Effects of Oxygen After Abdominal Oncological Surgery

NCT ID: NCT06321874

Last Updated: 2024-04-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 49 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-01-01
• Study Completion Date: 2011-11-01

Brief Summary

The aims of the research is to determine whether a Hyperoxic intermittent stimuli protocol can increase reticulocyte counts, signififying a rise in EPO production, in patients undergoing abdominal surgery

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 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.

Conditions

Abdominal Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

Normobaric Oxygen Paradox (NOP) group

The NOP group received 60% oxygen for two hours on days 1, 3, and 5 post-surgery using a venti-mask.

Group Type: EXPERIMENTAL

Oxygen

Intervention Type: PROCEDURE

Control (CTR) group

The CTR group did not receive oxygen therapy during the post-operatory period starting from day 1.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Oxygen

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• patients undergoing abdominal oncological surgery

Exclusion Criteria

• GFR<60 ml/minute and/ or creatinine serum level > 2mg/dl
• Transfusion of red blood cells per or postoperatively
• Bleeding requiring repeated transfusions during or after surgery
• Severe respiratory syndrome necessitating continuous oxygen
• Intolerance to oxygen mask

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jules Bordet Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maher Khalife, MD

Role: PRINCIPAL_INVESTIGATOR

Jules Bordet Institute

Locations

Khalife Maher

Brussels, , Belgium

Countries

Belgium

Other Identifiers

EPHIRAS

Identifier Type: -

Identifier Source: org_study_id