Ignite Creation Date:
2024-05-06 @ 7:09 PM
Last Modification Date:
2024-10-26 @ 3:01 PM
Study NCT ID:
NCT05911100
Status:
RECRUITING
Last Update Posted:
2023-06-22
First Post:
2023-06-18
Brief Title:
State of Oxygen Metabolism Cardiovascular and Respiratory System Reserve Capacity in Patients Who Underwent COVID-19
Sponsor:
Meshalkin Research Institute of Pathology of Circulation
Organization:
Meshalkin Research Institute of Pathology of Circulation
Study Overview
Official Title:
Evaluation of the Effectiveness of Medical Rehabilitation of COVID-19 Patients Based on the Study of Individual Physiological Parameters of Oxygen Metabolism and the Reserve Capabilities of the Cardiovascular and Respiratory Systems
Status:
RECRUITING
Status Verified Date:
2023-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This clinical study will create an evidence base for rehabilitation approach which will be used for restoration of pulmonary ventilation and gas exchange increase of tolerance to physical load reduced in patients who underwent COVID-19
The aim of the present clinical study is to evaluate the effectiveness of medical rehabilitation of COVID-19 patients based on the study of individual physiological parameters of oxygen metabolism and reserve capabilities of the cardiovascular and respiratory systems
The aim of the present clinical study is to evaluate the effectiveness of medical rehabilitation of COVID-19 patients based on the study of individual physiological parameters of oxygen metabolism and reserve capabilities of the cardiovascular and respiratory systems
Detailed Description:
After an interview about the possibility of taking part in the study the patient is presented with an informed consent form explaining all the questions of interest In the case of consent to participate in the study the patient and the researcher fill out all the necessary fields of the two copies of the informed consent and sign it If necessary the researcher re-explains any information about the study One copy of the informed consent remains with the patient and the second copy is kept by the investigator as required by Good Clinical Practice
Once informed consent is obtained an Individual Registration Card IRC is completed for the patient enrolled in the study Completion of the IRC also continues until completion of the second phase of rehabilitation
Pulmonary functional tests cardiopulmonary stress testing CPT are performed on day 1 or 2 of inclusion of the patient in the rehabilitation program of Federal Research Center for Fundamental and Translational Medicine FRC FTM using MasterScreen Pneumo Jaeger Germany and Oxycon Pro ergospirometry systems Jaeger Germany in accordance with international standards The indexes of external respiration are brought to BTPS conditions and gas exchange - STPD The protocol of stress testing is chosen individually based on the proper values in accordance with the age sex and anthropometric data of the patient The study is conducted up to the individual maximum followed by a recovery period The anaerobic threshold is determined using the V-slope method After peak load is reached it is gradually reduced Observation is continued until complete recovery of hemodynamic parameters gas exchange in case of adverse symptoms - until their disappearance Repeated testing is performed after the rehabilitation program before discharge from the FTC MTF
Thoracic MSCT is performed on day 1-2 of inclusion of a patient into the rehabilitation program of the FRC FTM to assess the lesion of the bronchopulmonary system after COVID-19
Questionnaires describing the severity of the underlying disease mMRC respiratory impairment scale BODE pulmonology risk scale SMRT-CO respiratory support need scale and SF-36 quality of life questionnaire are completed at study inclusion and after the rehabilitation program before discharge from the FRC FTM
Once informed consent is obtained an Individual Registration Card IRC is completed for the patient enrolled in the study Completion of the IRC also continues until completion of the second phase of rehabilitation
Pulmonary functional tests cardiopulmonary stress testing CPT are performed on day 1 or 2 of inclusion of the patient in the rehabilitation program of Federal Research Center for Fundamental and Translational Medicine FRC FTM using MasterScreen Pneumo Jaeger Germany and Oxycon Pro ergospirometry systems Jaeger Germany in accordance with international standards The indexes of external respiration are brought to BTPS conditions and gas exchange - STPD The protocol of stress testing is chosen individually based on the proper values in accordance with the age sex and anthropometric data of the patient The study is conducted up to the individual maximum followed by a recovery period The anaerobic threshold is determined using the V-slope method After peak load is reached it is gradually reduced Observation is continued until complete recovery of hemodynamic parameters gas exchange in case of adverse symptoms - until their disappearance Repeated testing is performed after the rehabilitation program before discharge from the FTC MTF
Thoracic MSCT is performed on day 1-2 of inclusion of a patient into the rehabilitation program of the FRC FTM to assess the lesion of the bronchopulmonary system after COVID-19
Questionnaires describing the severity of the underlying disease mMRC respiratory impairment scale BODE pulmonology risk scale SMRT-CO respiratory support need scale and SF-36 quality of life questionnaire are completed at study inclusion and after the rehabilitation program before discharge from the FRC FTM
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None