Ignite Creation Date:
2024-05-06 @ 7:00 PM
Last Modification Date:
2024-10-26 @ 2:59 PM
Study NCT ID:
NCT05869045
Status:
NOT_YET_RECRUITING
Last Update Posted:
2023-05-22
First Post:
2023-05-11
Brief Title:
POCUS and Respiratory Failure Prognosis Based on Diaphragmatic Dysfunction
Sponsor:
Azienda Ospedaliero-Universitaria di Modena
Organization:
Azienda Ospedaliero-Universitaria di Modena
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2023-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None