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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04435353
Recruitment Status : Recruiting
First Posted : June 17, 2020
Last Update Posted : June 17, 2020
Sponsor:
Information provided by (Responsible Party):
Mukatova Irina, Astana Medical University

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

Condition or disease Intervention/treatment Phase
Respiratory Distress Syndrome Hypoxemia Device: VibroLUNG Not Applicable

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective\retrospective study
Masking: Single (Outcomes Assessor)
Masking Description: Research involves single blinding (researcher statistician)
Primary Purpose: Treatment
Official Title: Assessment of the Effectiveness of Vibroacoustic Therapy for Respiratory Failure Caused by COVID 19
Actual Study Start Date : March 22, 2020
Estimated Primary Completion Date : December 31, 2020
Estimated Study Completion Date : February 1, 2021


Arm Intervention/treatment
Active Comparator: Time-day of respiratory fail
Objective data
Device: VibroLUNG
Lungs intensive therapy
Other Name: Vibroacustic device

Active Comparator: Oxygen status
Facultative data
Device: VibroLUNG
Lungs intensive therapy
Other Name: Vibroacustic device

Active Comparator: Oxugen support
FiO2
Device: VibroLUNG
Lungs intensive therapy
Other Name: Vibroacustic device

Active Comparator: Adverse outcomes
Complication
Device: VibroLUNG
Lungs intensive therapy
Other Name: Vibroacustic device




Primary Outcome Measures :
  1. Recovery respiratory fail [ Time Frame: 5-7 days ]
    Regression of respiratory failure under the influence of vibroacoustic therapy



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04435353


Contacts
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Contact: Irina Mukatova, PhD 8701 535 96 79 mukatovair@mail.ru

Locations
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Kazakhstan
Mukatova Irina Recruiting
Astana, Nur-Sultan, Kazakhstan, 010000
Contact: Irina Mukatova, MD    8701 535 96 79    mukatovair@mail.ru   
Center of pulmonology Astana Recruiting
Astana, Kazakhstan, 010000
Contact: Ivan Vahrushev, Dr    8701 196 92 68      
Sponsors and Collaborators
Astana Medical University
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Responsible Party: Mukatova Irina, PhD. Professor of medicine. Head of deparment pulmonology, Astana Medical University
ClinicalTrials.gov Identifier: NCT04435353    
Other Study ID Numbers: AstanaMU
First Posted: June 17, 2020    Key Record Dates
Last Update Posted: June 17, 2020
Last Verified: June 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Mukatova Irina, Astana Medical University:
Vibroacustic therapy
COVID19
Pneumonia
Additional relevant MeSH terms:
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Respiratory Distress Syndrome, Newborn
Respiratory Distress Syndrome, Adult
Respiratory Insufficiency
Hypoxia
Lung Diseases
Respiratory Tract Diseases
Respiration Disorders
Infant, Premature, Diseases
Infant, Newborn, Diseases
Signs and Symptoms, Respiratory