跳至主要内容
临床试验/NCT06444854
NCT06444854招募中不适用

Patient Reported Outcomes Targeting Early Chest Tube Removal (PROTECTR) Study

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's2 个研究点 分布在 1 个国家目标入组 130 人开始时间: 2024年10月22日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
130
试验地点
2
主要终点
Rate of successful same day chest tube removal

研究概览

简要总结

This study is a single centre, prospective clinical trial evaluating the safety and feasibility of implementing a same day chest tube removal protocol in patients undergoing Video Assisted Thoracic Surgery (VATS) anatomical pulmonary surgery.

详细描述

Pulmonary resections are performed for a multitude of diagnostic and therapeutic reasons. The last decade has seen a rapid advancement of minimally invasive surgical (MIS) approaches which have resulted in improved patient outcomes. However, the post-operative care pathways have not evolved sufficiently to account for these changes. As such, many patients are still admitted after a minor lung resection for monitoring with a chest tube remaining in situ for a minimum of 24 hours. There have been a few retrospective cohort studies that demonstrate that patients do not experience significant complications during that 24-hour period that would warrant hospitalization. However, there have been no prospective controlled studies evaluating the safety and feasibility of early chest tube removal and discharge after a wedge resection. Furthermore, the maintenance of a large bore chest tube for an extended period is a cause for increased patient discomfort, increased narcotic use and may contribute to chronic pain secondary to intercostal nerve compression. As such, the prolonged chest tube maintenance and hospitalization may overall result in more patient harm than benefit.

Our group recently completed and presented a prospective safety and feasibility study demonstrating that chest tubes can be discontinued as early as 3 hours after minor MIS wedge resections of the lung with no adverse events. This study validated safety criteria that will be implemented moving forward. Furthermore, the maintenance of a large bore chest tube for an extended period is a cause for increased patient discomfort, increased narcotic use and may contribute to chronic pain secondary to intercostal nerve compression. As such, the prolonged chest tube maintenance and hospitalization may overall result in more patient harm than benefit. In the study mentioned previously, early chest tube removal led to 40% more patients being opioid free at post operative day 1 compared to those who underwent routine care.

Nevertheless, it is unclear if patients who undergo more extensive surgeries involving vascular dissection and longer operative times (i.e., pulmonary lobectomies and segmentectomies) will derive the same benefit. The incisions required to complete more complex operations are also larger compared to wedge resections. As such the pain associated with having a chest tube may or may not be as apparent in the setting of the larger incision. It is also unclear what the long-term impact of early chest tube removal has on quality of life in the perioperative period.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 18 yrs or older
  • scheduled to undergo elective VATS segmental or lobar resection of the lung

排除标准

  • Pulmonary function tests demonstrating forced expiratory volume in 1 second Forced Expiratory Volume (FEV1) <50% predicted, FEV1 <1.5L and/or diffusion lung capacity of carbon monoxide Lung Diffusion Test (DLCO) <50% predicted
  • Patient receives an intraoperative pleurodesis
  • Conversion to open thoracotomy or mini thoracotomy intraoperatively.
  • Underlying cognitive disorder resulting in inability to complete activities of daily living.

结局指标

主要结局

Rate of successful same day chest tube removal

时间窗: 30 days post-op

These patients have chest tube removed if they meet study criteria

EuroQol 5 Dimension 5 Level (EQ5D5L) score

时间窗: 30 days post-op

Difference in EQ5D5L scores between standard care and early chest tube removal on POD1 and POD30.

Mean Morphine Equivalents (MME) Post-Operative Day 1 (POD1)

时间窗: 24 hours

Mean Morphine Equivalents used on post operative day 1

Pleural reintervention

时间窗: 30 days post-op

Rate of pleural reintervention (defined as requiring reinsertion of a chest tube or return to the operating room)

次要结局

  • Complications(30 days post-op)
  • Chest Tube duration(30 days post-op)
  • Unplanned return(30 days post-op)
  • Length Of Stay(30 days post-op)

研究者

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

Rahul Nayak

Director of Research

London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

研究点 (2)

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