Ignite Creation Date:
2024-05-06 @ 9:21 AM
Last Modification Date:
2024-10-26 @ 12:13 PM
Study NCT ID:
NCT02963025
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-03-07
First Post:
2016-11-10
Brief Title:
Protective Ventilation With High Versus Low PEEP During One-lung Ventilation for Thoracic Surgery
Sponsor:
Technische Universität Dresden
Organization:
Technische Universität Dresden
Study Overview
Official Title:
PROtective Ventilation With High Versus Low PEEP During One-lung Ventilation for THORacic Surgery PROTHOR A Randomized Controlled Trial
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:
None
Brief Summary:
One-lung ventilation OLV with resting of the contralateral lung may be required to allow or facilitate thoracic surgery However OLV can result in severe hypoxemia requiring a mechanical ventilation approach that is able to maintain adequate gas exchange while protecting the lungs against postoperative pulmonary complications PPCs During OLV the use of lower tidal volumes is helpful to avoid over-distension but can result in increased atelectasis and repetitive collapse-and-reopening of lung units particularly at low levels of positive end-expiratory pressure PEEP
Anesthesiologists inconsistently use PEEP and recruitment maneuvers RM in the hope that this may improve oxygenation and protect against PPC Up to now it is not known whether high levels of PEEP combined with RM are superior to lower PEEP without RM for protection against PPCs during OLV
Hypothesis An intra-operative ventilation strategy using higher levels of PEEP and recruitment maneuvers as compared to ventilation with lower levels of PEEP without recruitment maneuvers prevents postoperative pulmonary complications in patients undergoing thoracic surgery under standardized one-lung ventilation
Anesthesiologists inconsistently use PEEP and recruitment maneuvers RM in the hope that this may improve oxygenation and protect against PPC Up to now it is not known whether high levels of PEEP combined with RM are superior to lower PEEP without RM for protection against PPCs during OLV
Hypothesis An intra-operative ventilation strategy using higher levels of PEEP and recruitment maneuvers as compared to ventilation with lower levels of PEEP without recruitment maneuvers prevents postoperative pulmonary complications in patients undergoing thoracic surgery under standardized one-lung ventilation
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None