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Effects of Oxygen After Abdominal Oncological Surgery

Exploring Postoperative Effects of Hyperoxic Intermittent Stimuli on Reticulocytes Levels in Abdominal Surgery: A Randomized Single-blind Study

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06321874
Acronym
EPHIRAS
Enrollment
49
Registered
2024-03-20
Start date
2011-01-01
Completion date
2011-11-01
Last updated
2024-04-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abdominal Cancer

Keywords

oncology, abdominal surgery, oxygen

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.

Interventions

PROCEDUREOxygen

Sponsors

Jules Bordet Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Caregiver)

Masking description

The belonging to one group or the other was blinded to the laboratory staff.

Intervention model description

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.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Percentage change in reticulocyte count6 daysPercentage change in reticulocyte count from baseline to day six within each group

Secondary

MeasureTime frameDescription
haematocrit levels mesure6 dayshaematocrit levels mesured at baseline and on day six
haemoglobin levels mesure6 dayshaemoglobin levels mesured at baseline and on day six

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026