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

Abstract

Thiago De Marchi,1,2 Fabiano Frâncio,1,3 João Vitor Ferlito,3 Renata Weigert,3 Cristiane de Oliveira,3 Ana Paula Merlo,3 Délcio Luis Pandini,3 Bolivar Antônio Pasqual-Júnior,3 Daniela Giovanella,3 Shaiane Silva Tomazoni,4,5 Ernesto Cesar Leal-Junior2,4,5 1University Center of Bento Gonçalves (UNICNEC), Bento Gonçalves, Rio Grande do Sul, Brazil; 2Laboratory of Phototherapy and Innovative Technologies in Health (LaPIT), Post-graduate Program in Rehabilitation Sciences, Nove de Julho University, São Paulo, Brazil; 3Hospital Tacchini, Bento Gonçalves, Rio Grande do Sul, Brazil; 4Physiotherapy Research Group, Department of Global Public Health and Primary Care, University of Bergen, Bergen, Norway; 5ELJ Consultancy, Scientific Consultants, São Paulo, BrazilCorrespondence: Shaiane Silva TomazoniPhysiotherapy Research Group, Department of Global Public Health and Primary Care, University of Bergen, Alrek helseklynge, blokk D, Årstadveien 17, Bergen, NO-5020, NorwayEmail [email protected]: 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 Trials.gov): NCT04386694.Keywords: COVID-19, photobiomodulation, intensive care unit, respiratory muscles, ventilatory parameters, mechanical ventilation

Keywords

• covid-19
• photobiomodulation
• intensive care unit
• respiratory muscles
• ventilatory parameters
• mechanical ventilation