Immunologic Effect of Fraction of Inspired Oxygen

Not Applicable

• Conditions: Immune System
• Interventions: Other: fraction of inspired oxygen

• Registration Number: NCT04772794
• Lead Sponsor: Assiut University

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.

Study Timeline

• Study Start: 2020-01-13
• Status Verified: 2021-02
• Study First Submitted: 2021-02-23
• Study First Submitted QC: 2021-02-23
• Last Update Submitted: 2021-02-23
• Study First Posted: 2021-02-26
• Last Update Posted: 2021-02-26
• Primary Completion: 2022-01
• Study Completion: 2022-05

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
control group	fraction of inspired oxygen	intraoperative administration of 30% oxygen and 70% air
hyperoxygenation group	fraction of inspired oxygen	Intraoperative administration of a mixture of 80% oxygen and 20% air

Primary Outcome Measures

Name	Time	Method
changes in serum level of interlukin 6	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	before operation (0), 1st, 3rd, and 7th days postoperative	serum level of interlukin 6 will be measured by ELISA technique

Secondary Outcome Measures

Name	Time	Method
changes in total WBCs count	before operation (0), 1st, 3rd, and 7th days postoperative	measurement of total white blood cells count

Trial Locations

Locations (1)

Assiut University; 🇪🇬 Assiut, Egypt