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NCT05869045 | Not yet recruiting | Respiratory Failure


POCUS and Respiratory Failure Prognosis Based on Diaphragmatic Dysfunction
Sponsor:

Modena University Hospital

Information provided by (Responsible Party):

Carmine Cristiano Di Gioia

Brief Summary:

This study aims to evaluate the use of POCUS to assess diaphragmatic function and its association with clinical outcomes in patients with respiratory failure who are admitted to the emergency department.

Condition or disease

Respiratory Failure

Diaphragm Disease

Intervention/treatment

Diaphragm shortening fraction measurement by point-of-care ultrasound.

Detailed Description:

Respiratory failure is a common condition that requires prompt diagnosis and treatment in the emergency department. Diaphragmatic dysfunction (DD) is a potential contributor to respiratory failure, but it is often underdiagnosed and undertreated. Point-of-care ultrasound (POCUS) is a non-invasive and feasible tool that can measure diaphragmatic function using parameters such as diaphragm excursion and diaphragm shortening fraction (DSF). However, the prognostic value of POCUS for DD in patients with respiratory failure is unclear. This study is a prospective observational cohort study that will enroll consecutive patients with respiratory failure who are admitted to the emergency department of a tertiary hospital. All patients will undergo POCUS examination of the diaphragm within 6 hours of admission by trained emergency physicians. The primary outcome will be the composite of mortality, intubation, or noninvasive ventilation failure within 30 days of admission. The secondary outcomes will include length of hospital stay, intensive care unit admission, and ventilator-free days. The association between POCUS parameters of diaphragmatic function and clinical outcomes will be analyzed using multivariate logistic regression and Cox proportional hazards models.}}

Study Type : Observational
Estimated Enrollment : 432 participants
Official Title : The Impact of Point-of-care Ultrasound (POCUS) on the Prognosis of Respiratory Failure in Patients Presenting to the Emergency Department Based on Diaphragmatic Dysfunction
Actual Study Start Date : September 1, 2023
Estimated Primary Completion Date : March 1, 2024
Estimated Study Completion Date : May 1, 2024

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: All
Accepts Healthy Volunteers: No
Criteria
Inclusion Criteria
  • Respiratory failure defined as one or more of the following: respiratory rate >24 breaths/min, oxygen saturation <90% on room air, PaO2/FiO2 ratio <300 mmHg, or need for supplemental oxygen
  • Ability to provide informed consent or availability of a legal representative
Exclusion Criteria
  • Pregnancy
  • History of thoracic surgery or trauma
  • Known neuromuscular disease affecting the diaphragm
  • Contraindications for POCUS examination such as chest wall deformity, subcutaneous emphysema, or skin infection

POCUS and Respiratory Failure Prognosis Based on Diaphragmatic Dysfunction

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POCUS and Respiratory Failure Prognosis Based on Diaphragmatic Dysfunction

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