Evaluation of the Effect of Novel Recruitment Maneuver Therapy for Postoperative Pulmonary Atelectasis in the Patients With Cardiac Surgery
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
- 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.
- 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
- 否
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
研究组 & 干预措施
NEXAP group
The ventilator mode was changed from SIMV to PSV before LRM. After that, the abdominal pressure cardiopulmonary resuscitation (CPR-LW100) instrument was adopted and adsorbed on the epigastrium of patients. The LRM was performed by pulling up (tension of 20-30 kg) and compressing downward (tension<10 kg) alternately on the abdomen of the patients with a frequency of 12 times per minute to support and maintain breathing. The whole LRM procedure lasted for 3 minutes in total . After LRM, the ventilator mode was changed to its baseline settings.
干预措施: Negative extra-abdominal pressure (NEXAP)-based lung recruitment maneuver (Device)
PEEP group
The ventilator mode was changed from SIMV to PSV before LRM. After that, PEEP was increased gradually (every 3-5cmH2O per 30s) from baseline (5-8 cmH2O) to 20cmH2O. The PEEP level was maintained at 20cmH2O for 60s, followed by decrements to baseline PEEP (every 3-5cmH2O per 30s). After LRM, the ventilator was changed to the baseline settings.
干预措施: stepwise positive end-expiratory pressure (PEEP)-based lung recruitment maneuver (Other)
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
Jilai Xiao
associate chief physician
Nanjing First Hospital, Nanjing Medical University