Ignite Creation Date:
2024-05-05 @ 5:00 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00364741
Status:
COMPLETED
Last Update Posted:
2009-10-16
First Post:
2006-08-15
Brief Title:
Supplemental Oxygen and Complications After Abdominal Surgery The PROXI-trial
Sponsor:
Rigshospitalet Denmark
Organization:
Rigshospitalet Denmark
Study Overview
Official Title:
PeRioperative OXygen Fraction - Effect on Surgical Site Infection and Pulmonary Complications After Abdominal Surgery The PROXI-trial
Status:
COMPLETED
Status Verified Date:
2009-10
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:
None
Brief Summary:
Aim To investigate the effect of high intra- and postoperative oxygen concentration 80 as opposed to normally 30 on surgical wound infection and pulmonary complications after abdominal surgery
Background Surgical wound infection is a common and serious complication Tissue oxygen tension is often low after surgery and the resistance against infection depends on this factor through bacterial killing by neutrophils Oxygen is a substrate in this reaction and it is hypothesized that by increasing the arterial oxygen tension the risk of surgical wound infection is reduced Previous studies to test this hypothesis have shown entirely different results Hence the clinical decision between high and normal oxygen concentration is still controversial
Primary hypothesis of study Use of 80 oxygen decreases the incidence of surgical wound infection after abdominal surgery
Secondary objectives To investigate the effect 80 oxygen on pulmonary complications atelectasis pneumonia respiratory insufficiency second operation mortality and length of postoperative hospitalization and admission to intensive care unit after abdominal surgery
Background Surgical wound infection is a common and serious complication Tissue oxygen tension is often low after surgery and the resistance against infection depends on this factor through bacterial killing by neutrophils Oxygen is a substrate in this reaction and it is hypothesized that by increasing the arterial oxygen tension the risk of surgical wound infection is reduced Previous studies to test this hypothesis have shown entirely different results Hence the clinical decision between high and normal oxygen concentration is still controversial
Primary hypothesis of study Use of 80 oxygen decreases the incidence of surgical wound infection after abdominal surgery
Secondary objectives To investigate the effect 80 oxygen on pulmonary complications atelectasis pneumonia respiratory insufficiency second operation mortality and length of postoperative hospitalization and admission to intensive care unit after abdominal surgery
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| KF 02 306766 | None | None | None |
| GCP-2006-101 | None | None | None |