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

Официальное название

Blue Light as an Anti-inflammatory and Analgesic Strategy in Thoracic Trauma: A Randomized Controlled Trial in Adults With Rib Fractures

Обзор

The main goal of this clinical trial is to learn if light therapy improves pain and inflammation in adults with painful rib fractures. The main question it aims to answer is: \- Does bright blue light therapy in addition to standard pain treatments improve pain with breathing in adults with painful rib fractures? Researchers will compare participants who receive bright blue light therapy to participants who receive white light therapy and participants who receive only usual lighting conditions to look for differences in their pain control. In addition to their assigned light treatment, all participants will receive standard pain control treatments. Participants will be assigned randomly to one of three groups: one-third will be assigned to bright blue light therapy, one-third will be assigned to bright white light therapy, and one-third will be assigned to usual light only. They will receive their assigned light treatment for 4 hours during the morning/early afternoon for up to 3 days while they are in the hospital. On each day they receive the light treatment and on the day after their final light treatment: * They will be asked twice to rate their pain at rest and with taking a deep breath. * They will be tested to confirm that they are not experiencing delirium, or confusion related to being in the hospital. * Blood samples will be collected to look for changes in inflammation and the circadian clock, the body's natural 24-hour cycle.

Вмешательства

• Устройство Bright Blue Light
  Bright blue light will be administered using a Day-Light Classic Plus Light Therapy Lamp fitted with a LEE filter (#132, Medium Blue) and mounted on a healthcare-grade stand with rolling casters (Maclocks Rise Freedom Extended). The light intervention will be administered at bedside for 4 hours daily during the morning/early afternoon hours, repeated for up to 3 days.
• Устройство Bright Full-Spectrum (White) Light
  Bright full-spectrum (white) light will be administered using a Day-Light Classic Plus Light Therapy Lamp fitted with a LEE filter (#211 0.9 ND) and mounted on a healthcare-grade stand with rolling casters (Maclocks Rise Freedom Extended). The light intervention will be administered at bedside for 4 hours daily during the morning/early afternoon hours, repeated for up to 3 days.
• Устройство Usual Ambient Light
  Across all arms, the usual ambient light in the inpatient room will not be modified. For the Bright Blue Light and Bright Full-Spectrum (White) Light arms, light will be added to the environment using a Day-Light Classic Plus Light Therapy Lamp as specified in the corresponding intervention descriptions. For the Usual Ambient Light arm, a Day-Light Classic Plus Light Therapy Lamp mounted on a healthcare-grade stand with rolling casters (Maclocks Rise Freedom Extended) will be positioned at a 1

Первичные конечные точки

• Chest wall pain intensity, with incentive spirometer use [Срок оценки: Up to 72 hours (assessed twice daily)]

Вторичные конечные точки (10)

• Intensive care unit-free days [Срок оценки: 30 days]
• Rev-Erb alpha expression [Срок оценки: Up to 72 hours (blood samples collected daily)]
• IL-6 concentration [Срок оценки: Up to 72 hours (blood samples collected daily)]
• TNF-alpha concentration [Срок оценки: Up to 72 hours (blood samples collected daily)]
• IL-10 concentration [Срок оценки: Up to 72 hours (blood samples collected daily)]
• Opioid requirements [Срок оценки: Up to 72 hours (calculated daily)]
• Chest wall pain intensity, at rest [Срок оценки: Up to 72 hours (assessed twice daily)]
• Hospital-free days [Срок оценки: 30 days]
• Incidence of in-hospital delirium [Срок оценки: At 72 hours or date of discharge (assessed daily)]
• Incidence of pulmonary complications [Срок оценки: 30 days]

Критерии участия

Критерии включения

• Age greater than or equal to 18 years
• Admitted to a single large academic level I trauma center (Presbyterian/Montefiore hospital) within the first 48 hours of traumatic injury
• Greater than or equal to 1 acute rib fracture
• Pain related to rib fracture(s), by one or more of the following criteria: 1. Pain >/= 4/10 at rest, 2. Pain >/= 4/10 with incentive spirometer (IS) use, and/or 3. Inspiratory volume < 1000 cc
• Anticipated length of stay greater than or equal to 48 hours
• Alert, with capacity to provide informed consent

