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

11 de septiembre de 2026 actualizado por: 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.

Descripción general del estudio

Descripción detallada

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.

Tipo de estudio

De observación

Inscripción (Estimado)

120

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Estudio Contacto

Copia de seguridad de contactos de estudio

Ubicaciones de estudio

      • Asyut, Egipto, 71515
        • Faculty of medicine, Assiut university

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

  • Adulto
  • Adulto Mayor

Acepta Voluntarios Saludables

No

Método de muestreo

Muestra no probabilística

Población de estudio

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.

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
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.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Number of participants Developing Respiratory Failure Requiring Invasive Mechanical Ventilation.
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Time to Initiation of Invasive Mechanical Ventilation
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Director de estudio: Refaat Fathy Abdelaal, professor, Assiut University
  • Director de estudio: Dina Ali Ahmed, doctor, Assiut University

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Estimado)

1 de octubre de 2026

Finalización primaria (Estimado)

15 de marzo de 2028

Finalización del estudio (Estimado)

1 de junio de 2028

Fechas de registro del estudio

Enviado por primera vez

4 de septiembre de 2026

Primero enviado que cumplió con los criterios de control de calidad

11 de septiembre de 2026

Publicado por primera vez (Actual)

15 de septiembre de 2026

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

15 de septiembre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

11 de septiembre de 2026

Última verificación

1 de septiembre de 2026

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

Sí

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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