POCUS and Respiratory Failure Prognosis Based on Diaphragmatic Dysfunction

NCT ID: NCT05869045

Last Updated: 2023-05-22

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 432 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-09-01
• Study Completion Date: 2024-05-01

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.

Conditions

Respiratory Failure; Diaphragm Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Patients with Diaphragmatic dysfunction (DD)

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

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

Intervention Type: OTHER

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.

Patients without Diaphragmatic dysfunction (DD)

Patients without diaphragmatic dysfunction measured by point-of-care ultrasound using the DSF method, which resulted in values higher than 10%.

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

Intervention Type: OTHER

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.

Interventions

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.

Intervention Type: OTHER

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Azienda Ospedaliero-Universitaria di Modena

OTHER

Sponsor Role: lead

Responsible Party

Carmine Cristiano Di Gioia

Attending physician

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Carmine Cristiano Di Gioia

Role: CONTACT

cristianodigioia@icloud.com

+39 3493812503

Other Identifiers

DSF

Identifier Type: -

Identifier Source: org_study_id