Nebulized Heparin for Prevention of Acute Lung Injury in Adult Patients Suffering Smoke Inhalation Injury: a Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 88
- 试验地点
- 1
- 主要终点
- VFDs
研究概览
简要总结
This study aims to examine the effects of nebulized heparin on the clinical outcomes in adult patients suffering smoke inhalation injury.
Patients will be randomized to receive nebulized heparin or an equal volume of normal saline for 14 days and the incidence of acute lung injury will be compared in either group.
详细描述
Adult patients who suffered smoke inhalation injury and who are candidates for elective intubation, have evidence of bronchial burn by fiberoptic bronchoscopy, have no evidence of acute lung injury and no more than 24 hours since inhalation injury will be included.
Patients will be randomized into 2 groups:
Group A (Intervention): Patients will receive 5000 IU heparin mixed with 3 ml saline and nebulized every 4 hours until they are extubated or until 14 days have elapsed whichever is earlier.
Group B (Control): Patients will receive 4 ml of normal saline nebulized every 4 hours until they are extubated or until 14 days have elapsed whichever is earlier.
The primary end point is the VFDs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients indicated for elective intubation:
- •History of being trapped in a house or industrial fire.
- •Production of carbonaceous sputum.
- •Perioral facial burns affecting nose, lips, mouth, or throat .
- •Altered level of consciousness at any time after the incident and including confusion.
- •Symptoms of respiratory distress including a sense of suffocation, choking, breathlessness, and wheezing or discomfort affecting the eyes or throat, including irritation of the mucosal membranes.
- •Signs of respiratory distress including stertorous or labored breathing, and tachypnea or auscultatory abnormalities, including crepitations or rhonchi.
- •Hoarseness or loss of voice.
- •Evidence of bronchial burn by bronchoscopy to assess severity of inhalational trauma
- •NO injury: absence of carbonaceous deposits, erythema, oedema, brochorrhea, or obstruction.
- •Mild injury: minor patchy areas of erythema or carbonaceous deposits in proximal or distal bronchi.
- •Moderate injury: moderate degree of erythema, carbonaceous deposits, bronchorrhea, or bronchial obstructions.
- •Sever injury: sever inflammation with friability, copious carbonaceous deposits, bronchorrhea, or obstruction.
- •Massive injury: evidence of mucosal sloughing, necrosis or endoluminal obliteration.
- •No evidence of acute lung injury at presentation (either by radiology or ABG)
- •Radiological findings: Normal lung without increased interstitial markings, ground glass opacification, or consolidation.
- •ABG findings : PaO2/ Fio2 >
- •Time between inhalational injury and intubation not longer than 24 hours.
排除标准
- •Burn injury > 24 hours.
- •History of pulmonary diseases.
- •Pregnancy or breast feeding.
- •History of allergy to heparin or HIT.
- •History or laboratory evidence of coagulopathy.
- •Burns area > 50% of total body surface area. -
研究组 & 干预措施
Group A (Nebulized Heparin)
Heparin is nebulized via endotracheal tube
干预措施: Heparin (Drug)
Group B (Nebulized Saline)
Normal saline is nebulized via endotracheal tube
干预措施: Normal Saline (Other)
结局指标
主要结局
VFDs
时间窗: 28 days
Number of days free of mechanical ventilation
次要结局
- ICU-free days(28 days)
- Duration of mechanical ventilation(28 days)
- Mortality(28 days)
- Side effects(28 days)
- P/F ratio(14 days)
研究者
Sameh M. Hakim
Professor
Ain Shams University