Effects of Oxygen After Abdominal Oncological Surgery

NCT06321874 | Completed

• 1 other identifier: EPHIRAS
• Study Type: interventional
• Target: 49
• Locations: 1 country
• Sites: 1

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

Conditions

Abdominal Cancer

Keywords

oncology; abdominal surgery; oxygen

Outcome Measures

Primary Outcomes (1)

• Percentage change in reticulocyte count

  Percentage change in reticulocyte count from baseline to day six within each group

  6 days

Secondary Outcomes (2)

• haematocrit levels mesure

  6 days

• haemoglobin levels mesure

  6 days

Study Arms (2)

Normobaric Oxygen Paradox (NOP) group

EXPERIMENTAL

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

Procedure: Oxygen

Control (CTR) group

NO INTERVENTION

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

Interventions

Oxygen PROCEDURE

Normobaric Oxygen Paradox (NOP) group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients undergoing abdominal oncological surgery

You may not qualify if:

• 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

Sponsors & Collaborators

• Jules Bordet Institute: lead

Study Sites (1)

Khalife Maher

Brussels, 1000, Belgium

Location

MeSH Terms

Conditions

Neoplasms

Interventions

Oxygen

Intervention Hierarchy (Ancestors)

Chalcogens; Elements; Inorganic Chemicals; Gases

Study Officials

• Maher Khalife, MD

  Jules Bordet Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: The belonging to one group or the other was blinded to the laboratory staff.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 22, 2024
• First Posted: March 20, 2024
• Study Start: January 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: April 10, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)