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Dynamic POCUS of Diaphragm Function to Predict Respiratory Failure in Septic Shock (POCUS in RF)

2026年9月11日更新者：Abdallah Gamal Abd El Hafeez Haridy、Assiut University

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.

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.

研究概览

地位

尚未招聘

条件

详细说明

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.

研究类型

观察性的

注册 (估计的)

120

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

姓名：Abdallah Gamal Abd El Hafeez, Master
电话号码：+0201221248314
邮箱：abdallah.gamal0111@med.aun.edu.eg

研究联系人备份

姓名：Dina Ali Ahmed, MD
电话号码：+0201063040703
邮箱：dinaalihamad@aun.edu.eg

学习地点

埃及
- - Asyut、埃及、71515
    - Faculty of medicine, Assiut university

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

成人
年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

The study population will consist of adult patients 18 years old or more admitted to ICU with septic shock diagnosed according to the sepsis-3 criteria. Eligible patients will be prospectively enrolled after meeting the predefined inclusion and exclusion criteria and will undergo serial bedside point of care ultrasound assessment of diaphragmatic function during the first 72 hours of ICU admission.

描述

Inclusion Criteria:

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.

Exclusion Criteria:

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.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

团体/队列数

队列和干预

团体/队列
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.

研究衡量的是什么？

主要结果指标

结果测量	措施说明	大体时间
Number of participants Developing Respiratory Failure Requiring Invasive Mechanical Ventilation. 大体时间：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.	From Baseline through Day 7
Diaphragmatic Excursion Measured by Point of Care ultrasound 大体时间：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.	Baseline, 24 hours, 48 hours, and 72 hours
Diaphragmatic Thickness Measured by Point of Care Ultrasound 大体时间：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.	Baseline, 24 hours, 48 hours, and 72 hours
Diaphragmatic Thickening Fraction Measured by Point of Care Ultrasound 大体时间：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.	Baseline, 24 hours, 48 hours, and 72 hours

次要结果测量

结果测量	措施说明	大体时间
Time to Initiation of Invasive Mechanical Ventilation 大体时间：From baseline through Day 7	Time from study enrollment to initiation of invasive mechanical ventilation, measured in hours	From baseline through Day 7
Duration of invasive mechanical ventilation 大体时间：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.	Duration of invasive mechanical ventilation, calculated from the initiation of invasive mechanical ventilation until successful discontinuation of mechanical ventilation, measured in days.	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 大体时间：From the first spontaneous breathing trial until successful liberation from invasive mechanical ventilation or ICU discharge, assessed up to 28 days.	Number of participants who fail the initial attempt to discontinue invasive mechanical ventilation according to predefined clinical criteria and subsequently require continuation or resumption of mechanical ventilatory support.	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 大体时间：within 72 hours after extubation.	Number of participants requiring reintubation and reinstitution of invasive mechanical ventilation following planned extubation.	within 72 hours after extubation.
Duration of Intensive Care Unit stay 大体时间：From baseline (ICU admission) until ICU discharge or death, assessed up to 28 days.	Duration of stay in the intensive care unit from ICU admission until ICU discharge, measured in days.	From baseline (ICU admission) until ICU discharge or death, assessed up to 28 days.
Number of Participants Who Die During Intensive Care Unit Stay 大体时间：From baseline (ICU admission) until ICU discharge or death, assessed up to 28 days.	Number of participants who die during the Intensive Care Unit stay	From baseline (ICU admission) until ICU discharge or death, assessed up to 28 days.

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Assiut University

调查人员

研究主任：Refaat Fathy Abdelaal, professor、Assiut University
研究主任：Dina Ali Ahmed, doctor、Assiut University

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年10月1日

初级完成 (估计的)

2028年3月15日

研究完成 (估计的)

2028年6月1日

研究注册日期

首次提交

2026年9月4日

首先提交符合 QC 标准的

2026年9月11日

首次发布 (实际的)

2026年9月15日

研究记录更新

最后更新发布 (实际的)