Mechanisms of Dynamic Airway Resistance Monitoring and Machine Learning for Assessing Pulmonary Inflammation and Guiding Sputum Suction in Mechanically Ventilated Patients
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 258
- 试验地点
- 3
- 主要终点
- The drop in airway viscous resistance before and after sputum suction
研究概览
简要总结
Research has shown that timely suctioning not only improves survival rates but also enhances the quality of life in ventilator-dependent patients. However, clinical judgment on the optimal timing for suctioning currently relies primarily on physician experience, lacking scientific evidence [10]. Airway viscous resistance reflects the frictional resistance encountered by gas flow within the airways and is closely associated with airway patency. When airway secretions increase, viscous resistance undergoes dynamic changes. Therefore, analyzing these dynamic variations in viscous resistance derived from ventilator waveforms to determine the optimal suctioning timing and assess its clinical impact on the progression of pulmonary inflammation holds significant scientific value and offers new insights and methodologies for clinical practice.
详细描述
To validate the clinical feasibility and reliability of airway viscous resistance monitoring, explore the temporal correlation between inflammatory biomarkers and changes in airway viscous resistance, establish a reference threshold system for special populations, and provide experimental evidence for determining the optimal suctioning timing.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 90 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinical diagnosis of Acute Respiratory Distress Syndrome (ARDS)
- •Clinical diagnosis of Acute Exacerbation of Chronic Obstructive Pulmonary Disease (AECOPD)
- •Clinical diagnosis of Severe pneumonia
排除标准
- •Clinical diagnosis of multiple organ failure;
- •Clinical diagnosis of multiple organ bleeding;
研究组 & 干预措施
Airway resistance-guided sputum suction
Investigators will continuously monitor the airway viscous resistance of patients, and initiate suctioning when the airway viscous resistance increases by ≥6 cmH₂O.
干预措施: The dynamics of airway resistance (Procedure)
Airway resistance-guided sputum suction
Investigators will continuously monitor the airway viscous resistance of patients, and initiate suctioning when the airway viscous resistance increases by ≥6 cmH₂O.
干预措施: conventional suctioning (Diagnostic Test)
conventional suctioning
In the control group, the decision to suction was made based on conventional clinical signs, including rhonchi and a rise in peak pressure.
结局指标
主要结局
The drop in airway viscous resistance before and after sputum suction
时间窗: the process of sputum aspiration(at most 30 minutes)
Airway viscous resistance drop (AVRD) is the primary efficacy endpoint of this study. It is defined as the difference in airway viscous resistance measured immediately before and after suctioning. Procedure: Record the ventilator-displayed viscous resistance value pre-suction; immediately after the maneuver, re-measure both viscous resistance and peak airway pressure with a high-precision pressure-time sensor. Calculation: The within-patient difference (pre minus post) is the AVRD. In a pilot study of nine patients, AVRD averaged 6.889 ± 3.551 cmH₂O, significantly larger than the concurrent peak-pressure drop (1.556 ± 1.740 cmH₂O), indicating that AVRD is more sensitive to the effect of suction on airway secretions. Clinical implication: AVRD can serve as a quantitative criterion for determining the optimal timing of endotracheal suction.
次要结局
- The number of participants with abnormal laboratory tests(Laboratory testing time ( at least 30 minutes))
- Sputum bacterial culture(3 days)