NCT05714033已完成不适用
A Randomized Trial Comparing a Ventilatory Strategy To Prevent Atelectasis Versus a Lateral Decubitus Strategy During Robotic Bronchoscopy (VESPA vs. LADS Trial)
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 1
- 主要终点
- Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
研究概览
简要总结
To learn if LADS is better than VESPA at preventing atelectasis during a robotic bronchoscopy.
详细描述
Primary Objective:
To compare the proportion of patients developing target-obscuring atelectasis when using a lateral decubitus strategy (LADS) vs using a ventilatory strategy to prevent atelectasis (VESPA) during robotic bronchoscopy for posteriorly-located peripheral lung lesions.
Secondary Objectives:
- To compare the proportion of patients with atelectasis in the target lobe in VESPA vs. LADS during robotic bronchoscopy.
- To compare the proportion of patients with atelectasis obscuring 100%, 50% or more, and less than 50% of the target during robotic bronchoscopy using LADS vs. VESPA.
- To compare the proportion of patients in whom a biopsy sample was not taken due to atelectasis using LADS vs. VESPA.
- To compare the diagnostic yield using LADS vs. VESPA.
- To compare the proportion of tool in lesion (TIL) using LADS vs. VESPA.
- To compare the diagnostic accuracy (sensitivity and specificity) for malignancy using LADS vs. VESPA.
- To compare the proportion of LADS-induced vs. VESPA-induced complications.
- To compare the proportion of bronchoscopy-induced complications in LADS vs. VESPA.
- To compare the accuracy of 3D-2D image registration using LADS vs. VESPA.
- To compare clinical workflow in robotic bronchoscopy with VESPA and LADS strategies to identify potential improvements in workflow.
研究设计
- 研究类型
- 干预性
- 分配方式
- 随机
- 干预模型
- 单组
- 主要目的
- 诊断
- 盲法
- 开放（无盲法）
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 (≥ 18 years old) undergoing diagnostic robotic bronchoscopy for a lung nodule suspicious for malignancy bronchoscopy under general anesthesia.
- Lung nodules should be up to 3 cm in diameter and located in right or left bronchial segments B2, B6, B9, and B10. Greater than 50% of the volume of the lesion needs to be below a horizontal line traced at the most anterior edge of the corresponding vertebral body.
- Chest CT performed < 45 days prior to bronchoscopy.
- Voluntary informed consent to participate in the study.
排除标准
- Patients with prior lung consolidation, interstitial changes or lung masses (> 3 cm in diameter) as seen on most recent CT
- Lesions outside of the designated lung areas defined as inclusion criteria.
- Known pregnancy
- Vulnerable population
- Ascites
- Known diaphragmatic paralysis
- Smokers or ex-smokers with known or suspected severe air-trapping defined as residual volume > 150% of predicted
- History of primary or secondary spontaneous pneumothorax
- Lung bullae > 5 cm
- Patients with mediastinal or hilar adenopathy with high suspicion for malignancy in whom lymph node sampling is indicated and should occur prior to robotic bronchoscopy of the peripheral lesion.
- Patient with active COVID pneumonia.
研究组 & 干预措施
Group 1
Experimental
Group 1, Participants will receive VESAP during the bronchoscopy. Ventilatory Strategy To Prevent Atelectasis versus a Lateral Decubitus Strategy During Robotic Bronchoscopy
干预措施: Ventilatory Strategy To Prevent Atelectasis (Procedure)
Group 2
Experimental
Group 2, Participants will receive LADS Lateral Decubitus Strategy During Robotic Bronchoscopy during the bronchoscopy.
干预措施: Lateral Decubitus Strategy (LADS) (Procedure)
结局指标
主要结局
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
时间窗: through study completion; an average of 1 year.
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
标识符
- NCT 编号
- NCT05714033
- 其他研究编号
- 2022-0756, NCI-2023-00783
日期
- 首次提交
- (3年前)
- 首次发布
- (3年前)
- 主要完成日期
- (上个月)
- 研究完成日期
- (上个月)
- 最近核实
- (2个月前)
- 最近更新
- (上个月)
监管与共享
- FDA 监管药物
- 否
- FDA 监管器械
- 否
- 个体参与者数据共享计划
- 否
- 是否有结果
- 否
相似试验
招募中
不适用
同适应症 · 同分期Precision Lung Cancer Survivorship Care InterventionNeoplasms, PulmonaryCancer, LungCancers, PulmonaryCancers, LungPulmonary CancerCancer of the LungPulmonary NeoplasmNeoplasms, LungCancer, PulmonaryPulmonary CancersPulmonary NeoplasmsNeoplasm, PulmonaryCancer of LungLung CancersLung CancerNCT05857995Jerod L Stapleton, PhD300
已完成
不适用
同适应症 · 同分期Remote Monitoring of Lung Cancer Patient-Reported Outcomes Using Moovcare®Pulmonary CancerNeoplasms, PulmonaryNeoplasms, LungPulmonary NeoplasmsCancer of LungLung CancerNCT05011890UNC Lineberger Comprehensive Cancer Center41
Unknown
不适用
同适应症 · 同分期Clinical Utility for Ion Endoluminal SystemLung DiseasesPulmonary NoduleLung CancerNCT03893539Intuitive Surgical365
已完成
不适用
同适应症 · 同分期Lung Resection and Pulmonary RehabilitationPulmonary RehabilitationLung CancerNCT04722393Izmir Katip Celebi University66
终止
不适用
同适应症 · 同分期S0229, Pulmonary Rehabilitation Education w/wo Exercise Training in Improving Physical Function in Patients Who Are Undergoing Chemo & RT for Locally Advanced Lung CancerPulmonary ComplicationsLung CancerNCT00090961SWOG Cancer Research Network2