Ignite Creation Date:
2024-05-06 @ 8:23 PM
Last Modification Date:
2024-10-26 @ 3:26 PM
Study NCT ID:
NCT06361420
Status:
RECRUITING
Last Update Posted:
2024-04-11
First Post:
2024-03-10
Brief Title:
Driving Pressure-guided Lung Protective Ventilation
Sponsor:
Yong Lin PhD
Organization:
Fujian Medical University Union Hospital
Study Overview
Official Title:
The Efficacy of Driving Pressure-guided Lung Protective Ventilation in Surgical Repair of Acute Type A Aortic Dissection an Open-label Randomized Control Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-04
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:
DPV
Brief Summary:
The study named as The Efficacy of Driving Pressure-guided Lung Protective Ventilation in Surgical Repair of Acute Type A Aortic Dissection an open-label randomized control clinical trial aims to investigate whether driving pressure-guided lung protective ventilation can reduce postoperative oxygenation function in patients who have undergone surgical repair of acute type A aortic dissection The primary outcomes is the incidence of postoperative hypoxemia a partial pressure of arterial oxygen to inspiratory oxygen fraction ratio less than 300 mm Hg or a peripheral blood oxygen saturation less than 93 at any concentration of inspiratory oxygen within 7 days after the surgery
Detailed Description:
Postoperative hypoxemia is defined as a partial pressure of arterial oxygen to inspiratory oxygen fraction ratio less than 300 mm Hg or a peripheral blood oxygen saturation less than 93 at any concentration of inspiratory oxygen Acute type A aortic dissection is a lethal disease requiring emergency surgery Compared with non-cardiac surgery hypoxemia frequently occurs after surgical repair for acute type A aortic dissection which has been reported to be 52-676 and the possible mechanisms are as followed 1 systemic inflammatory reaction induced by massive thrombosis formation and long duration of extracorporeal circulation 2 ischemia-perfusion injury in lung and 3 a massive perioperative transfusion Postoperative hypoxemia has been reported to be associated with prolonged duration of extubation length of stay in ICU and respiratory failure which contributes a high mortality of 20 to 44
Driving pressure defined as the difference between platform airway pressure and positive end-expiratory pressure was first introduced by Amato and his colleagues in their meta-analysis study on acute respiratory distress syndrome in 2015 demonstrating that driving pressure was most strongly associated with survival among various ventilation parameters A lower driving pressure has been verified to be closely relative to an ameliorative prognosis after surgery However controversy persists regarding whether driving pressure-guided ventilation can decrease the incidences of postoperative hypoxemia and other pulmonary complications in the patients underwent surgical repair of acute type A aortic dissection
Given the need for additional evidence to confirm the relationship between driving pressure and postoperative hypoxemia in the patients with acute type A aortic dissection this open-label randomized control clinical trial aims to assess the efficacy and safety of the driving pressure-guided lung protective ventilation strategy in preventing hypoxemia and other pulmonary complications after the surgical repair for acute type A aortic dissection
Driving pressure defined as the difference between platform airway pressure and positive end-expiratory pressure was first introduced by Amato and his colleagues in their meta-analysis study on acute respiratory distress syndrome in 2015 demonstrating that driving pressure was most strongly associated with survival among various ventilation parameters A lower driving pressure has been verified to be closely relative to an ameliorative prognosis after surgery However controversy persists regarding whether driving pressure-guided ventilation can decrease the incidences of postoperative hypoxemia and other pulmonary complications in the patients underwent surgical repair of acute type A aortic dissection
Given the need for additional evidence to confirm the relationship between driving pressure and postoperative hypoxemia in the patients with acute type A aortic dissection this open-label randomized control clinical trial aims to assess the efficacy and safety of the driving pressure-guided lung protective ventilation strategy in preventing hypoxemia and other pulmonary complications after the surgical repair for acute type A aortic dissection
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