Clinical trial NCT05869045: POCUS and Respiratory Failure Prognosis Based on Diaphragmatic Dysfunction
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
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Respiratory Failure
Diaphragm Disease
Keywords: Point of care ultrasound
Diaphragm Disease
Lead sponsor: Azienda Ospedaliero-Universitaria di Modena
Sponsor class: OTHER
First posted: 2023-05-22
Enrollment: 432
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients (≥18 years old) with respiratory failure who are admitted to the emergency department

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.

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.

Eligibility 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

Primary outcomes:
measure: Composite of mortality, intubation, or noninvasive ventilation failure within 30 days of admission
timeFrame: Patients will be followed up for a maximum of 1 months from admission to the emergency department, until discharge or death
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References: