the proposed objectives it will be performed a multi-center, randomized, triple-blinded (patients, therapists, outcome assessors), placebo-controlled trial, in patients who required mechanical ventilation.
One hundred and twelve patients will be randomly allocated to two treatment groups:
- Active treatment: Patients will receive treatment with the active PBMT-sMF combined with standard of care therapy for a mechanically ventilated patient in the ICU.
- Placebo treatment: Patients will receive treatment with the placebo PBMT-sMF combined with standard of care therapy for a mechanically ventilated patient in the ICU.
The randomization will occur immediately following patients qualification and prior to any additional study activities occurring.
The treatment administration protocol (28-day administration protocol) will comprise: 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 patient's successful weaning from mechanical ventilation, or until the day of the patient's death, whichever occurs first.
The data will be collected by a blinded assessor.
Due to the nature of the condition being evaluated in this study, the study assessment timeline is patient dependent and will therefore be unique to each patient.
The study will comprise:
- pre-treatment evaluation phase (before starting treatment);
- treatment administration phase (two assessments: after completion of 14 and 28 days of treatment);
- post-treatment evaluation phase (any patient who is not discharged from the hospital or who does not die during the treatment administration and evaluation phase will proceed to the post-treatment administration phase. The post-treatment phase will start on the day immediately following the patient's last day in the treatment administration evaluation phase. The post-treatment phase will end on the day that the patient is discharged from the hospital, or the day that the patient dies prior to discharge from the hospital, whichever occurs firs. Therefore, the duration of the post-treatment administration phase will vary by individual patient. During the post-treatment evaluation period, the following assessments will be recorded once every two weeks, as applicable, with the final post-treatment evaluation visit determined on an individual patient basis, up to 2 years).
P.S.:
- For patients whose successful weaning from mechanical ventilation occurs prior to completion of the 28-day administration protocol, the endpoint assessment visit will occur on or after the day of successful weaning.
- For patients who die before completion of the 28-day administration protocol, the endpoint assessment visit will include outcome measures recorded as close to the date of the patient's death as possible.
The investigators will analyze: 1) Length of stay in the ICU; 2) Diaphragm thickness; 3) Length of stay in the hospital following ICU discharge; 4) Length of time until weaning from mechanical ventilation; 5) Mechanical ventilation parameters: (i) Positive end-expiratory pressure levels (PEEP) and (ii) Fraction of inspired oxygen (FiO2); 6) Arterial blood gas analysis: (i) Arterial partial pressure of oxygen (PO2) and (ii)PO2/FiO2 ratio; 7) Vital signs: blood pressure, heart rate, SpO2, blood glucose, etc.; 8) Blood draw analysis: C-reactive protein (CRP); Tumor necrosis factor-alpha (TNF-α); Vitamin D; erythrocytes; hemoglobin; hematocrit; leucocytes; segmented neutrals; eosinophiles; basophiles; lymphocytes; monocytes; platelet count;8) Survival rate; 9) Local skin reactions; 10) Adverse events and serious adverse events.
The statistical analysis will follow the intention-to-treat principles.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Device: Placebo PBMT-sMFPlacebo 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. |
| Active | Active comparator | Device: Active PBMT-sMFActive 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. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (20 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Placebo PBMT-sMFPlacebo, without therapeutic dose. | Device | Placebo |
| Active PBMT-sMFActive with a dose of 31.50 J per site. | Device | Active |
Primary outcome
Length of stay in the intensive care unit (ICU)
Time frame: From date of ICU admission until the date of discharge of the ICU.
Number of days hospitalized in the ICU until discharge from ICU.
21 secondary outcomes
Length of stay in the hospital
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.
Length of time until weaning from mechanical ventilation (MV)
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.
Levels of positive end-expiratory pressure levels (PEEP)
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.
Levels of fraction of inspired oxygen (FiO2)
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.
Arterial partial pressure of oxygen (PO2)
Time frame: 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.
Arterial partial pressure of oxygen (PO2)/Fraction of inspired oxygen (FiO2) ratio
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.
C-reactive protein (CRP)
Time frame: After 14 days of treatment; after 28 days of treatment; and once every two weeks after discharge from ICU until the date of discharge of hospital or death from any cause, whichever came first, up to 2 years.
Erythrocytes
Time frame: After 14 days of treatment; after 28 days of treatment; and once every two weeks after discharge from ICU until the date of discharge of hospital or death from any cause, whichever came first, up to 2 years.
Hemoglobin
Time frame: After 14 days of treatment; after 28 days of treatment; and once every two weeks after discharge from ICU until the date of discharge of hospital or death from any cause, whichever came first, up to 2 years.
Hematocrit
Time frame: After 14 days of treatment; after 28 days of treatment; and once every two weeks after discharge from ICU until the date of discharge of hospital or death from any cause, whichever came first, up to 2 years.
Leucocytes
Time frame: After 14 days of treatment; after 28 days of treatment; and once every two weeks after discharge from ICU until the date of discharge of hospital or death from any cause, whichever came first, up to 2 years.
Segmented neutrals
Time frame: After 14 days of treatment; after 28 days of treatment; and once every two weeks after discharge from ICU until the date of discharge of hospital or death from any cause, whichever came first, up to 2 years.
Eeosinophiles
Time frame: After 14 days of treatment; after 28 days of treatment; and once every two weeks after discharge from ICU until the date of discharge of hospital or death from any cause, whichever came first, up to 2 years.
Basophiles
Time frame: After 14 days of treatment; after 28 days of treatment; and once every two weeks after discharge from ICU until the date of discharge of hospital or death from any cause, whichever came first, up to 2 years.
Lymphocytes
Time frame: After 14 days of treatment; after 28 days of treatment; and once every two weeks after discharge from ICU until the date of discharge of hospital or death from any cause, whichever came first, up to 2 years.
Monocytes
Time frame: After 14 days of treatment; after 28 days of treatment; and once every two weeks after discharge from ICU until the date of discharge of hospital or death from any cause, whichever came first, up to 2 years.
Platelet count
Time frame: After 14 days of treatment; after 28 days of treatment; and once every two weeks after discharge from ICU until the date of discharge of hospital or death from any cause, whichever came first, up to 2 years.
Survival rate
Time frame: After 14 days of treatment; after 28 days of treatment; and once every two weeks after discharge from ICU until the date of discharge of hospital or death from any cause, whichever came first, up to 2 years.
Local skin reactions
Time frame: After each treatment administration up to 28 days.
Adverse events
Time frame: Adverse events will be collected throughout study duration up to 2 years.
End-expiratory diaphragm thickness
Time frame: After 14 days of treatment; after 28 days of treatment; and once every two weeks after discharge from ICU until the date of discharge of hospital or death from any cause, whichever came first, up to 2 years.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Individual participant dataSharing planned: Yes. The IPD will be available on reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Ernesto Leal Junior, PhD principal investigator
University of Nove de Julho
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Active PBMT-sMF in people with Respiratory Failure, run by University of Nove de Julho at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ernesto Leal Junior, PhD (+551133859134, ernesto.leal.junior@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Length of stay in the intensive care unit (ICU) (time frame: From date of ICU admission until the date of discharge of the ICU.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2026; AzTrials last refreshed its copy on 26 Oct 2026.