Effects of Photobiomodulation Therapy Combined with Static Magnetic Field in Severe COVID-19 Patients Requiring Intubation: A Pragmatic Randomized Placebo-Controlled Trial

Abstract

Purpose: We aimed to investigate the effects of photobiomodulation therapy combined with static magnetic field (PBMT-sMF) on the length of intensive care unit (ICU) stay and mortality rate of severe COVID-19 patients requiring invasive mechanical ventilation and assess its role in preserving respiratory muscles and modulating inflammatory processes.

Patients and methods: We conducted a prospectively registered, triple-blinded, randomized, placebo-controlled trial of PBMT-sMF in severe COVID-19 ICU patients requiring invasive mechanical ventilation. Patients were randomly assigned to receive either PBMT-sMF or a placebo daily throughout their ICU stay. The primary outcome was length of ICU stay, defined by either discharge or death. The secondary outcomes were survival rate, diaphragm muscle function, and the changes in blood parameters, ventilatory parameters, and arterial blood gases.

Results: Thirty patients were included and equally randomized into the two groups. There were no significant differences in the length of ICU stay (mean difference, MD = -6.80; 95% CI = -18.71 to 5.11) between the groups. Among the secondary outcomes, significant differences were observed in diaphragm thickness, fraction of inspired oxygen, partial pressure of oxygen/fraction of inspired oxygen ratio, C-reactive protein levels, lymphocyte count, and hemoglobin (p < 0.05).

Conclusion: Among severe COVID-19 patients requiring invasive mechanical ventilation, the length of ICU stay was not significantly different between the PBMT-sMF and placebo groups. In contrast, PBMT-sMF was significantly associated with reduced diaphragm atrophy, improved ventilatory parameters and lymphocyte count, and decreased C-reactive protein levels and hemoglobin count.

Trial registration number clinical trialsgov: NCT04386694.

Keywords: COVID-19; intensive care unit; mechanical ventilation; photobiomodulation; respiratory muscles; ventilatory parameters.

Conflict of interest statement

Professor Ernesto Cesar Pinto Leal-Junior receives research support from Multi Radiance Medical (Solon, OH, USA), a laser device manufacturer. Professor Ernesto Cesar Pinto Leal-Junior also has a patent Laser therapy for patients requiring mechanical ventilation pending to Multi Radiance Medical. Shaiane Silva Tomazoni has a personal relationship with Ernesto Cesar Pinto Leal-Junior. Multi Radiance Medical had no role in the planning, conducting, and analysis of the data. The remaining authors declare that they have no support from any organizations for the submitted work; no financial relationships with any organizations that might have an interest in the submitted work in the past three years; and no other relationships or activities that could appear to have influenced the submitted work.

© 2021 De Marchi et al.

Figures

Figure 1

PBMT-sMF device. Figure 1 shows the device used to applied the PBMT-sMF and placebo. A cluster probe with 20 diodes containing 4 diodes of 905 nm, 8 diodes of 633 nm and 8 diodes of 850 nm was used: A - Red LEDs; B - Infrared LEDs; C - Super-pulsed laser; D - Magnetic field.

Figure 2

Irradiation of interventions. (A) shows the sites where PBMT-sMF and placebo were irradiated. The interventions were irradiated at six sites in the lower thorax/upper abdominal cavity and two sites in the neck area. (B) shows the full description of the parameters of PBMT-sMF applied in the treatment. This figure is owned by the authors.

Figure 3

CONSORT flow diagram of the study. Figure 3 shows the flow diagram of the study including enrollment, randomization, intervention allocation, follow-up and data analysis of the two groups.