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Assessment of the Effectiveness of Vibroacoustic Therapy for Respiratory Failure Caused by COVID 19

Primary Purpose

Respiratory Distress Syndrome, Hypoxemia

Status
Unknown status
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 Respiratory Distress Syndrome focused on measuring Vibroacustic therapy, COVID19, Pneumonia

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. adults
  2. P/F less 300 torr
  3. ARDS by Berlin convention
  4. COVID 19 bilateral pneumonia

Exclusion Criteria:

  1. children
  2. acute brain stroke
  3. acute coronary syndrome
  4. pulmonary embolism
  5. implanted pacemaker

Sites / Locations

  • Mukatova IrinaRecruiting
  • Center of pulmonology AstanaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Active Comparator

Active Comparator

Active Comparator

Active Comparator

Arm Label

Time-day of respiratory fail

Oxygen status

Oxugen support

Adverse outcomes

Arm Description

Objective data

Facultative data

FiO2

Complication

Outcomes

Primary Outcome Measures

Recovery respiratory fail
Regression of respiratory failure under the influence of vibroacoustic therapy

Secondary Outcome Measures

Full Information

First Posted
June 14, 2020
Last Updated
June 16, 2020
Sponsor
Astana Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT04435353
Brief Title
Assessment of the Effectiveness of Vibroacoustic Therapy for Respiratory Failure Caused by COVID 19
Official Title
Assessment of the Effectiveness of Vibroacoustic Therapy for Respiratory Failure Caused by COVID 19
Study Type
Interventional

2. Study Status

Record Verification Date
June 2020
Overall Recruitment Status
Unknown status
Study Start Date
March 22, 2020 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
February 1, 2021 (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
Yes

5. Study Description

Brief Summary
Vibroacoustic pulmonary therapy in patients with COVID19 is believed to have a positive effect on oxygen status and a decrease in the duration of respiratory failure
Detailed Description
This study aims to recruit the required number of patients for statistical identification of the effectiveness of vibroacoustic therapy in patients with COVID 19. Obligatory performance criteria will be presented by the duration of the course of respiratory failure and the duration of mechanical ventilation in the main and control groups. Optional performance criteria will be represented by oximetry values and standardization of laboratory parameters

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Distress Syndrome, Hypoxemia
Keywords
Vibroacustic therapy, COVID19, Pneumonia

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective\retrospective study
Masking
Outcomes Assessor
Masking Description
Research involves single blinding (researcher statistician)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Time-day of respiratory fail
Arm Type
Active Comparator
Arm Description
Objective data
Arm Title
Oxygen status
Arm Type
Active Comparator
Arm Description
Facultative data
Arm Title
Oxugen support
Arm Type
Active Comparator
Arm Description
FiO2
Arm Title
Adverse outcomes
Arm Type
Active Comparator
Arm Description
Complication
Intervention Type
Device
Intervention Name(s)
VibroLUNG
Other Intervention Name(s)
Vibroacustic device
Intervention Description
Lungs intensive therapy
Primary Outcome Measure Information:
Title
Recovery respiratory fail
Description
Regression of respiratory failure under the influence of vibroacoustic therapy
Time Frame
5-7 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: adults P/F less 300 torr ARDS by Berlin convention COVID 19 bilateral pneumonia Exclusion Criteria: children acute brain stroke acute coronary syndrome pulmonary embolism implanted pacemaker
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Irina Mukatova, PhD
Phone
8701 535 96 79
Email
mukatovair@mail.ru
Facility Information:
Facility Name
Mukatova Irina
City
Astana
State/Province
Nur-Sultan
ZIP/Postal Code
010000
Country
Kazakhstan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Irina Mukatova, MD
Phone
8701 535 96 79
Email
mukatovair@mail.ru
Facility Name
Center of pulmonology Astana
City
Astana
ZIP/Postal Code
010000
Country
Kazakhstan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ivan Vahrushev, Dr
Phone
8701 196 92 68

12. IPD Sharing Statement

Learn more about this trial

Assessment of the Effectiveness of Vibroacoustic Therapy for Respiratory Failure Caused by COVID 19

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