Ventilatory Strategy to Prevent Atelectasis During Bronchoscopy Under General Anesthesia (VESPA Trial)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Presence or absence of atelectasis within each of the 6 bronchial segments
研究概览
简要总结
This trial compares two different types of ventilation for the prevention of partial or complete collapsed lung (atelectasis) in patients undergoing bronchoscopy under general anesthesia. Ventilatory strategy to prevent atelectasis (VESPA) may work better than standard of care mechanical ventilation to reduce the intra-procedural development of atelectasis during bronchoscopy under general anesthesia.
详细描述
PRIMARY OBJECTIVE:
I. To determine if our ventilatory strategy to prevent atelectasis (VESPA) can reduce the intra-procedural development of atelectasis during bronchoscopy under general anesthesia when compared with conventional mechanical ventilation.
SECONDARY OBJECTIVES:
I. To describe proportion of VESPA-induced complications. II. To describe and compare proportion of bronchoscopy-induced complications in VESPA and control arms.
OUTLINE: Patients are randomized to 1 of 2 groups.
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
- Single (Outcomes Assessor)
盲法说明
Image reviewers
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult patients undergoing bronchoscopy with radial probe endobronchial ultrasound (RP-EBUS) for peripheral lung lesions
- •Recent (< 4 weeks) chest computed tomography (CT) performed prior to the bronchoscopy
- •Voluntary informed consent to participate in the study
排除标准
- •Patients with baseline lung consolidation, interstitial changes or lung masses (> 3 cm in diameter) in dependent areas of the lung (right/left [R/L] B6, 9, or 10 bronchial segments) as seen on most recent CT
- •Pregnancy
- •Known diaphragmatic paralysis
- •Air-trapping with residual volume > 150% of predicted
- •History of primary or secondary spontaneous pneumothorax
- •Lung bullae > 5 cm
结局指标
主要结局
Presence or absence of atelectasis within each of the 6 bronchial segments
时间窗: During preoperative computed tomography (CT)
Will be determined using RP-EBUS. A segment will be identified as having a new atelectasis if there is an indication of solid- or semisolid-appearing lesion by RP-EBUS without a corresponding indication of solid tumor or atelectasis on the preoperative CT. If any of the two subsegments of any specific center has atelectasis, that segment will be considered atelectatic. The outcome of the reading will be defined by whatever pattern 2 or all 3 readers agree on. Locations of atelectasis will be summarized in a frequency table, allowing for multiple locations in the same patient. The proportion of segments identified as developing atelectasis among all evaluated segments will be calculated for each patient, and the distribution of the proportion will be summarized by the mean, median, and range.
Presence or absence of new atelectasis for each segment
时间窗: At the time of bronchoscopy
The proportion of patients identified as developing intraprocedural atelectasis by radial probe endobronchial ultrasound (RP-EBUS) and its 95% confidence interval will be estimated. The proportion of patients developing intraprocedural atelectasis will be compared between treatment and control arms, utilizing a 2-sided Chi-square test or Fisher's exact test to accomplish primary objective. Locations of atelectasis will be summarized in a frequency table, allowing for multiple locations in the same patient. The proportion of segments identified as developing atelectasis among all evaluated segments will be calculated for each patient, and the distribution of the proportion will be summarized by the mean, median, and range.
Presence or absence of atelectasis for each patient
时间窗: Up to 1 year
After identifying the presence or absence of new atelectasis for each segment, patients with at least 1 segment containing a new atelectasis will be determined to have atelectasis. Patients without atelectasis in any of the 6 segments will be determined to not have atelectasis. Patients with atelectasis and patients without atelectasis will be compared in terms of patient characteristics using a t-test or Wilcoxon test for continuous variables and Fisher's exact test or Chi-squared test for categorical variables.
次要结局
- Bronchoscopy-induced complications(Within 48 hours of bronchoscopy)
- Ventilatory strategy to prevent atelectasis (VESPA)-induced complications(Within 48 hours of bronchoscopy)