Is Photobiomodulation Therapy (PBMT) Combined With Static Magnetic Field (sMF) Able to Decrease the Intensive Care Unit (ICU) Length of Stay for Patients With COVID-19?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Time until discharge
研究概览
简要总结
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.
详细描述
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:
- Number of days hospitalized in the ICU until discharge or death.
- Survival rate: rate of how many people survived and were discharged and how many died.
- Muscular function of the diaphragm: the first assessment will be performed within 24 hours after the patient's intubation, the second 10 days after the first, and the third at the pre-discharge from the ICU.
- Blood tests: baseline (admission to the ICU), 10 days after the admission, and endpoint (discharge or death).
- Mechanical ventilation control parameters: baseline (admission to the ICU), 10 days after the admission, and endpoint (discharge or death).
- Arterial Blood Gas Analysis: baseline (admission to the ICU), 10 days after the admission, and endpoint (discharge or death).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
A researcher will program the device (PMBT/sMF or placebo) and will be instructed not to inform the patients or other researchers as to the type of treatment (PMBT/sMF or placebo). Therefore, the therapist responsible for the treatment, the investigators and the outcome assessors will be blinded to the type of treatment being administered to the patients. 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 (PBMT/sMF or placebo).
入排标准
- 年龄范围
- 15 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients admitted to the adult Intensive Care Unit with Covid-19 infection;
- •Need for orotracheal intubation;
- •Invasive mechanical ventilation due to respiratory failure.
排除标准
- •Suspected patients who had a negative result of the diagnostic examination for COVID-19 infection;
- •Patients positioned in pronation for more than 24 hours;
- •Cancer patients;
- •Pregnancy.
结局指标
主要结局
Time until discharge
时间窗: From date of randomization until the date of discharge or date of death from any cause, whichever came first, assessed up to 20 days.
Number of days hospitalized in the ICU until discharge or death.
次要结局
- Survival rate(From date of randomization until the date of discharge or date of death from any cause, whichever came first, assessed up to 20 days.)
- Platelet count(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(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(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)(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(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(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)(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)(10 days after randomization and in the last test before discharge or death from any cause, whichever came first, assessed up to 20 days.)
- Diaphragm muscle function(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(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(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)(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(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(10 days after randomization and in the last test before discharge or death from any cause, whichever came first, assessed up to 20 days.)
研究者
Ernesto Cesar Pinto Leal Junior
Full professor
University of Nove de Julho