Ignite Creation Date:
2024-06-16 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06438198
Status:
RECRUITING
Last Update Posted:
2024-05-31
First Post:
2024-05-14
Brief Title:
Early Switch from Controlled to Assisted Ventilation
Sponsor:
Erasmus Medical Center
Organization:
Erasmus Medical Center
Study Overview
Official Title:
Unraveling the pathophysiological Mechanisms and Potential Clinical Benefits of an Early Switch from Controlled to Assisted Ventilation
Status:
RECRUITING
Status Verified Date:
2024-10
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:
SWITCH-SAFE
Brief Summary:
The goal of this physiological intervention study is to unravel the pathophysiological mechanisms and potential clinical benefits of a pre-specified early switch from controlled to assisted ventilation in mechanically ventilated adult patients with acute hypoxemic respiratory failure PaO2FiO2 ratio 200 mmHg
The intervention is that participants will be switched from controlled to assisted ventilation when PaO2FiO2 ratio 200 mmHg
The primary endpoint is the change in regional lung stress as derived by electrical impedance tomography when switching from controlled to assisted ventilation and until a successful or failed switch
The intervention is that participants will be switched from controlled to assisted ventilation when PaO2FiO2 ratio 200 mmHg
The primary endpoint is the change in regional lung stress as derived by electrical impedance tomography when switching from controlled to assisted ventilation and until a successful or failed switch
Detailed Description:
A crucial milestone in the trajectory of the mechanically ventilated patient is the switch from fully controlled mechanical ventilation to assisted ventilation This switch should be made as early as feasible and safe to limit the detrimental effects from prolonged controlled ventilation and sedation However there is also indirect evidence that excessive breathing effort during assisted ventilation may worsen lung injury P-SILI There are no guidelines that address this important switch moment
Therefore the overall aim of this physiological intervention study is to unravel the pathophysiological mechanisms and potential clinical benefits of a pre-specified early switch from controlled to assisted ventilation in mechanically ventilated adult patients with acute hypoxemic respiratory failure PaO2FiO2 ratio 200 mmHg
Participants will be switched from controlled to assisted ventilation switch when PaO2FiO2 ratio 200 mmHg and will be monitored continuously using electrical impedance tomography and oesophageal and gastric pressure until 4 hours post-switch and twice daily for 72 hours or until switch failure switch back to controlled ventilation within 72 hours
The primary endpoint is the change in regional lung stress as derived by electrical impedance tomography when switching from controlled to assisted ventilation and until a successful or failed switch
Therefore the overall aim of this physiological intervention study is to unravel the pathophysiological mechanisms and potential clinical benefits of a pre-specified early switch from controlled to assisted ventilation in mechanically ventilated adult patients with acute hypoxemic respiratory failure PaO2FiO2 ratio 200 mmHg
Participants will be switched from controlled to assisted ventilation switch when PaO2FiO2 ratio 200 mmHg and will be monitored continuously using electrical impedance tomography and oesophageal and gastric pressure until 4 hours post-switch and twice daily for 72 hours or until switch failure switch back to controlled ventilation within 72 hours
The primary endpoint is the change in regional lung stress as derived by electrical impedance tomography when switching from controlled to assisted ventilation and until a successful or failed switch
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