Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2025-12-17 @ 5:50 PM
Study NCT ID:
NCT06321874
Status:
None
Last Update Posted:
2024-04-10 00:00:00
First Post:
2024-02-22 00:00:00
Brief Title:
Effects of Oxygen After Abdominal Oncological Surgery
Sponsor:
Jules Bordet Institute
Organization:
Jules Bordet Institute
Study Overview
Official Title:
Exploring Postoperative Effects of Hyperoxic Intermittent Stimuli on Reticulocytes Levels in Abdominal Surgery: A Randomized Single-blind Study
Status:
None
Status Verified Date:
2024-02
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:
EPHIRAS
Brief Summary:
For anemia treatment in cancer patients, human recombinant erythropoietin is often used. However, its application is constrained due to high costs, side effects, and limited availability in some regions. This research and clinical exploration aim to identify an tool alternative to transfusion.
Randomization was conducted post-surgery in a 1:1 ratio across groups: Normobaric Oxygen Paradox (NOP) group, and a control (CTR) group. The NOP group received 60% oxygen for two hours on days 1, 3, and 5 post-surgery using a venti-mask. The CTR group did not receive oxygen therapy during the post-operatory period starting from day 1. All patients could receive oxygen during the surgery and the first 24 hours post-surgery (day 0) as needed. The belonging to one group or the other was blinded to the laboratory staff.
Pre-surgery, all patients were administered an oral benzodiazepine. General anesthesia was employed, potentially combined with epidural techniques and standard anesthesia monitors were used. The choice of anesthesia technique was at the discretion of the anesthetist. During surgery, patients received 40-50% FiO2 ventilation and were extubated at the surgery's end. Post-surgery, patients were admitted to the ICU for at least 24 hours, receiving oxygen if saturation dropped below 98%. The oxygen protocol commenced 24 hours after ICU admission (day 1). The transfusion threshold was set at 8 g/dl with clinical signs.
Randomization was conducted post-surgery in a 1:1 ratio across groups: Normobaric Oxygen Paradox (NOP) group, and a control (CTR) group. The NOP group received 60% oxygen for two hours on days 1, 3, and 5 post-surgery using a venti-mask. The CTR group did not receive oxygen therapy during the post-operatory period starting from day 1. All patients could receive oxygen during the surgery and the first 24 hours post-surgery (day 0) as needed. The belonging to one group or the other was blinded to the laboratory staff.
Pre-surgery, all patients were administered an oral benzodiazepine. General anesthesia was employed, potentially combined with epidural techniques and standard anesthesia monitors were used. The choice of anesthesia technique was at the discretion of the anesthetist. During surgery, patients received 40-50% FiO2 ventilation and were extubated at the surgery's end. Post-surgery, patients were admitted to the ICU for at least 24 hours, receiving oxygen if saturation dropped below 98%. The oxygen protocol commenced 24 hours after ICU admission (day 1). The transfusion threshold was set at 8 g/dl with clinical signs.
Detailed Description:
For anemia treatment in cancer patients human recombinant erythropoietin is often used However its application is constrained due to high costs side effects and limited availability in some regions This research and clinical exploration aim to identify an tool alternative to transfusion
Randomization was conducted post-surgery in a 11 ratio across groups Normobaric Oxygen Paradox NOP group and a control CTR group The NOP group received 60 oxygen for two hours on days 1 3 and 5 post-surgery using a venti-mask The CTR group did not receive oxygen therapy during the post-operatory period starting from day 1 All patients could receive oxygen during the surgery and the first 24 hours post-surgery day 0 as needed The belonging to one group or the other was blinded to the laboratory staff
Pre-surgery all patients were administered an oral benzodiazepine General anesthesia was employed potentially combined with epidural techniques and standard anesthesia monitors were used The choice of anesthesia technique was at the discretion of the anesthetist During surgery patients received 40-50 FiO2 ventilation and were extubated at the surgerys end Post-surgery patients were admitted to the ICU for at least 24 hours receiving oxygen if saturation dropped below 98 The oxygen protocol commenced 24 hours after ICU admission day 1 The transfusion threshold was set at 8 gdl with clinical signs
Randomization was conducted post-surgery in a 11 ratio across groups Normobaric Oxygen Paradox NOP group and a control CTR group The NOP group received 60 oxygen for two hours on days 1 3 and 5 post-surgery using a venti-mask The CTR group did not receive oxygen therapy during the post-operatory period starting from day 1 All patients could receive oxygen during the surgery and the first 24 hours post-surgery day 0 as needed The belonging to one group or the other was blinded to the laboratory staff
Pre-surgery all patients were administered an oral benzodiazepine General anesthesia was employed potentially combined with epidural techniques and standard anesthesia monitors were used The choice of anesthesia technique was at the discretion of the anesthetist During surgery patients received 40-50 FiO2 ventilation and were extubated at the surgerys end Post-surgery patients were admitted to the ICU for at least 24 hours receiving oxygen if saturation dropped below 98 The oxygen protocol commenced 24 hours after ICU admission day 1 The transfusion threshold was set at 8 gdl with clinical signs
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