Blue Light as an Anti-inflammatory and Analgesic Strategy in Thoracic Trauma

Chest wall pain intensity with deep breathing will be measured using the Numerical Rating Scale, elicited when the participant is taking a full tidal volume breath using their incentive spirometer. The Numerical Rating Scale is an 11-point scale ranging from 0 to 10, with 0 representing no pain and 10 representing the worst pain imaginable. The scale will then be assessed at multiple timepoints during the 72 hour period of active study participation including twice daily on up to three intervention days (study days 1-3) and once on the morning following the final intervention day (study day 4 or day of discharge). Pain scale values over time will be compared across study arms.

Intensive care unit-free days at 30 days is calculated as 30 minus the number of days spent in an intensive care unit. Participants with death occurring within 30 days of enrollment will be assigned 0 ICU-free days. This will be assessed at 30 days using chart review and, for patients discharged from the hospital, confirmed during a single follow-up phone call. Thus, the range for each participant will be from 0 to 30 days. Differences in ICU-free days will be compared across study arms.

Rev-Erb alpha is a circadian clock protein that will be used as a surrogate for circadian clock activation. Rev-Erb alpha expression will be quantified using Western Blot on blood samples collected each morning for up to 4 collections over the course of active study participation. Rev-erb alpha expression over time will be compared across study arms.

Pro-inflammatory cytokine IL-6 concentration (pg/mL) will be quantified using ELISA testing on blood samples collected each morning for up to 4 collections over the course of active study participation. IL-6 concentration over time will be compared across study arms.

Pro-inflammatory cytokine TNF-alpha concentration (pg/mL) will be quantified using ELISA testing on blood samples collected each morning for up to 4 collections over the course of active study participation. TNF-alpha concentration over time will be compared across study arms.

Anti-inflammatory cytokine IL-10 concentration (pg/mL) will be quantified using ELISA testing on blood samples collected each morning for up to 4 collections over the course of active study participation. IL-10 concentration over time will be compared across study arms.

Daily opioid requirements as quantified by standardized oral morphine equivalents (OME) will be calculated daily during up to 72 hours of active study participation using opioid use data abstracted from the electronic medical record and a comprehensive OME conversion table. Opioid requirements over time will be compared across study arms.

Chest wall pain intensity at rest will be measured using the Numerical Rating Scale, elicited when the participant is at rest. The Numerical Rating Scale is an 11-point scale ranging from 0 to 10, with 0 representing no pain and 10 representing the worst pain imaginable. The scale will assessed at baseline for the purpose of eligibility screening. The scale will then be assessed at multiple timepoints during the 72 hour period of active study participation, including twice daily during up to three intervention days and once on the morning following the final intervention day. Pain scale values over time will be compared across study arms.

Hospital-free days at 30 days is calculated as 30 minus the number of days spent in an acute-care hospital, long-term acute care hospital (LTACH), or in an emergency department (ED). Participants with death occurring within 30 days of enrollment will be assigned 0 hospital-free days. This will be assessed at 30 days using chart review and, for patients discharged from the hospital, confirmed during a single follow-up phone call. Thus, the range for each participant will be from 0 to 30 days. Differences in hospital-free days will be compared across study arms.

The presence or absence of delirium will be assessed using the 3-minute diagnostic interview for Confusion Assessment Method-defined delirium (3D-CAM). Based on the bedside assessment, a published algorithm deems the participant either positive or negative for delirium. The assessment will then be administered at multiple timepoints during the 72 hour period of active study participation, including daily on each intervention day (study days 1-3) and on the morning following the final intervention day (study day 4 or day of discharge). The incidence of delirium within this timeframe will be compared across study arms.

Pulmonary complications are defined by a composite outcome (clinical pneumonia OR respiratory insufficiency requiring non-invasive positive pressure ventilation OR respiratory failure requiring mechanical ventilation). This dichotomous (yes/no) outcome will be assessed for each participant by electronic medical record review at 30 days post-enrollment. The incidence of pulmonary complications within this timeframe will be compared across study arms.