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临床试验/NCT03307018
NCT03307018招募中不适用

Assessment of Influence of Routine Postoperative Systematic Bronchial Aspiration With Flexible Bronchoscope on Occurrence of Pulmonary Complications After Anatomical Lung Resections: a Prospective Randomized Controlled Study.

Wielkopolskie Centrum Pulmonologii i Torakochirurgii2 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2021年4月8日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
2
主要终点
Atelectasis.

研究概览

简要总结

Respiratory complications are the largest group of complications following anatomical lung resections. Most of these complications result from a disrupted evacuation of respiratory secretions. At present, prevention of such complications involve: aspirating of secretions with a catheter during surgery through an intubation tube, active postoperative rehabilitation, mucolytic treatment and effective postoperative pain management. Suctioning of secretions by a catheter through an intubation tube does not, however, allow for removal of secretions from entire bronchial tree. Bronchofiberoscopy with a small-diameter flexible bronchoscope and thorough, systematic aspiration of secretions from respiratory tract immediately after surgery could presumably result in more effective bronchial cleansing and reduce risk of respiratory complications after surgery. Although the British Thoracic Society guidelines do not recommend routine bronchoscopy as a standard postoperative management after lung resections, they are based on a single, randomized, study analyzing a small group of patients. Bronchoscopy with systematic aspiration of secretions done with a thin flexible scope is a safe procedure, without risk of complications. It does not cause any additional discomfort to the patients and allows for much more accurate aspiration of the bronchial secretions than with a catheter inserted blindly through an intubation tube. It also gives an opportunity to directly evaluate segmental and subsegmental bronchial patency. This is particularly important in patients with COPD who tend to accumulate large amounts of mucus secretion in the bronchial tree.

详细描述

Introduction.

Atelectasis and pneumonia are the most common complications after anatomical lung resections. Their occurrence in the postoperative period may necessitate treatment with antibiotics and fiberoptic bronchoscopy and may lead prolongation of hospital stay, diminished quality of life and increased cost of treatment.

Among known risk factors, retention of bronchial secretions is probably the most important. Although at the end of surgery suctioning of the secretions from large airways is always done, it is usually performed with suction catheter inserted blindly through an endotracheal tube. This procedure does not allow for complete removal of secretions from all parts of bronchial tree and trachea. Remaining secretions may lead to postoperative atelectasis and pneumonia.

Fiberoptic bronchoscopy performed with a thin scope allows for accurate visual assessment and precise aspiration of secretions from all main, lobar and segmental bronchi. If performed in a systematic way, it allows for complete removal of bronchial secretions.

The role of routine bronchoscopic aspiration has already been evaluated in one randomized study. However, study group included only 20 subjects, which is too little to perform proper statistical analysis and draw conclusions (1).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Triple (Participant, Care Provider, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 89 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Pulmonary lobectomy.
  • Patients must be informed and must sign and give written informed consent.

排除标准

  • Wedge resection, segmentectomy, pneumonectomy.

结局指标

主要结局

Atelectasis.

时间窗: Up to 3 days after surgery.

Occurrence of atelectasis on chest X-ray.

次要结局

  • Atrial fibrillation.(Up to 3 days after surgery.)
  • Bronchial Secretion Retention Related Complications Score (BRCS).(Up to 3 days after surgery.)
  • CRP.(72 hours after the end of surgery.)

研究者

发起方
Wielkopolskie Centrum Pulmonologii i Torakochirurgii
申办方类型
Other
责任方
Sponsor

研究点 (2)

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