MedDataX Logo

Immunologic Effect of Fraction of Inspired Oxygen

NCT ID: NCT04772794

Last Updated: 2021-02-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-13

Study Completion Date

2022-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

See the medical conditions and disease areas that this research is targeting or investigating.

Immune System

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

fraction of inspired oxygen hyperoxia immune system

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

hyperoxygenation group

Intraoperative administration of a mixture of 80% oxygen and 20% air

Group Type ACTIVE_COMPARATOR

fraction of inspired oxygen

Intervention Type OTHER

after induction of general anaesthesia, different fraction of inspired oxygen will be given to patient according to their group allocation

control group

intraoperative administration of 30% oxygen and 70% air

Group Type PLACEBO_COMPARATOR

fraction of inspired oxygen

Intervention Type OTHER

after induction of general anaesthesia, different fraction of inspired oxygen will be given to patient according to their group allocation

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

fraction of inspired oxygen

after induction of general anaesthesia, different fraction of inspired oxygen will be given to patient according to their group allocation

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Assiut University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Shereen Mamdouh

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Assiut University

Asyut, , Egypt

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Egypt

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Shereen M Kamal, Associate Professor

Role: CONTACT

Phone: 01006279209

Email: [email protected]

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Shereen M Kamal, Degree

Role: primary

Rania M Abdelemam, Lecturer

Role: backup

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

519

Identifier Type: -

Identifier Source: org_study_id