Dynamic Point of Care Ultrasound (POCUS) Imaging Assessment of Diaphragmatic Function as a Predictor of Respiratory Failure and Clinical Outcomes in Patients With Septic Shock.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Number of participants Developing Respiratory Failure Requiring Invasive Mechanical Ventilation.
研究概览
简要总结
This prospective observational cohort study aims to evaluate the prognostic value of serial bedside ultrasound assessment of diaphragmatic function in adult patients with septic shock. Diaphragmatic excursion, thickness, and thickening fraction will be assessed using point of care ultrasound at baseline and serially during the first 72 hours of intensive care admission. Dynamic changes in these parameters will be analyzed in relation to the development of respiratory failure, need for invasive mechanical ventilation, duration of mechanical ventilation, weaning and extubation outcomes, length of ICU stay, and mortality. The study will determine whether dynamic diaphragmatic ultrasound assessment can provide an early, non-invasive predictor of respiratory failure and adverse clinical outcomes in patients with septic shock.
详细描述
Septic shock remains a major cause of morbidity and mortality among critically ill patients. Respiratory failure is a frequent and serious complication, resulting from a combination of sepsis-induced lung injury, acute respiratory distress syndrome, respiratory muscle dysfunction, and sepsis-induced myopathy. The diaphragm is the principal muscle of respiration and may be significantly affected during sepsis. Systemic inflammation, altered microcirculation, mitochondrial dysfunction, electrolyte abnormalities, prolonged immobilization, sedation, and mechanical ventilation can contribute to diaphragmatic dysfunction. Such dysfunction may impair spontaneous breathing, increase the risk of respiratory failure, prolong mechanical ventilation, and contribute to unsuccessful weaning and adverse clinical outcomes. Point-of-care ultrasound (POCUS) provides a non-invasive, bedside, radiation-free method for assessing diaphragmatic structure and function. The most commonly used parameters include diaphragmatic excursion (DE), diaphragmatic thickness, and diaphragmatic thickening fraction (DTF). Most available studies have assessed diaphragmatic function at a single point in time, particularly during weaning from mechanical ventilation. However, limited evidence exists regarding the prognostic value of serial dynamic assessment of diaphragmatic function in patients with septic shock from the early stages of ICU admission.
Dynamic changes in diaphragmatic function may provide more clinically meaningful information than a single measurement. Therefore, serial POCUS assessment may help identify patients at high risk of respiratory failure and predict important clinical outcomes.
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
- •Age ≥ 18 years old.
- •Patients with septic shock.
- •Patients with ICU admission during study period.
- •Expected ICU stay for at least 72 hours.
- •Informed consent from the patient or legal guardian when required.
排除标准
- •Age less than 18 years old.
- •Pre-existing neuromuscular disorders affecting respiratory muscles.
- •Known diaphragmatic paralysis or diaphragmatic palsy.
- •Significant phrenic nerve injury.
- •Cervical spinal cord injury.
- •Advanced chronic neuromuscular disease.
- •Previous major thoracic or diaphragmatic surgery.
- •Severe chest wall deformity.
- •Conditions preventing adequate diaphragmatic ultrasound assessment.
- •Pregnancy, if required by local ethical policy.
- •Patients with limitations of care that preclude full respiratory support.
- •Refusal of consent where consent is required.
研究组 & 干预措施
Patients with septic shock who are not receiving invasive mechanical ventilation at enrollment.
Patients with septic shock who are not receiving invasive mechanical ventilation at enrollment. primary respiratory outcome: Development of respiratory failure requiring invasive mechanical ventilation within 7 days after enrollment.
Patients with septic shock who are already receiving invasive mechanical ventilation at enrollment.
Patients with septic shock who are already receiving invasive mechanical ventilation at enrollment. outcomes: Duration of mechanical ventilation, weaning failure, extubation failure or reintubation, ICU and hospital mortality and ICU length of stay.
结局指标
主要结局
Number of participants Developing Respiratory Failure Requiring Invasive Mechanical Ventilation.
时间窗: From Baseline through Day 7
Number of participants who develop respiratory failure requiring initiation of invasive mechanical ventilation, assessed by clinical criteria and the requirement for endotracheal intubation and invasive mechanical ventilation.
Diaphragmatic Excursion Measured by Point of Care ultrasound
时间窗: Baseline, 24 hours, 48 hours, and 72 hours
Diaphragmatic Excursion measured using M mode point of care ultrasound during spontaneous breathing or ventilator supported breathing, as applicable and measured in millimeter. Three measurements will be obtained and averaged.
Diaphragmatic Thickness Measured by Point of Care Ultrasound
时间窗: Baseline, 24 hours, 48 hours, and 72 hours
Diaphragmatic thickness measured at the zone of apposition using B mode point of care ultrasound at end expiration and measured in millimeter. Three measurements will be obtained and averaged.
Diaphragmatic Thickening Fraction Measured by Point of Care Ultrasound
时间窗: Baseline, 24 hours, 48 hours, and 72 hours
Diaphragmatic thickening fraction measured using point of care ultrasound and calculated as \[(inspiratory thickness-expiratory thickness) / expiratory thickness\] \* 100 and measured in percentage. Three measurements will be obtained and averaged.
次要结局
- Time to Initiation of Invasive Mechanical Ventilation(From baseline through Day 7)
- Duration of invasive mechanical ventilation(From initiation of invasive mechanical ventilation until successful discontinuation of invasive mechanical ventilation, assessed through ICU discharge or up to 28 days, whichever comes first.)
- Number of Participants with Weaning failure(From the first spontaneous breathing trial until successful liberation from invasive mechanical ventilation or ICU discharge, assessed up to 28 days.)
- Number of Participants With Extubation failure(within 72 hours after extubation.)
- Duration of Intensive Care Unit stay(From baseline (ICU admission) until ICU discharge or death, assessed up to 28 days.)
- Number of Participants Who Die During Intensive Care Unit Stay(From baseline (ICU admission) until ICU discharge or death, assessed up to 28 days.)
研究者
Abdallah Gamal Abd El Hafeez Haridy
Internal Medicine Specialist
Assiut University