Photobiomodulation Therapy Combined With Static Magnetic Field in Patients With COVID-19

COVID-19 Clinical Trial

Official title:

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?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04386694
• Other study ID #: 3.985.226
• Status: Completed
• Phase: N/A
• Start date: May 18, 2020
• Est. completion date: September 17, 2020

Study information

• Verified date: October 2020
• Source: University of Nove de Julho
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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:

1. Number of days hospitalized in the ICU until discharge or death.

2. Survival rate: rate of how many people survived and were discharged and how many died.

3. 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.

4. Blood tests: baseline (admission to the ICU), 10 days after the admission, and endpoint (discharge or death).

5. Mechanical ventilation control parameters: baseline (admission to the ICU), 10 days after the admission, and endpoint (discharge or death).

6. Arterial Blood Gas Analysis: baseline (admission to the ICU), 10 days after the admission, and endpoint (discharge or death).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 17, 2020
• Est. primary completion date: September 17, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 15 Years and older

Eligibility

Inclusion Criteria:

• Patients admitted to the adult Intensive Care Unit with Covid-19 infection;

• Need for orotracheal intubation;

• Invasive mechanical ventilation due to respiratory failure.

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• COVID-19
• Respiratory Failure
• Respiratory Insufficiency

Intervention

Device:
• Active 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.
• Placebo PBMT/sMF
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.

Locations

Country	Name	City	State
Brazil	Hospital Tacchini	Bento Gonçalves	RS

Sponsors (2)

Lead Sponsor	Collaborator
University of Nove de Julho	Hospital Tacchini/RS

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time until discharge	Number of days hospitalized in the ICU until discharge or death.	From date of randomization until the date of discharge or date of death from any cause, whichever came first, assessed up to 20 days.
Secondary	Survival rate	Rate of how many people survived and were discharged and how many died.	From date of randomization until the date of discharge or date of death from any cause, whichever came first, assessed up to 20 days.
Secondary	Diaphragm muscle function	Diaphragm thickness will be measured by ultrasound.	10 days after randomization and in the last test before discharge or death from any cause, whichever came first, assessed up to 20 days.
Secondary	Platelet count	Platelet count will be measured by blood test.	10 days after randomization and in the last test before discharge or death from any cause, whichever came first, assessed up to 20 days.
Secondary	Leukogram	Leukogram will be measured by blood test.	10 days after randomization and in the last test before discharge or death from any cause, whichever came first, assessed up to 20 days.
Secondary	Erythrogram	Erythrogram will be measured by blood test.	10 days after randomization and in the last test before discharge or death from any cause, whichever came first, assessed up to 20 days.
Secondary	C-reactive protein	C-reactive protein will be measured by blood test.	10 days after randomization and in the last test before discharge or death from any cause, whichever came first, assessed up to 20 days.
Secondary	D-dimer	D-dimer will be measured by blood test.	10 days after randomization and in the last test before discharge or death from any cause, whichever came first, assessed up to 20 days.
Secondary	Immunoglobulin G	Immunoglobulin G will be measured by blood test.	10 days after randomization and in the last test before discharge or death from any cause, whichever came first, assessed up to 20 days.
Secondary	Immunoglobulin M	Immunoglobulin M will be measured by blood test.	10 days after randomization and in the last test before discharge or death from any cause, whichever came first, assessed up to 20 days.
Secondary	Levels of positive end-expiratory pressure (PEEP)	The levels of PEEP will be measured using a mechanical ventilator.	10 days after randomization and in the last test before discharge or death from any cause, whichever came first, assessed up to 20 days.
Secondary	Fraction of inspired oxygen (FiO2)	The levels of FiO2 will be measured using a mechanical ventilator.	10 days after randomization and in the last test before discharge or death from any cause, whichever came first, assessed up to 20 days.
Secondary	Arterial partial pressure of oxygen (PO2)	PO2 will be measured by arterial blood gas analysis.	10 days after randomization and in the last test before discharge or death from any cause, whichever came first, assessed up to 20 days.
Secondary	Arterial partial pressure of oxygen (PO2)/Fraction of inspired oxygen (FiO2) ratio	PO2/FiO2 ratio will be measured by arterial blood gas analysis.	10 days after randomization and in the last test before discharge or death from any cause, whichever came first, assessed up to 20 days.
Secondary	Levels of tumor necrosis factor-a (TNF-a)	Levels of TNF-a will be measured by blood test.	10 days after randomization and in the last test before discharge or death from any cause, whichever came first, assessed up to 20 days.
Secondary	Levels of vitamin D	Levels of vitamin D will be measured by blood test.	10 days after randomization and in the last test before discharge or death from any cause, whichever came first, assessed up to 20 days.