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

The Impact of Staying in Hyperbaric Oxygen Conditions on the Oxidant-antioxidant Balance and the Activities of Selected Lysosomal Enzymes

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06401941
Enrollment
78
Registered
2024-05-07
Start date
2016-04-26
Completion date
2020-12-31
Last updated
2024-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antioxidants, Hyperbaric Oxygenation, Oxidative Stress, Oxygen Toxicity

Brief summary

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.

Detailed description

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.

Interventions

PROCEDUREHyperbaric Oxygen Therapy

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.

Sponsors

Nicolaus Copernicus University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Thiobarbituric acid reactive substances (TBARS)Three days, three different condition measurementsLipid peroxidation index represented by malondialdehyde (MDA), determined in plasma and erythrocytes.
Malondialdehyde (MDA)Three days, three different condition measurementsLipid peroxidation index; pure MDA determined using high-performance liquid chromatography in plasma and erythrocytes.
Conjugated dienes (CD)Three days, three different condition measurementsLipid peroxidation index, determined in plasma and erythrocytes.
Catalase (CAT)Three days, three different condition measurementsAntioxidant enzyme, determined in erythrocytes.
Superoxide dismutase (SOD)Three days, three different condition measurementsAntioxidant enzyme, determined in erythrocytes.
Glutathione peroxidase (GPx)Three days, three different condition measurementsAntioxidant enzyme, determined in erythrocytes.

Secondary

MeasureTime frameDescription
Mean corpuscular hemoglobin concentration (MCHC)Two days, two different condition measurementsMCH expressed in a unit of blood volume.
Red cell distribution width (RDW)Two days, two different condition measurementsDifferences in the volume and size of erythrocytes.
Platelets (PLT)Two days, two different condition measurementsThrombocytes found in peripheral blood.
White blood cell count (WBC)Two days, two different condition measurementsLeukocytes found in peripheral blood with specyfication of their types: lymphocytes, monocytes, neutrophils, eosinophils, basophils.
Mean platelet volume (MPV)Two days, two different condition measurementsMean volume of thrombocytes in the blood.
Platelet distribution width (PDW)Two days, two different condition measurementsMeasurement of platelet anisocytosis calculated from the distribution of individual platelet volumes.
Plateletcrit (PCT)Two days, two different condition measurementsVolume occupied by platelets in the blood.
Red blood cell count (RBS)Two days, two different condition measurementsErythrocytes found in peripheral blood.
Hemoglobin (HGB)Two days, two different condition measurementsMean concentration of hemoglobin in the blood.
Hematocrit (HCT)Two days, two different condition measurementsThe percentage of red blood cells in the blood.
Mean corpuscular volume (MCV)Two days, two different condition measurementsMean volume of erythrocytes in the blood.
Mean corpuscular hemoglobin (MCH)Two days, two different condition measurementsMean mass of hemoglobin in an erythrocyte.

Countries

Poland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026