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.
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: 1. 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. 2. 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: 1. pre-treatment evaluation phase (before starting treatment); 2. treatment administration phase (two assessments: after completion of 14 and 28 days of treatment); 3. 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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
112
Placebo, without therapeutic dose.
Active with a dose of 31.50 J per site.
Santa Casa de Misericórdia de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
RECRUITINGLength of stay in the intensive care unit (ICU)
Number of days hospitalized in the ICU until discharge from ICU or death from any cause.
Time frame: From date of ICU admission until the date of discharge or date of death from any cause, whichever came first, assessed up to 28 days.
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.
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.
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.
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.
Arterial partial pressure of oxygen (PO2)
PO2 will be measured by arterial blood gas analysis.
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
PO2 will be measured by arterial blood gas analysis.
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)
CRP will be measured by blood test.
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
Erythrocytes will be measured by blood test.
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
Hemoglobin will be measured by blood test.
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
Hematocrit will be measured by blood test.
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
Leucocytes will be measured by blood test.
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
Segmented neutrals will be measured by blood test.
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
Eosinophiles will be measured by blood test.
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
Basophiles will be measured by blood test.
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
Lymphocytes will be measured by blood test.
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
Monocytes will be measured by blood test.
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
Platelet count will be measured by blood test.
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
Rate of how many people survived and were discharged and how many died.
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
Local skin reaction will be measured by four-point post-treatment assessment severity scale
Time frame: 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.
Time frame: Adverse events will be collected throughout study duration up to 2 years.
End-expiratory diaphragm thickness
Diaphragm thickness will be measured by ultrasound.
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.