POCUS and Respiratory Failure Prognosis Based on Diaphragmatic Dysfunction

Respiratory Failure Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05869045
• Other study ID #: DSF
• Status: Not yet recruiting
• 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
• 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

Related Conditions & MeSH terms

• Diaphragm Disease
• Respiratory Failure
• Respiratory Insufficiency

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