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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04833283
Other study ID # 101499310010796
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 25, 2021
Est. completion date December 1, 2022

Study information

Verified date May 2022
Source I.M. Sechenov First Moscow State Medical University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The aim of the study is to evaluate the effects of intermittent hypoxic-hyperoxic training (IHHT) to protect myocardium against perioperative myocardial injury during cardiac surgery using cardiopulmonary bypass.


Description:

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Study Design


Intervention

Device:
ReOxy Cardio device, intermittent hypoxic-hyperoxic training ( IHHT)
Perform 4 trainings daily of intermittent hypoxic hyperoxic trainings before surgery, using 40 min trainings periods, the patient will receive air with reduced oxygen content (12 %) through a mask under constant monitoring of heart rate (HR) and SpO2. As a safety measure, minimal SpO2 was set at 82 % and maximal accepted increase of heart rate was set to + 50 % of the initial HR. When these values would be reached, the supply of oxygen automatically switched to a hyperoxic gas mixture (35% - 40% O2), inhaling of which would be continued until SpO2 reached 100% (even if SpO2 would be lower before the procedure), which, depending on the rate of saturation reduction, will takes 1 to 3 min (mean 1 min and 50 s).
ReOxy Cardio device
Perform 4 trainings daily of intermittent hypoxic-hyperoxic trainings before surgery, using 40 min trainings periods, whereas moistened air will be delivered through a mask under constant monitoring of heart rate (HR) and SpO2.

Locations

Country Name City State
Russian Federation University Clinical Hospital ?1 Moscow

Sponsors (1)

Lead Sponsor Collaborator
I.M. Sechenov First Moscow State Medical University

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type Measure Description Time frame Safety issue
Primary Death from a cardiac cause Death from cardiac causes during the current hospitalization or 30 days after discharge The first 30 days from the date of discharge
Primary Myocardial infarction Myocardial infarction after current surgery and one month after discharge through study completion, an average of 1 month after discharge
Primary Stroke Stroke in postoperative period until the date of the discharge through study completion, an average of 1 month after discharge
Secondary Electrocardiogram deterioration caused by myocardial ischemia; Electrocardiogram deterioration caused by myocardial ischemia (ST segment elevation or depression, Q wave, negative T wave ) during hospitalization or 30 days after discharge through study completion, an average of 1 month after discharge
Secondary Angina pectoris - typical chest pain III - IV functional class (Canadian Cardiovascular Society classification) Having an angina pectoris during hospitalization or 30 days after discharge through study completion, an average of 1 month after discharge
Secondary Documented episodes of atrial fibrillation/ atrial flutter. Documented episodes of atrial fibrillation or atrial flutter during hospitalization or 30 days after discharge through study completion, an average of 1 month after discharge
Secondary Ventricular proarrhythmia requiring additional therapy Detection of ventricular proarrhythmia during hospitalization or 30 days after discharge through study completion, an average of 1 month after discharge
Secondary Atrioventricular block 2-3 degrees Atrioventricular block 2-3 degree during hospitalization or 30 days after discharge through study completion, an average of 1 month after discharge
Secondary Episodes of hypotension requiring additional therapy Episodes of hypotension (systolic blood pressure of less than 90 mmHg/ diastolic of less than 60 mmHg) requiring additional therapy during hospitalization or 30 days after discharge through study completion, an average of 1 month after discharge
Secondary Length of stay in the intensive care unit through study completion, an average of 1month
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