Immune SystemNCT04772794
Immunologic Effect of Fraction of Inspired Oxygen
A study testing fraction of inspired oxygen in people with Immune System, run by Assiut University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Immune System
- What is being tested?
- fraction of inspired oxygen
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteEgypt
- Study dates
- 13 Jan 2020to May 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- candidates for abdominal cancer surgeries
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Assiut University
Asyut, 171516
Shereen M Kamal, Degree, 01006279209, sheridouh79@yahoo.com
Rania M Abdelemam, Lecturer, 01006523140
About this study
Official title: Immunological Effect of Intraoperative Fraction of Inspired Oxygen in Patients Undergoing Major Abdominal Cancer Surgery
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.
Read the 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.
- Conditions
- Immune System
- Being tested
- fraction of inspired oxygen
- Keywords
- fraction of inspired oxygen, hyperoxia, immune system
- Medical subject headings
- Hyperoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
fraction of inspired oxygenOther
after induction of general anaesthesia, different fraction of inspired oxygen will be given to patient according to their group allocation
| Study group | Role | What they receive |
|---|---|---|
| hyperoxygenation group | Active comparator | Intraoperative administration of a mixture of 80% oxygen and 20% air Receives: Other: fraction of inspired oxygen |
| control group | Placebo comparator | intraoperative administration of 30% oxygen and 70% air Receives: Other: fraction of inspired oxygen |
What is being measured
The primary outcome is the main question the study is designed to answer.
changes in serum level of interlukin 6
serum level of interlukin 6 will be measured by ELISA technique
Measured: 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
Measured: before operation (0), 1st, 3rd, and 7th days postoperative
Secondary outcomes (1)
changes in total WBCs count
measurement of total white blood cells count
Measured: before operation (0), 1st, 3rd, and 7th days postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2021
- Study start13 Jan 2020
- Primary completionJan 2022 (estimated)
- Study completionMay 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Immune SystemStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Shereen Mamdouh, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04772794
- Sponsor's protocol ID
- 519
- Status last verified
- Feb 2021
- First submitted
- 23 Feb 2021
- Last updated
- 26 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunological Effect of Intraoperative Fraction of Inspired Oxygen in Patients Undergoing Major Abdominal Cancer Surgery
- ClinicalTrials.gov ID
- NCT04772794
- Acronym / sponsor ID
- 519
- Conditions
- Immune System
- Keywords
- fraction of inspired oxygen, hyperoxia, immune system
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 13 Jan 2020 (actual)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- May 2022 (estimated)
- First posted
- 26 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| hyperoxygenation group | Active comparator | Other: fraction of inspired oxygenIntraoperative administration of a mixture of 80% oxygen and 20% air |
| control group | Placebo comparator | Other: fraction of inspired oxygenintraoperative administration of 30% oxygen and 70% air |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- candidates for abdominal cancer surgeries
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| fraction of inspired oxygenafter induction of general anaesthesia, different fraction of inspired oxygen will be given to patient according to their group allocation | Other | control group, hyperoxygenation group |
Primary outcome
changes in serum level of interlukin 6
Time frame: before operation (0), 1st, 3rd, and 7th days postoperative
serum level of interlukin 6 will be measured by ELISA technique
changes in serum level of interlukin 10
Time frame: before operation (0), 1st, 3rd, and 7th days postoperative
serum level of interlukin 6 will be measured by ELISA technique
1 secondary outcome
changes in total WBCs count
Time frame: before operation (0), 1st, 3rd, and 7th days postoperative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2021.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing fraction of inspired oxygen in people with Immune System, run by Assiut University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shereen M Kamal, Associate Professor (01006279209, sheridouh79@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
changes in serum level of interlukin 6 (time frame: before operation (0), 1st, 3rd, and 7th days postoperative). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2021.