An interventional study of Active PBMT/sMF and Placebo PBMT/sMF in COVID-19 and Respiratory Failure, sponsored by University of Nove de Julho. Completed at 1 site in Brazil. Open to participants aged 15 Years and older. Per ClinicalTrials.gov, last updated 2020-10-29.
Sponsored by University of Nove de Julho · Not applicable, Interventional, and Treatment
Coronavirus disease 2019 (COVID-19) is a disease caused by a novel coronavirus called SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2). The most characteristic symptom of patients with COVID-19 is respiratory distress, leading to inability to sustain spontaneous breathing. In addition, patients with COVID-19 have dyspnea and respiratory muscle fatigue. Therefore, it is necessary to use strategies that minimize the impact of COVID-19 on the respiratory muscles, accelerating the ventilatory weaning process and optimizing the functional capacity of the involved muscles.
Over the past years, evidence has shown the effectivity of photobiomodulation therapy (PBMT) combined with static magnetic field (sMF) (PBMT/sMF) in delaying muscle fatigue, decrease in markers of inflammatory damage and oxidative stress of skeletal muscle. These effects result in an improvement in the functional capacity of the irradiated muscles by PBMT/sMF. However, do date, there is a lack of evidence regarding the effects of PBMT/sMF on the respiratory muscles.
Therefore, the irradiation of PBMT/sMF may result in improvement in the functional capacity of respiratory muscles in patients with COVID-19, accelerating the ventilatory weaning process of the patients intubated due to respiratory failure. In addition, the irradiation of PBMT/sMF may induce the increase of anti-inflammatory mediators' activity in patients with COVID-19.
Thus, the aim of this project is to investigate the effects of PBMT/sMF on respiratory muscles of patients admitted to the Intensive Care Unit (ICU) with COVID-19 using invasive mechanical ventilation.
To achieve the proposed objectives it will be performed a randomized, triple-blind, placebo-controlled trial, with patients admitted to the adult ICU with COVID-19 using invasive mechanical ventilation due to respiratory failure. The patients will be randomly allocated to two treatment groups: 1. Active PBMT/sMF (MR5™ ACTIV PRO LaserShower) or Placebo PBMT/sMF (MR5™ ACTIV PRO LaserShower). The patients will be treated by a blinded therapist, and the patients will be blinded to the treatment received.
Since there are no studies in this field, initially it will be randomized 30 patients (15 patients per group) to determine the final sample size for this study.
The patients randomly allocated to the two groups will be subjected to treatment once a day, during the ICU stay, until discharge or death.
All data will be collected by a blinded assessor. The investigators will analyze:
The data regarding the blood tests and arterial blood gas analysis will be collected directly from electronic medical record of each patients, since it is a daily hospital routine to perform these blood tests. The data will be collected by two assessors blinded to the treatment applied. The mechanical ventilation control parameters will be collected directly in the mechanical ventilator.
Statistical analysis: All the data will be analyzed by a blinded researcher not involved in data collection. The findings will be tested for their normality using the Kolmogorov-Smirnov test. Parametric data will be expressed as mean and standard deviation and non-parametric data as median and respective upper and lower limits, data can be also expressed as frequency (%). Parametric data will be analysed by two-way repeated measures analysis of variance (time vs experimental group) with post hoc Bonferroni correction. Non-parametric data will be analysed using the Friedman test and, secondarily, the Wilcoxon signed-rank test. The association between categorical variables will be analyzed using the Chi-square test or Fisher's exact test. The significance level will be set at p\<0.05.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's enrollment of 30 is below the median of 100 across 4,099 interventional studies indexed under COVID-19.
Browse COVID-19 studies →University of Nove de Julho is the lead sponsor of 239 studies on the registry; 51 are open to participants now.
Of its 8 completed or terminated interventional studies of FDA-regulated products, 1 (13%) have results posted.
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Exclusion Criteria:
Active PBMT/sMF will be applied once a day, during the ICU stay, until discharge or death. The patients will receive standard physical therapy care associated with PBMT/sMF. PBMT/sMF will be applied using MR5™ ACTIV PRO LaserShower, manufactured by Multi Radiance Medical (Solon, OH, USA). This device has 4 diodes of 905 nm (1.25 mW each diode, 0.32 cm2 each), 8 diodes of 633 nm (25 mW each diode, 0.85 cm2 - each), and 8 diodes of 850 nm (40 mW each diode, 0.56 cm2 - each). The static magnetic field is 110 mT.
