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临床试验/NCT03261479
NCT03261479终止不适用

Validation of Thermal Imaging to Detect Pneumonia

Massachusetts General Hospital1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2016年4月13日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
22
试验地点
1
主要终点
Presence of pneumonia

研究概览

简要总结

The investigators are proposing a two-stage, prospective, cohort study of 138 subjects > 28 days old and < 18 years old with respiratory distress, already getting a chest x-ray as part of their routine clinical care, who will get thermal pictures of their chest at the Massachusetts General Hospital (MGH) Emergency Department, Pediatric Wards, and Pediatric Intensive Care Unit. The thermal cameras will measure skin temperature, by taking a picture, in a non-contact way. The investigators will recruit 138 patients using the FLIR ONE thermal imaging camera for iPhone and the newly designed irPNA application. The FLIR ONE thermal imaging camera will be attached to a study-designated iPhone which will only have the ability to take pictures. This phone will not have the capability to make calls or use the internet. The iPhone will be password protected, as encrypted by Partners regulations. Demographic and diagnostic data will be collected from patient charts.

详细描述

I. BACKGROUND AND SIGNIFICANCE

  1. Historical Background

Every day 16,000 children under the age of 5-years die. Although strides have been made in early diagnosis and treatment of pneumonia, it still accounts for about 15% of deaths of children under 5-years (1). Unfortunately care providers in low- and middle-income countries (LMICs) are limited due to lack of resources and training. Chest x-rays are especially difficult to obtain in these LMICs (14). Ironically, smartphones are readily available. Since its development in 1960, Forward-Looking Infrared (FLIR) cameras have made several technological strides. Notably they are now more affordable and compact, attaching to smartphones. FLIR cameras now have the potential to aid in early diagnosis and subsequent treatment of childhood pneumonia.

FLIR imaging was first developed in 1956 with military funding at the University of Chicago. From the 1960s into the 1970s, FLIR technology was modified independently by both the Air Force and Texas Instruments Inc. for use by military planes (2). Wendell Smith first documented the use of thermal imaging in medical diagnosis in 1964. Smith required 6 minutes to take each thermograph of the horses he was studying (3). Multiple veterinary studies have been performed since then, and now thermal imaging has been validated as a means to assess musculoskeletal injuries in animals (4,5). 2. Previous Clinical Studies Supporting the Proposed Research

Interestingly, very few clinical studies have been performed to validate the use of thermal imaging in medical diagnosis for human diseases. The use of thermography to diagnose lung disease was studied in Russia in 1976, 1981, and 1991 in three separate studies, but these studies were neither controlled nor randomized (6-8). In 1970 Potanin demonstrated through a case series that patients with pneumonia had increased overlying chest temperatures and patients with pulmonary embolism had decreased overlying chest temperatures (12). The most recent and impactful study evaluating pneumonia with thermal imaging was a case series performed by Wiecek et al. (2001), which showed that patients with pneumonia demonstrated a reduction in thermographic signal as they positively responded to treatment (13). More modern studies have attempted to validate infrared thermal imaging in measuring the size of brain tumors intra-operatively (9), screening for fever in children (10), and predicting length of recuperation after burn injuries (11), among others. However, there has not been a modern study validating thermal imaging in diagnosing pneumonia. 3. Rationale behind Proposed Research and Potential Benefit to Society

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
28 Days 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • patients 28-days to 17-years of age
  • respiratory distress
  • receive a chest x-ray

排除标准

  • known chronic lung disease

结局指标

主要结局

Presence of pneumonia

时间窗: 1 year

Compare identification of pneumonia in thermal image to x-rays read by study radiologists

次要结局

  • Clinical diagnosis(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ryan Carroll

Assistant Pediatrician

Massachusetts General Hospital

研究点 (1)

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