The Effects of Intermittent Hypoxic-hyperoxic Preconditioning for Patients Undergoing Cardiopulmonary Bypass.

NACompletedINTERVENTIONAL
Enrollment

115

Participants

Timeline

Start Date

January 25, 2021

Primary Completion Date

May 15, 2022

Study Completion Date

December 1, 2022

Conditions
Valvular Heart DiseaseAortic Arch AneurysmSurgery
Interventions
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).

DEVICE

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.

Trial Locations (1)

119991

University Clinical Hospital №1, Moscow

All Listed Sponsors
lead

I.M. Sechenov First Moscow State Medical University

OTHER

NCT04833283 - The Effects of Intermittent Hypoxic-hyperoxic Preconditioning for Patients Undergoing Cardiopulmonary Bypass. | Biotech Hunter | Biotech Hunter