Ignite Creation Date:
2024-05-06 @ 7:21 PM
Last Modification Date:
2024-10-26 @ 3:05 PM
Study NCT ID:
NCT05989139
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-15
First Post:
2023-06-22
Brief Title:
HF vs NIV in Acute Cardiogenic Pulmonary Edema
Sponsor:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Organization:
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Study Overview
Official Title:
Non-Invasive Ventilation And Right Ventricle Function In Cardiogenic Pulmonary Edema An Echocardiographic Perspective To Select The Appropriate Ventilatory Support
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-03
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:
HFvsNIV
Brief Summary:
The studys primary aim is
to compare the effects of two different ventilation modalities non-invasive positive-pressure ventilation NPPV and high-flow nasal cannulae HFNC in the acute cardiogenic pulmonary edema ACPE setting in terms of echocardiographic parameters of RV systolic and RV strain
to determine the differences of the two interventions on other hemodynamic parameters echocardiographically assessed
to assess the differences between the two interventions on physiological parameters ie mean arterial pressure MAP heart rate HR respiratory rate RR oxygen saturation SpO2 and on arterial blood gases ABG analysis parameters ie relief of dyspnea and respiratory distress patient comfort
Enrolled patients will receive NPPV and HFNC oxygen therapy in a randomized cross-over fashion for 40 minutes each time 0 T0 and time 1 T1 followed by clinical and echocardiographic evaluation
to compare the effects of two different ventilation modalities non-invasive positive-pressure ventilation NPPV and high-flow nasal cannulae HFNC in the acute cardiogenic pulmonary edema ACPE setting in terms of echocardiographic parameters of RV systolic and RV strain
to determine the differences of the two interventions on other hemodynamic parameters echocardiographically assessed
to assess the differences between the two interventions on physiological parameters ie mean arterial pressure MAP heart rate HR respiratory rate RR oxygen saturation SpO2 and on arterial blood gases ABG analysis parameters ie relief of dyspnea and respiratory distress patient comfort
Enrolled patients will receive NPPV and HFNC oxygen therapy in a randomized cross-over fashion for 40 minutes each time 0 T0 and time 1 T1 followed by clinical and echocardiographic evaluation
Detailed Description:
None
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