An observational study in Respiratory Failure and Diaphragm Disease, sponsored by Azienda Ospedaliero-Universitaria di Modena. Not yet recruiting. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2023-05-22.
Sponsored by Azienda Ospedaliero-Universitaria di Modena · Observational
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.
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.
1,650 studies on the registry are indexed under Respiratory Insufficiency; 296 are open to participants now.
This study's planned enrollment of 432 is above the median of 100 across 545 observational studies indexed under Respiratory Insufficiency.
Browse Respiratory Insufficiency studies →Azienda Ospedaliero-Universitaria di Modena is the lead sponsor of 46 studies on the registry; 19 are open to participants now.
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Adult patients (≥18 years old) with respiratory failure who are admitted to the emergency department
Exclusion Criteria:
Patients with diaphragmatic dysfunction measured by point-of-care ultrasound using the diaphragm shortening fraction (DSF) method, which resulted in values lower than 10%. DSF is calculated by the formula: diaphragmatic thickness at the end of inspiration - diaphragmatic thickness at the end of expiration/diaphragmatic thickness at the end of expiration×100
Other: Diaphragm shortening fraction measurement by point-of-care ultrasound.
Patients without diaphragmatic dysfunction measured by point-of-care ultrasound using the DSF method, which resulted in values higher than 10%.
Other: Diaphragm shortening fraction measurement by point-of-care ultrasound.
A noninvasive and feasible method to assess diaphragmatic function and predict the prognosis of patients with respiratory failure presenting to the emergency department. The method consists of measuring the diaphragmatic thickness at the end of inspiration and expiration using a linear probe placed in the subcostal region and calculating the percentage of change using the formula: diaphragmatic thickness at the end of inspiration - diaphragmatic thickness at the end of expiration/diaphragmatic thickness at the end of expiration×100. A value lower than 10% indicates diaphragmatic dysfunction and a higher risk of adverse outcomes.
Composite of mortality, intubation, or noninvasive ventilation failure within 30 days of admission
Time frame: Patients will be followed up for a maximum of 1 months from admission to the emergency department, until discharge or death
No study locations are listed for this record.
Plan to share: Undecided
No publications or documents are linked to this record.
This study is not yet recruiting, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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Azienda Ospedaliero-Universitaria di Modena