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Influence of Vibroacoustic Therapy Modes on the Course of Coronavirus Infection

Primary Purpose

COVID-19, Acute Respiratory Failure, Vibration; Exposure

Status
Recruiting
Phase
Not Applicable
Locations
Kazakhstan
Study Type
Interventional
Intervention
Vibrolung
Sponsored by
Astana Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for COVID-19 focused on measuring Acute Respiratory Failure, Vibration; Exposure, COVID-19

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • adults
  • P/F less 300 torr
  • COVID-19 Virus Infection

Exclusion Criteria:

  • children
  • acute stroke
  • acute coronary syndrome
  • DVT
  • implanted pacemaker
  • rib fracture
  • infection on chest

Sites / Locations

  • NATIONAL CENTER Scientific Center of Traumatology and Orthopedics named after Academician Batpenov N.D.Recruiting
  • Multidisciplinary city hospital No. 3 of NursultanRecruiting
  • Multidisciplinary Infectious Diseases Hospital of NursultanRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

SaO2 (oxygen status)

PaO2/FiO2 (respiratory index)

Arm Description

Measurment 4 times per day, ABA (acid-bases analyses)

Measurment 4 times per day, ABA (acid-bases analyses)

Outcomes

Primary Outcome Measures

Change of time spent on ventilation
Changing of the time spent by patients on mechanical ventilation

Secondary Outcome Measures

Full Information

First Posted
November 22, 2021
Last Updated
May 26, 2023
Sponsor
Astana Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05143372
Brief Title
Influence of Vibroacoustic Therapy Modes on the Course of Coronavirus Infection
Official Title
The Effect of Various Modes of Vibroacoustic Therapy on the Course of Coronavirus Infection Complicated by Acute Respiratory Failure.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 9, 2021 (Actual)
Primary Completion Date
September 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Astana Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Assessment of the dynamics of changes in physical, instrumental and laboratory parameters in patients with identified coronavirus infection complicated by acute respiratory failure included in the study in accordance with the inclusion criteria, and comparison of the results with the control group, study of the effect of modes when using vibroacoustic lung therapy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19, Acute Respiratory Failure, Vibration; Exposure
Keywords
Acute Respiratory Failure, Vibration; Exposure, COVID-19

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
SaO2 (oxygen status)
Arm Type
Active Comparator
Arm Description
Measurment 4 times per day, ABA (acid-bases analyses)
Arm Title
PaO2/FiO2 (respiratory index)
Arm Type
Active Comparator
Arm Description
Measurment 4 times per day, ABA (acid-bases analyses)
Intervention Type
Device
Intervention Name(s)
Vibrolung
Intervention Description
Vibroacoustic respiratory therapy
Primary Outcome Measure Information:
Title
Change of time spent on ventilation
Description
Changing of the time spent by patients on mechanical ventilation
Time Frame
1-2 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: adults P/F less 300 torr COVID-19 Virus Infection Exclusion Criteria: children acute stroke acute coronary syndrome DVT implanted pacemaker rib fracture infection on chest
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aidos Konkayev
Phone
+77475339215
Email
konkaev@mail.ru
Facility Information:
Facility Name
NATIONAL CENTER Scientific Center of Traumatology and Orthopedics named after Academician Batpenov N.D.
City
Astana
ZIP/Postal Code
010000
Country
Kazakhstan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Aidos Konkayev
Phone
+77475339215
Email
konkaev@mail.ru
First Name & Middle Initial & Last Name & Degree
Assema Bekhniyazova
Phone
+77752305441
Email
asemabek9@gmail.com
Facility Name
Multidisciplinary city hospital No. 3 of Nursultan
City
Astana
Country
Kazakhstan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Assema Bekniyazova
Facility Name
Multidisciplinary Infectious Diseases Hospital of Nursultan
City
Astana
Country
Kazakhstan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Assema Bekniyazova

12. IPD Sharing Statement

Learn more about this trial

Influence of Vibroacoustic Therapy Modes on the Course of Coronavirus Infection

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