POCUS and Respiratory Failure Prognosis Based on Diaphragmatic Dysfunction

Sponsor

Azienda Ospedaliero-Universitaria di Modena (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05869045

Collaborator

(none)

432

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Respiratory Failure Diaphragm Disease	Other: Diaphragm shortening fraction measurement by point-of-care ultrasound.

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 Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

432 participants

Observational Model:

Cohort

Time Perspective:

Prospective

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

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Mar 1, 2024

Anticipated Study Completion Date :

May 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
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. 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%.	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.

Arm

Intervention/Treatment

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.

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%.

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

Outcome Measures

Primary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

Azienda Ospedaliero-Universitaria di Modena

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Carmine Cristiano Di Gioia, Attending physician, Azienda Ospedaliero-Universitaria di Modena

ClinicalTrials.gov Identifier:

NCT05869045

Other Study ID Numbers:

First Posted:

May 22, 2023

Last Update Posted:

May 22, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Carmine Cristiano Di Gioia, Attending physician, Azienda Ospedaliero-Universitaria di Modena

Point of care ultrasound

Diaphragm Disease

Additional relevant MeSH terms:

Respiratory Insufficiency

Study Results

No Results Posted as of May 22, 2023