Effects of AbClo Fascial Approximation Device in Patients With Open Abdomen on Respiratory Mechanics (AbClo-Resp)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Changes in End-expiratory Transpulmonary Pressure
研究概览
简要总结
Patients who underwent an abdominal surgery and had the abdomen remain open are called to have an "open abdomen". To limit the risk of further widening of their wounds, surgeons can use AbClo, which is a non-invasive abdominal binding device, to keep the abdominal wall together (i.e., approximate the fascia). However, as the device also compresses on the abdomen and adjacent lungs, this study aims:
- To assess whether the abdominal binding device causes changes in the pressure compressing the lungs, the lung volume, and the function of the lungs.
- To assess whether adjusting the breathing machine can mitigate such negative changes.
Participants will already be on the abdominal binding device when joining the study. Measurements on various aspects of the lung function (including its physical properties and capability to oxygenate the blood) will be done before and after adjustment of the abdominal binding device to the pressure (measured in the device itself) recommended by the manufacturer, as well as after the surgery to close the abdomen.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adult patients aged 18 years or older
- •Patients admitted to an ICU
- •Patients with postoperative abdominal surgery with open abdomen
- •Patients treated with AbClo device
- •Patients intubated and mechanically ventilated
- •Patients treated with intravenous sedation with a sedation-agitation scale score of 1-3
排除标准
- •Transient criteria: Patients with severe hemodynamic instability, defined systolic blood pressure less than 75 mmHg or mean arterial pressure less than 60 mmHg despite vasopressor use
- •Transient criteria: Patients with severe bleeding diathesis, defined as the latest platelet count less than 20 · 109/L, or the latest INR higher than 2.0
- •Patients with concurrent injuries to upper gastrointestinal tract that would preclude esophageal balloon insertion
- •Patients with bronchopleural fistula
- •Patients with measured and uncontrolled increased intracranial pressure
研究组 & 干预措施
Abdominal fascial approximation device
All patients are already on the device before starting the study
结局指标
主要结局
Changes in End-expiratory Transpulmonary Pressure
时间窗: On the day of enrolment and on the day of surgery to close the abdomen
Calculated by the difference between airway pressure and the value measured by an esophageal catheter at the end of expiration. Measurements are made once before the adjustment of the fascial approximation device to the optimal pressure, after the adjustment, and again after the surgery to close the abdomen.
次要结局
- Changes in Lung Volume(On the day of enrolment)
- Changes in oxygenation function(On the day of enrolment and on the day of surgery to close the abdomen)
- Response in End-expiratory Transpulmonary Pressure to PEEP Increase(On the day of enrolment)