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临床试验/NCT06049173
NCT06049173已完成不适用

Evaluation of the Effect of Novel Recruitment Maneuver Therapy for Postoperative Pulmonary Atelectasis in the Patients With Cardiac Surgery

Jilai Xiao1 个研究点 分布在 1 个国家目标入组 77 人开始时间: 2023年9月10日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
77
试验地点
1
主要终点
Lung ultrasound score (LUSS)

研究概览

简要总结

  1. Oxygenation index and bedside ultrasound would be used to evaluate the therapeutic effect of novel recruitment maneuver therapy in the patients with pulmonary atelectasis after cardiac surgery.
  2. To establish a new therapy strategy for pulmonary atelectasis after cardiac surgery and to evaluate its effectiveness and safety for the cardiac patients complicated with postoperative pulmonary atelectasis.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Factorial
主要目的
Treatment
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age ≥ 18 years
  • Underwent cardiac surgery with CPB
  • Patients with lung ultrasound evidence of atelectasis after surgery
  • Agree to participate in this study by themselves or their family member.

排除标准

  • Vasoactive-inotropic score (VIS)>20
  • Patients who were not suitable for using abdominal CPR compression-decompression instrument: bleeding from abdominal organs, abdominal aortic aneurysm, large abdominal tumor, intra-abdominal hypertension, etc
  • Hemothorax or large pleural effusion confirmed by ultrasonography/X-ray
  • Pneumothorax or air leak confirmed by ultrasonography/X-ray
  • Considered by other researchers to be unsuitable for participation in this study

结局指标

主要结局

Lung ultrasound score (LUSS)

时间窗: 5 min before treatment and 5 min after treatment

The thorax was divided by the anterior axillary line, the posterior axillary line, and a horizontal line beneath the nipple. The intercostal spaces of each of the 12 areas were scanned and analyzed . Aeration loss was assessed by calculating the modified lung ultrasound score (LUSS), which showed sufficient sensitivity to detect aeration loss. Two lung ultrasound examiners provided scores for each area after simultaneous examination of the lung scan. LUSS was then calculated globally (LUSStot, as the sum of the 12 regions score, ranging from 0 to 36), and regionally (LUSSp, posterior, LUSSa, anterior and LUSSl, lateral regions).

次要结局

未报告次要终点

研究者

发起方
Jilai Xiao
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Jilai Xiao

associate chief physician

Nanjing First Hospital, Nanjing Medical University

研究点 (1)

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