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

June 16, 2020 updated by: Mukatova Irina, Astana Medical University
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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Kazakhstan
      • Astana, Kazakhstan, 010000
        • Recruiting
        • Center of pulmonology Astana
        • Contact:
          • Ivan Vahrushev, Dr
          • Phone Number: 8701 196 92 68
    • Nur-Sultan
      • Astana, Nur-Sultan, Kazakhstan, 010000
        • Recruiting
        • Mukatova Irina
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Time-day of respiratory fail
Objective data
Device: VibroLUNG
Lungs intensive therapy
Other Names:
  • Vibroacustic device
Active Comparator: Oxygen status
Facultative data
Device: VibroLUNG
Lungs intensive therapy
Other Names:
  • Vibroacustic device
Active Comparator: Oxugen support
FiO2
Device: VibroLUNG
Lungs intensive therapy
Other Names:
  • Vibroacustic device
Active Comparator: Adverse outcomes
Complication
Device: VibroLUNG
Lungs intensive therapy
Other Names:
  • Vibroacustic device

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Recovery respiratory fail
Time Frame: 5-7 days
Regression of respiratory failure under the influence of vibroacoustic therapy
5-7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astana Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 22, 2020

Primary Completion (Anticipated)

December 31, 2020

Study Completion (Anticipated)

February 1, 2021

Study Registration Dates

First Submitted

June 14, 2020

First Submitted That Met QC Criteria

June 16, 2020

First Posted (Actual)

June 17, 2020

Study Record Updates

Last Update Posted (Actual)

June 17, 2020

Last Update Submitted That Met QC Criteria

June 16, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AstanaMU

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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