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

NCT ID: NCT04435353

Last Updated: 2020-06-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-22

Study Completion Date

2021-02-01

Brief Summary

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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

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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

Conditions

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Respiratory Distress Syndrome Hypoxemia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Prospective\\retrospective study
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors
Research involves single blinding (researcher statistician)

Study Groups

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Time-day of respiratory fail

Objective data

Group Type ACTIVE_COMPARATOR

VibroLUNG

Intervention Type DEVICE

Lungs intensive therapy

Oxygen status

Facultative data

Group Type ACTIVE_COMPARATOR

VibroLUNG

Intervention Type DEVICE

Lungs intensive therapy

Oxugen support

FiO2

Group Type ACTIVE_COMPARATOR

VibroLUNG

Intervention Type DEVICE

Lungs intensive therapy

Adverse outcomes

Complication

Group Type ACTIVE_COMPARATOR

VibroLUNG

Intervention Type DEVICE

Lungs intensive therapy

Interventions

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VibroLUNG

Lungs intensive therapy

Intervention Type DEVICE

Other Intervention Names

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Vibroacustic device

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Astana Medical University

OTHER

Sponsor Role lead

Responsible Party

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Mukatova Irina

PhD. Professor of medicine. Head of deparment pulmonology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mukatova Irina

Astana, Astana, Kazakhstan

Site Status RECRUITING

Center of pulmonology Astana

Astana, , Kazakhstan

Site Status RECRUITING

Countries

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Kazakhstan

Central Contacts

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Irina Mukatova, PhD

Role: CONTACT

8701 535 96 79

Facility Contacts

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Irina Mukatova, MD

Role: primary

8701 535 96 79

Ivan Vahrushev, Dr

Role: primary

8701 196 92 68

Other Identifiers

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AstanaMU

Identifier Type: -

Identifier Source: org_study_id

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