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

NCT04833283 | Completed DMC

• 1 other identifier: 101499310010796
• Study Type: interventional
• Target: 115
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Valvular Heart Disease; Aortic Arch Aneurysm; Surgery

Keywords

cardiac pulmonary bypass; reperfusion; interval hypoxic-hyperoxic training; preconditioning; valvular heart disease, aortic arch aneurysm

Outcome Measures

Primary Outcomes (3)

• 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

• Myocardial infarction

  Myocardial infarction after current surgery and one month after discharge

  through study completion, an average of 1 month after discharge

• Stroke

  Stroke in postoperative period until the date of the discharge

  through study completion, an average of 1 month after discharge

Secondary Outcomes (7)

• Electrocardiogram deterioration caused by myocardial ischemia;

  through study completion, an average of 1 month after discharge

• Angina pectoris - typical chest pain III - IV functional class (Canadian Cardiovascular Society classification)

  through study completion, an average of 1 month after discharge

• Documented episodes of atrial fibrillation/ atrial flutter.

  through study completion, an average of 1 month after discharge

• Ventricular proarrhythmia requiring additional therapy

  through study completion, an average of 1 month after discharge

• Atrioventricular block 2-3 degrees

  through study completion, an average of 1 month after discharge

Study Arms (2)

the intervention group intermittent hypoxic-hyperoxic training

EXPERIMENTAL

the intervention group is patients performing intermittent hypoxic-hyperoxic training before operation. ReOxy Cardio device, intermittent hypoxic-hyperoxic training ( IHHT) Intervention Description: 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, intermittent hypoxic-hyperoxic training ( IHHT)

the control group

PLACEBO COMPARATOR

intermittent hypoxic-hyperoxic training control group will be identical to the main group, also underwent four daily procedures before surgery using 40 min training periods with simulation of intermittent hypoxic-hyperoxic trainings by using the same equipment, whereas moistened air will be delivered through a placebo mask

Device: ReOxy Cardio device

Interventions

ReOxy Cardio device, intermittent hypoxic-hyperoxic training ( IHHT) DEVICE

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).

the intervention group intermittent hypoxic-hyperoxic training

ReOxy Cardio device 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.

the control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. Written consent to participate in the study 2. Male or female patients over 18 years 3. Indications for planned replacement of the aortic or mitral valves or operations on the aortic arch.

You may not qualify if:

• \. Individual intolerance to the intermittent hypoxic-hyperoxic training
• \. Acute coronary syndrome after hospitalization and before the surgery
• \. The presence of an acute infectious process after hospitalization and before the surgery (fever, leukocytosis with a shift leukocyte formula to the left, increased erythrocyte sedimentation rate (ESR), increased C-reactive protein)
• \. Uncompensated hypertension at the time of the procedure (systolic blood pres-sure more than 160 mm Hg, diastolic blood pressure more than 110 mm Hg)
• \. Loss of consciousness, severe dizziness
• Occlusive atherosclerotic disease of lower limbs,
• Acute coronary syndrome within 4 weeks before entry
• Preoperative renal insufficiency (serum creatinine higher than 200 mmol/L),
• Acute infectious diseases
• Partial and secondary generalized forms of epilepsy,
• Uncompensated hypertension (Blood pressure at the time of the procedure: systolic blood pressure more than 160 mm Hg, diastolic blood pressure more than 110 mm Hg)
• Severe bronchial asthma with the development of respiratory failure of the II-III degree and individual intolerance to oxygen deficiency.
• \. Severe hepatic impairment (class C child-Pugh) Intervention type
• \. Mental illness (if patients are not capable of understanding the nature, significance and implications of the clinical trial)
• \. Myocardial insufficiency as a component of multiple organ failure in decompensation of liver and kidney diseases

Sponsors & Collaborators

• I.M. Sechenov First Moscow State Medical University: lead

Study Sites (1)

University Clinical Hospital №1

Moscow, 119991, Russia

Location

MeSH Terms

Conditions

Heart Valve Diseases; Aneurysm, Aortic Arch

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Aortic Aneurysm, Thoracic; Aortic Aneurysm; Aneurysm; Vascular Diseases; Aortic Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 23, 2021
• First Posted: April 6, 2021
• Study Start: January 25, 2021
• Primary Completion: May 15, 2022
• Study Completion: December 1, 2022
• Last Updated: December 7, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)