POCUS and Respiratory Failure Prognosis Based on Diaphragmatic Dysfunction

NCT05869045 | Unknown

• 1 other identifier: DSF
• Study Type: observational
• Target: 432
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Respiratory Failure; Diaphragm Disease

Keywords

Point of care ultrasound; Diaphragm Disease

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

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

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%.

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

Interventions

Diaphragm shortening fraction measurement by point-of-care ultrasound. 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 with Diaphragmatic dysfunction (DD); Patients without Diaphragmatic dysfunction (DD)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients (≥18 years old) with respiratory failure who are admitted to the emergency department

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Azienda Ospedaliero-Universitaria di Modena: lead

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Central Study Contacts

Carmine Cristiano Di Gioia

CONTACT

+39 3493812503; cristianodigioia@icloud.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 30 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician

Study Record Dates

• First Submitted: May 11, 2023
• First Posted: May 22, 2023
• Study Start: September 1, 2023
• Primary Completion: March 1, 2024
• Study Completion: May 1, 2024
• Last Updated: May 22, 2023

Record last verified: 2023-05