Device: Active PBMT/sMF
Placebo PBMT/sMF will be applied once a day, during the ICU stay, until discharge or death. The patients will receive standard physical therapy care associated with placebo PBMT/sMF. The placebo PBMT will be applied using MR5™ ACTIV PRO LaserShower Laser Therapy System, manufactured by Multi Radiance Medical (Solon, OH, USA). The ACTIV PRO emits 905nm, and 850nm via an electric diode energy source with outputs to 0%. The static magnetic field will be also turned off. The 660nm light via an electric diode energy source with outputs to \>1% to appear like the active comparator.
Device: Placebo PBMT/sMF
The PBMT/sMF will be irradiated in the lower thorax and neck areas, with the patients in supine position. PBMT/sMF application time will be 60 seconds per site. The dose used in the lower thorax will be 31.50 J per site, a total of 6 sites will be irradiated, totalizing a dose of 189J. In addition, the dose used in the neck area (bilaterally) will be 31.50J per site, a total of 1 site (bilaterally) will be irradiated, totalizing a dose of 31.50J (bilaterally). PBMT/sMF will be applied using the direct contact method with light pressure on the skin.
The placebo PBMT/sMF will be irradiated in the lower thorax and neck areas, with the patients in supine position. PBMT/sMF application time will be 60 seconds per site. The dose used for applications during the treatment will be 0 Joules (J) per site. The sounds and signals emitted from the device as well as the information displayed on the screen will be identical, regardless of the type of treatment (active or placebo). PBMT/sMF will be applied using the direct contact method with light pressure on the skin.
Time until discharge
Number of days hospitalized in the ICU until discharge or death.
Time frame: From date of randomization until the date of discharge or date of death from any cause, whichever came first, assessed up to 20 days.
Survival rate
Rate of how many people survived and were discharged and how many died.
Time frame: From date of randomization until the date of discharge or date of death from any cause, whichever came first, assessed up to 20 days.
Diaphragm muscle function
Diaphragm thickness will be measured by ultrasound.
Time frame: 10 days after randomization and in the last test before discharge or death from any cause, whichever came first, assessed up to 20 days.
Platelet count
Platelet count will be measured by blood test.
Time frame: 10 days after randomization and in the last test before discharge or death from any cause, whichever came first, assessed up to 20 days.
Leukogram
Leukogram will be measured by blood test.
Time frame: 10 days after randomization and in the last test before discharge or death from any cause, whichever came first, assessed up to 20 days.
Erythrogram
Erythrogram will be measured by blood test.
Time frame: 10 days after randomization and in the last test before discharge or death from any cause, whichever came first, assessed up to 20 days.
C-reactive protein
C-reactive protein will be measured by blood test.
Time frame: 10 days after randomization and in the last test before discharge or death from any cause, whichever came first, assessed up to 20 days.
D-dimer
D-dimer will be measured by blood test.
Time frame: 10 days after randomization and in the last test before discharge or death from any cause, whichever came first, assessed up to 20 days.
Immunoglobulin G
Immunoglobulin G will be measured by blood test.
Time frame: 10 days after randomization and in the last test before discharge or death from any cause, whichever came first, assessed up to 20 days.
Immunoglobulin M
Immunoglobulin M will be measured by blood test.
Time frame: 10 days after randomization and in the last test before discharge or death from any cause, whichever came first, assessed up to 20 days.
Levels of positive end-expiratory pressure (PEEP)
The levels of PEEP will be measured using a mechanical ventilator.
Time frame: 10 days after randomization and in the last test before discharge or death from any cause, whichever came first, assessed up to 20 days.
Fraction of inspired oxygen (FiO2)
The levels of FiO2 will be measured using a mechanical ventilator.
Time frame: 10 days after randomization and in the last test before discharge or death from any cause, whichever came first, assessed up to 20 days.
Arterial partial pressure of oxygen (PO2)
PO2 will be measured by arterial blood gas analysis.
Time frame: 10 days after randomization and in the last test before discharge or death from any cause, whichever came first, assessed up to 20 days.
Arterial partial pressure of oxygen (PO2)/Fraction of inspired oxygen (FiO2) ratio
PO2/FiO2 ratio will be measured by arterial blood gas analysis.
Time frame: 10 days after randomization and in the last test before discharge or death from any cause, whichever came first, assessed up to 20 days.
Levels of tumor necrosis factor-α (TNF-α)
Levels of TNF-α will be measured by blood test.
Time frame: 10 days after randomization and in the last test before discharge or death from any cause, whichever came first, assessed up to 20 days.
Levels of vitamin D
Levels of vitamin D will be measured by blood test.
Time frame: 10 days after randomization and in the last test before discharge or death from any cause, whichever came first, assessed up to 20 days.
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