Ignite Creation Date:
2024-05-06 @ 3:08 PM
Last Modification Date:
2024-10-26 @ 1:43 PM
Study NCT ID:
NCT04534933
Status:
COMPLETED
Last Update Posted:
2022-02-17
First Post:
2020-08-13
Brief Title:
Flow Controlled Ventilation in Thoracic Surgery
Sponsor:
Medical University Innsbruck
Organization:
Medical University Innsbruck
Study Overview
Official Title:
Flow Controlled Ventilation Versus Pressure Controlled Ventilation in Thoracic Surgery With One Lung Ventilation - a Prospective Randomized Clinical Study
Status:
COMPLETED
Status Verified Date:
2020-02
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 trial investigates effects of individualized by compliance guided pressure settings flow-controlled ventilation compared to best clinical practice pressure-controlled ventilation in thoracic surgery requiring one lung ventilation
Detailed Description:
Flow-controlled ventilation FCV is a novel ventilation method with promising first results in porcine studies as well as clinical trials A more efficient and maybe lung protective ventilation strategy would be crucial in the challenging situation of one lung ventilation during thoracic surgery when the whole gas exchange has to be provided by just one half of the lungs It could not only improve respiratory values but also decrease the incidence of postoperative pulmonary complications which is a major cause of death after thoracic surgery
Thus individualized FCV based on compliance guided pressure settings will be compared to best clinical practice pressure-controlled ventilation in thoracic surgery requiring one lung ventilation in a randomized controlled trial Based on a previous preclinical trial improved oxygenation will be expected and thus arterial partial pressure of oxygen pO2 is the main primary outcome parameter of this study Furthermore improved recruitment of lung tissue due to controlled expiratory flow in FCV will be anticipated without the need of recruitment maneuvers which may cause deleterious effects on lung tissue
Thus individualized FCV based on compliance guided pressure settings will be compared to best clinical practice pressure-controlled ventilation in thoracic surgery requiring one lung ventilation in a randomized controlled trial Based on a previous preclinical trial improved oxygenation will be expected and thus arterial partial pressure of oxygen pO2 is the main primary outcome parameter of this study Furthermore improved recruitment of lung tissue due to controlled expiratory flow in FCV will be anticipated without the need of recruitment maneuvers which may cause deleterious effects on lung tissue
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