Критерии исключения

• Mechanical ventilation\* or non-invasive positive pressure ventilation administered for respiratory insufficiency prior to the time of informed consent
• Delirium (positive CAM screening) at the time of informed consent
• Ocular trauma, which may interfere with the mechanism of action
• Traumatic brain injury (TBI) or history of TBI or stroke, which may interfere with the mechanism of action
• Splenectomy upon admission or history of splenectomy, which may interfere with the mechanism of action
• History of significant ocular dysfunction\*\* (i.e., macular degeneration, glaucoma, cataracts), which may interfere with the mechanism of action
• History of cataract surgery, due to the possibility of blue light filtering intraocular lens placement
• History of bipolar disorder or schizophrenia, which could increase the risk of an adverse reaction to light exposure (i.e., acute mania)
• History of dementia, which would compromise the reliability of pain intensity and delirium measures

• Or other condition in which a patient cannot open eyes to receive light intervention or report a pain score \*\*Myopia, hyperopia, and/or astigmatism corrected for with contact lenses or spectacle corrective eyeglasses will NOT be a criterion for exclusion

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

США · 1 центр

• Presbyterian Hospital, University of Pittsburgh Medical Center — Pittsburgh

Публикации

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• Auriemma CL, Taylor SP, Harhay MO, Courtright KR, Halpern SD. Hospital-Free Days: A Pragmatic and Patient-centered Outcome for Trials among Critically and Seriously Ill Patients. Am J Respir Crit Care Med. 2021 Oct 15;204(8):902-909. doi: 10.1164/rccm.202104-1063PP. No abstract available. PMID 34319848
• Nielsen S, Degenhardt L, Hoban B, Gisev N. A synthesis of oral morphine equivalents (OME) for opioid utilisation studies. Pharmacoepidemiol Drug Saf. 2016 Jun;25(6):733-7. doi: 10.1002/pds.3945. Epub 2015 Dec 22. PMID 26693665
• Yuan D, Collage RD, Huang H, Zhang X, Kautza BC, Lewis AJ, Zuckerbraun BS, Tsung A, Angus DC, Rosengart MR. Blue light reduces organ injury from ischemia and reperfusion. Proc Natl Acad Sci U S A. 2016 May 10;113(19):5239-44. doi: 10.1073/pnas.1515296113. Epub 2016 Apr 25. PMID 27114521
• Lewis AJ, Zhang X, Griepentrog JE, Yuan D, Collage RD, Waltz PK, Angus DC, Zuckerbraun BS, Rosengart MR. Blue Light Enhances Bacterial Clearance and Reduces Organ Injury During Sepsis. Crit Care Med. 2018 Aug;46(8):e779-e787. doi: 10.1097/CCM.0000000000003190. PMID 29727369
• Griepentrog JE, Zhang X, Lewis AJ, Gianfrate G, Labiner HE, Zou B, Xiong Z, Lee JS, Rosengart MR. Frontline Science: Rev-Erbalpha links blue light with enhanced bacterial clearance and improved survival in murine Klebsiella pneumoniae pneumonia. J Leukoc Biol. 2020 Jan;107(1):11-25. doi: 10.1002/JLB.4HI0519-155R. Epub 2019 Aug 4. PMID 31379019
• Kotcher RE, Rosengart MR, La Colla L, Lin HS, Vogt KM, Xu Y, Neal MD. Blue Light as an Anti-inflammatory and Analgesic Strategy in Thoracic Trauma (BLAASTT): protocol for a randomised controlled trial in adult trauma inpatients with painful rib fractures. BMJ Open. 2025 Sep 5;15(9):e097462. doi: 10.1136/bmjopen-2024-097462. PMID 40912706

Идентификаторы

NCT: NCT06626334 · STUDY24040163 · T32GM075770

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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