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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT05869045
Other study ID # DSF
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date September 1, 2023
Est. completion date May 1, 2024

Study information

Verified date May 2023
Source Azienda Ospedaliero-Universitaria di Modena
Contact Carmine Cristiano Di Gioia
Phone +39 3493812503
Email cristianodigioia@icloud.com
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 432
Est. completion date May 1, 2024
Est. primary completion date March 1, 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

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.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Azienda Ospedaliero-Universitaria di Modena

Outcome

Type Measure Description Time frame Safety issue
Primary Composite of mortality, intubation, or noninvasive ventilation failure within 30 days of admission Patients will be followed up for a maximum of 1 months from admission to the emergency department, until discharge or death
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