Assessment of the Effectiveness of Vibroacoustic Therapy... | NCT04435353

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

NCT04435353

Sponsor

Astana Medical University

Status

Unknown status

Last Update Posted

Jun 17, 2020Actual

Enrollment

200Estimated

Phase

Not Applicable

Conditions

Respiratory Distress Syndrome
Hypoxemia

Interventions

VibroLUNG

Countries

Kazakhstan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 22, 2020Actual

Primary Completion Date

Dec 31, 2020Estimated

Completion Date

Feb 1, 2021Estimated

First Submitted Date

Jun 14, 2020

First Submission Date that Met QC Criteria

Jun 16, 2020

First Posted Date

Jun 17, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 16, 2020

Last Update Posted Date

Jun 17, 2020Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mukatova Irina, PhD. Professor of medicine. Head of deparment pulmonology, Astana Medical UniversityPrincipal Investigator

Lead Sponsor

Astana Medical UniversityOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Time-day of respiratory fail	Active Comparator	Objective data	Device: VibroLUNG
Oxygen status	Active Comparator	Facultative data	Device: VibroLUNG
Oxugen support	Active Comparator	FiO2	Device: VibroLUNG
Adverse outcomes	Active Comparator	Complication	Device: VibroLUNG

Interventions

Name	Type	Description	Arm Group Labels	Other Names
VibroLUNG	Device	Lungs intensive therapy	Adverse outcomes Oxugen support Oxygen status Time-day of respiratory fail

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Irina Mukatova, PhD	Contact	8701 535 96 79		mukatovair@mail.ru

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Mukatova Irina	Recruiting	Astana	Astana	010000	Kazakhstan

Condition Browse Module

MeSH Terms

ID	Term
D012128	Respiratory Distress Syndrome
D000860	Hypoxia
D000086382	COVID-19
D011014	Pneumonia

Ancestor Terms

ID	Term
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D012120	Respiration Disorders
D012818	Signs and Symptoms, Respiratory

Browse Leaves

Not provided

Browse Branches

Not provided