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临床试验/NCT06682936
NCT06682936招募中不适用

Can Talc Pleurodesis for Malignant Pleural Effusion be Performed on an Ambulatory Basis

David Rollins1 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2024年1月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
15
试验地点
1
主要终点
Success rate of delivery of the ambulatory pleruodesis protocol

研究概览

简要总结

Patients with malignant pleural disease often experience a significant symptom burden and a short life expectancy. The cornerstone of their treatment is relieving breathlessness by draining fluid from around the lungs and attempting to prevent further fluid build up. Inpatient chest drainage and talc pleurodesis remains the most successful method of stopping the fluid build up but this often requires an average hospital stay of four days. This can be an inappropriate length of time for this patient group. Our study would investigate whether this treatment could be provided on an outpatient, ambulatory basis and facilitate a greater quality of life.

The investigators would assess deliverability of the trial protocol and collect patient feedback to see if our patients consider it an acceptable and worthwhile intervention.

详细描述

Eligible patients will be offered enrolment in the trial along with standard of care options.

Participants who agree to take part in the trial would be consented for chest drain, talc pleurodesis on an ambulatory pathway.

On day 1 a standard chest drain would be inserted in the morning and large volume fluid removal would commence using an underwater seal bottle- as per standard care. A chest x-ray would be undertaken to confirm drain position, as per standard care. The investigators would remove 1000mls of fluid (stopping earlier if not tolerated) and the clamp the drain for one hour. The investigators would then open the drain again and drain up to 500mls before again clamping for one hour. The investigators would repeat this process as frequently as possible until the end of the working day. The drain would then be connected to an ambulatory bag instead of the underwater seal bottle and left in the open position. The patient would then be sent home to return on day 2.

On day 2 the drain would be flushed, aspirated and the output assessed. If there is still fluid output the investigators would drain up to 500mls and close the drain for an hour and repeat. If there is no further output the investigators would undertake a chest x ray to ensure the effusion has resolved and the lung has fully inflated. If it has the investigators would proceed to talc slurry instillation (with 20mls 1% lidocaine as per standard practice) and clamp the drain for 2 hours. After this the investigators would open the drain again and drain up to 500mls and close the drain for an hour. The investigators would repeat this as required and again the patient would return home with an ambulatory bag left open.

If the effusion has resolved but the lung has not fully expanded due to underlying disease then the investigators would simply remove the chest drain as pleurodesis will not be possible.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
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
否

入选标准

  • •Malignant pleural effusion
  • •Life expectancy >30 days
  • •WHO PS 1-2 (3 if due to dyspnoea)

排除标准

  • •Previous failed pleurodesis (on affected side)
  • •Known non-expansile lung

研究组 & 干预措施

outpatient drain and talc pleurodesis

Experimental

Patients enrolled to the trial will have a chest drain inserted and we will aim to drain to dryness and instill medical grade talc as described in the protocol

干预措施: ambulatory chest drain and talc pleurodesis (Procedure)

结局指标

主要结局

Success rate of delivery of the ambulatory pleruodesis protocol

时间窗: 5 days

Can the investigators successfully deliver the described ambulatory pleruodesis protocol within the 5 day time frame and what is the success rate of the protocol delivery.

次要结局

  • Patient satisfaction / Patient related outcome measurement(30 days)
  • Patient satisfaction / Patient related outcome measurement(5 days)

研究者

发起方
David Rollins
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

David Rollins

Research governance manager - TVRA

North Tees and Hartlepool NHS Foundation Trust

研究点 (1)

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