POCUS and Respiratory Failure Prognosis Based on Diaphragmatic Dysfunction

Not yet recruiting

• Conditions: Respiratory Failure; Diaphragm Disease
• Interventions: Other: Diaphragm shortening fraction measurement by point-of-care ultrasound.

• Registration Number: NCT05869045
• Lead Sponsor: Azienda Ospedaliero-Universitaria di Modena

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.

Study Timeline

• Status Verified: 2023-05
• Study First Submitted: 2023-05-11
• Study First Submitted QC: 2023-05-11
• Last Update Submitted: 2023-05-11
• Study First Posted: 2023-05-22
• Last Update Posted: 2023-05-22
• Study Start: 2023-09-01
• Primary Completion: 2024-03-01
• Study Completion: 2024-05-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 432

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with Diaphragmatic dysfunction (DD)	Diaphragm shortening fraction measurement by point-of-care ultrasound.	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
Patients without Diaphragmatic dysfunction (DD)	Diaphragm shortening fraction measurement by point-of-care ultrasound.	Patients without diaphragmatic dysfunction measured by point-of-care ultrasound using the DSF method, which resulted in values higher than 10%.

Primary Outcome Measures

Name	Time	Method
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