Selected Lysosomal Enzyme Activities and the Oxidant-antioxidant Balance in Hyperbaric Oxygen Condition.

N/ACompletedNCT06401941

Nicolaus Copernicus University78 enrolled

Overview

The aim of the research project was to investigate the effects of hyperbaric oxygen (HBO) treatment on the redox equilibrium in individuals with different pathological conditions. Both hyperbaric oxygenation and the pathological condition are associated with redox imbalance (oxidative stress), however, HBO is successfully used in the treatment of chronic wounds, e.g., diabetic foot syndrome, as well as in sudden and acute hearing loss, e.g., acute acoustic trauma or idiopathic sudden sensorineural hearing loss.

The study involed in sudden sensorineural hearing loss (SSNHL) patients, individuals with difficult-to-heal skin wounds following mechanical injuries, and diabetic foot patients. HBO therapy, which involved inhalation of 100% oxygen at a pressure of 2.5 atm, consisted of 14-30 sessions depending on the clinical case. The study material was venous blood drawn three times: before and after the first session, and after the last HBO procedure. The following variables were evaluated: the concentrations of thiobarbituric acid reactive substances (TBARS), malondialdehyde (MDA) and conjugated dienes (CD) in plasma and erythrocytes, the activities of catalase (CAT), superoxide dismutase (SOD) and glutathione peroxidase (GPx) in erythrocytes, as well as, blood counts.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

Conditions

Hyperbaric Oxygenation

Interventions

Hyperbaric Oxygen TherapyPROCEDURE

HBO session includes three 20-minute inhalations of pure oxygen in a hyperbaric chamber utilizing specially fitted face masks for each patient. The session is conducted as follows: 10 minutes compression of up to 2.5 atm (0.25 MPa), inhalation of 100% oxygen for 20 minutes, a 5-minute break in the chamber without the mask (oxygen concentration up to 23%, constant temperature (room) and humidity), again 20 minutes inhalation of 100% oxygen, another 5-minute break (the same condition), the last 20 minutes inhalation of 100% oxygen, and finally a 10-minute decompression. The total duration of the session was 90 minutes.

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * signed informed consent form for participation in the study Exclusion Criteria: * other pathological conditions (disorders, wounds, diseases) * bad feeling of the participant on the day of the study, * refraining from smoking, drinking alcohol, and the consumption of any dietary supplements that can affect the oxidant-antioxidant balance.

Outcomes

Primary Outcomes

Thiobarbituric acid reactive substances (TBARS)

Lipid peroxidation index represented by malondialdehyde (MDA), determined in plasma and erythrocytes.

Time frame: Three days, three different condition measurements

Malondialdehyde (MDA)

Lipid peroxidation index; pure MDA determined using high-performance liquid chromatography in plasma and erythrocytes.

Time frame: Three days, three different condition measurements

Conjugated dienes (CD)

Lipid peroxidation index, determined in plasma and erythrocytes.

Time frame: Three days, three different condition measurements

Catalase (CAT)

Antioxidant enzyme, determined in erythrocytes.

Time frame: Three days, three different condition measurements

Superoxide dismutase (SOD)

Antioxidant enzyme, determined in erythrocytes.

Time frame: Three days, three different condition measurements

Glutathione peroxidase (GPx)

Antioxidant enzyme, determined in erythrocytes.

Time frame: Three days, three different condition measurements

Secondary Outcomes

White blood cell count (WBC)

Leukocytes found in peripheral blood with specyfication of their types: lymphocytes, monocytes, neutrophils, eosinophils, basophils.