Incidence of Acute Laryngeal Injury Following Endotracheal Intubation
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- Acute Laryngeal Injury
研究概览
简要总结
The purpose of this investigation is to delineate the incidence of acute and chronic laryngeal injury following intubation within our health system. In addition, this study seeks to identify risk factors for airway injury that may provide information to help reduce the incidence of injury or increase the speed of diagnosis through hospital based process measures.
Study Aims
- Determine the incidence of acute laryngeal injury in patients with prolonged intubation.
- Determine the incidence of chronic laryngeal injury in the subset of patients with acute laryngeal injury
- Initiate a randomized control trial to investigate the ability of azithromycin and budesonide to improve objective and subjective breathing measures in patients with Acute Laryngeal injury (ALgI) following endotracheal intubation.
详细描述
In the United States, 55 000 patients receive care in more than 6 000 intensive care units (ICUs) each day. The most common reason for ICU admission is respiratory failure and the need for a mechanical ventilator. Although 50% to 70% of patients survive their acute illness, the remainder are left with massive impairments in health and overall functioning. One of the most severe post-ICU complications is airway scaring directly resulting from endotracheal intubation.
Scarring of the vocal cords or trachea after intubation results from mucosal injury by an endotracheal tube (i.e. breathing tube). The initial mucosal injury ultimately heals with pathologic fibrotic contracture. This fibrosis physiologically restricts ventilation, and produces life-threatening dyspnea and airway obstruction. Acute and chronic airway injury following intubation is largely unappreciated owing to the fact that the long-term sequelae of intensive respiratory support is rarely managed by practitioners providing acute care. Treatments for chronic airway injury are suboptimal. They are largely surgical and offer marginal improvement in breathing while causing permanently worsened voice. Preventative efforts to preserve laryngeal and tracheal function (through identification of modifiable risk factors) could reduce the incidence of this devastating complication of medical care. Additionally, early identification of acute laryngeal injury after intubation may prevent the development of chronic complications. Patients with acute post-intubation airway injury treated with early endoscopic surgery require significantly fewer procedures, and may avoid an invasive open surgical reconstruction compared with patients treated with chronic fibrotic scars.
The development of airway fibrosis and ventilatory obstruction has been linked to inflammatory processes. Macrolide antibiotics such as azithromycin has been shown to reduce mucosal airway inflammation. IN addition the combination of a macrolide antibiotic and budesonide an inhaled corticosteroid has been shown to work synergistically to reduce inflammation and modify the disease process of tracheal stenosis in rabbit models.
The purpose of this investigation is to delineate the incidence of acute and chronic laryngeal injury following intubation within our health system. In addition, this study seeks to identify risk factors for airway injury that may provide information to help reduce the incidence of injury or increase the speed of diagnosis through hospital based process measures. Finally, in patients with acute laryngeal injury, this study seeks to investigate the effects of azithromycin and budesonide to improve objective and subjective breathing measures in patients with Acute Laryngeal injury (ALgI) following endotracheal intubation.
Overview: Patients will be recruited from adult patients in the surgical and medical intensive care units of Vanderbilt Medical Center who were intubated for greater than 48 hours. Following informed consent and study enrolment, data will be stored in a secure REDCap database housed within a server located behind the Vanderbilt University Medical Center (VUMC) firewall. Data analysis will be performed by KSP at VUMC.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Investigator)
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
- •English-speaking
- •Greater than 24 hours and less than 7 days of intubation in the intensive care unit
排除标准
- •Age under 18 years on admission
- •Patients with anticipated discharge 5 days after extubation
- •Patients who are dependent for activities of daily living (ADLs) in the 30 days prior to admission
- •Patients unable to consent
- •Patients with neck trauma
- •Patients with head and neck malignancies
- •Patients with pre-existing laryngeal or tracheal stenosis
- •Patients with other pre-existing respiratory conditions such as chronic obstructive pulmonary disease (COPD), asthma, neuromuscular dystrophies, cystic fibrosis, bronchiectasis
- •Patients who had been previously intubated for an extended period of time
- •Patients who are pregnant or currently breastfeeding
- •Patients with allergies to study medications
- •Patients with a resting heart rate greater than 100 beats per minute
- •Patients with a prolonged corrected QT (QTc) interval (>450 msec) or the use of medications that prolong the QTc interval or are associated with Torsades de pointes (with the exception of amiodarone)24
- •Patients with severe hearing impairment documented by audiometric testing
研究组 & 干预措施
Medical Therapy
medical therapy group consisting of azithromycin 250 mg and budesonide 0.5 mg for 14 days
干预措施: Budesonide and Azithromycin (Drug)
Placebo Control
Placebo control medication for 14 days
干预措施: Placebo control of budesonide and azithromycin (Other)
结局指标
主要结局
Acute Laryngeal Injury
时间窗: Within 72 hours of extubation
Endoscopic examination with evidence of laryngeal injury
Chronic Obstructive Pulmonary Disease Dyspnea Questionnaire (CCQ)
时间窗: 12 week follow up
12 week patient-reported dyspnea via CCQ. Total score is recorded, with a range of 0-60 with higher values representing worse outcomes.
次要结局
- Chronic Laryngeal Injury(8-12 weeks after sustaining acute laryngeal injury)
研究者
Alexander Gelbard, MD
Assistant Professor
Vanderbilt University Medical Center
