Immunologic Effect of Fraction of Inspired Oxygen
Immunological Effect of Intraoperative Fraction of Inspired Oxygen in Patients Undergoing Major Abdominal Cancer Surgery
1 other identifier
interventional
20
1 country
1
Brief Summary
During anesthesia and surgery, oxygen is routinely administered to all patients. Inspired oxygen concentrations, however, vary between 30% - 100% and oxygen is often administered in a seemingly random manner.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jan 2020
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 13, 2020
CompletedFirst Submitted
Initial submission to the registry
February 23, 2021
CompletedFirst Posted
Study publicly available on registry
February 26, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 1, 2022
CompletedFebruary 26, 2021
February 1, 2021
2 years
February 23, 2021
February 23, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
changes in serum level of interlukin 6
serum level of interlukin 6 will be measured by ELISA technique
before operation (0), 1st, 3rd, and 7th days postoperative
changes in serum level of interlukin 10
serum level of interlukin 6 will be measured by ELISA technique
before operation (0), 1st, 3rd, and 7th days postoperative
Secondary Outcomes (1)
changes in total WBCs count
before operation (0), 1st, 3rd, and 7th days postoperative
Study Arms (2)
hyperoxygenation group
ACTIVE COMPARATORIntraoperative administration of a mixture of 80% oxygen and 20% air
control group
PLACEBO COMPARATORintraoperative administration of 30% oxygen and 70% air
Interventions
after induction of general anaesthesia, different fraction of inspired oxygen will be given to patient according to their group allocation
Eligibility Criteria
You may qualify if:
- candidates for abdominal cancer surgeries
You may not qualify if:
- Patients with chronic diseases, such as chronic obstructive pulmonary disease or pneumonia,
- body mass index (BMI) \>35 kg/m2,
- severe malnutrition (albumin \<3),
- leukopenia (white blood cell \<4,000 g/dL),
- surgery within the previous 30 days and
- O2 saturation \< 90%, as measured using a pulse oximeter
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Assiut University
Asyut, 171516, Egypt
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
February 23, 2021
First Posted
February 26, 2021
Study Start
January 13, 2020
Primary Completion
January 1, 2022
Study Completion
May 1, 2022
Last Updated
February 26, 2021
Record last verified: 2021-02