Back to resultsImmunologic Effect of Fraction of Inspired Oxygen
Primary Purpose
Immune System
Status
Unknown status
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
fraction of inspired oxygen
Sponsored by
About this trial
This is an interventional treatment trial for Immune System focused on measuring fraction of inspired oxygen, hyperoxia, immune system
Eligibility Criteria
Inclusion Criteria:
- candidates for abdominal cancer surgeries
Exclusion Criteria:
- 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
Sites / Locations
- Assiut UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
hyperoxygenation group
control group
Arm Description
Intraoperative administration of a mixture of 80% oxygen and 20% air
intraoperative administration of 30% oxygen and 70% air
Outcomes
Primary Outcome Measures
changes in serum level of interlukin 6
serum level of interlukin 6 will be measured by ELISA technique
changes in serum level of interlukin 10
serum level of interlukin 6 will be measured by ELISA technique
Secondary Outcome Measures
changes in total WBCs count
measurement of total white blood cells count
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04772794
Brief Title
Immunologic Effect of Fraction of Inspired Oxygen
Official Title
Immunological Effect of Intraoperative Fraction of Inspired Oxygen in Patients Undergoing Major Abdominal Cancer Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
February 2021
Overall Recruitment Status
Unknown status
Study Start Date
January 13, 2020 (Actual)
Primary Completion Date
January 2022 (Anticipated)
Study Completion Date
May 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
Detailed Description
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.A striking conundrum is evident immediately when one review studies on the effects of oxygen on cytokines synthesis. Most investigators have found that hyperoxia enhances proinflammtory cytokines transcription and translations (11). In contrast, hyperparic oxygen has generally been shown to suppress stimulus induced porinflammtory cytokine production (12). Other studies have demonstrated that supplemental oxygen improves inflammatory and immune function (13), and it is not associated with clinically important side effect (14). We therefor undertook the current prospective randomized study to investigate whether perioperative supplemental oxygen (30% versus 80%) on pro and anti-inflammatory response in patients undergoing major abdominal cancer surgeries as our primary outcome.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immune System
Keywords
fraction of inspired oxygen, hyperoxia, immune system
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
hyperoxygenation group
Arm Type
Active Comparator
Arm Description
Intraoperative administration of a mixture of 80% oxygen and 20% air
Arm Title
control group
Arm Type
Placebo Comparator
Arm Description
intraoperative administration of 30% oxygen and 70% air
Intervention Type
Other
Intervention Name(s)
fraction of inspired oxygen
Intervention Description
after induction of general anaesthesia, different fraction of inspired oxygen will be given to patient according to their group allocation
Primary Outcome Measure Information:
Title
changes in serum level of interlukin 6
Description
serum level of interlukin 6 will be measured by ELISA technique
Time Frame
before operation (0), 1st, 3rd, and 7th days postoperative
Title
changes in serum level of interlukin 10
Description
serum level of interlukin 6 will be measured by ELISA technique
Time Frame
before operation (0), 1st, 3rd, and 7th days postoperative
Secondary Outcome Measure Information:
Title
changes in total WBCs count
Description
measurement of total white blood cells count
Time Frame
before operation (0), 1st, 3rd, and 7th days postoperative
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
candidates for abdominal cancer surgeries
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Shereen M Kamal, Associate Professor
Phone
01006279209
Email
sheridouh79@yahoo.com
Facility Information:
Facility Name
Assiut University
City
Assiut
ZIP/Postal Code
171516
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shereen M Kamal, Degree
Phone
01006279209
Email
sheridouh79@yahoo.com
First Name & Middle Initial & Last Name & Degree
Rania M Abdelemam, Lecturer
Phone
01006523140
12. IPD Sharing Statement
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Immunologic Effect of Fraction of Inspired Oxygen
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