Evaluation of the Effectiveness of Vibroacoustic Therapy... | NCT03911947

Studies
Evaluation of the Effectiveness of Vibroacoustic Therapy in the Complex Treatment of Acute Respiratory Failure

NCT03911947

Sponsor

Astana Medical University

Status

Completed

Last Update Posted

Jan 14, 2021Actual

Enrollment

113Actual

Phase

Not Applicable

Conditions

Respiratory Failure

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

Jan 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2, 2019Actual

Primary Completion Date

Apr 30, 2020Actual

Completion Date

Jul 31, 2020Actual

First Submitted Date

Apr 8, 2019

First Submission Date that Met QC Criteria

Apr 9, 2019

First Posted Date

Apr 11, 2019Actual

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

Jan 13, 2021

Last Update Posted Date

Jan 14, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

Evaluation of the effectiveness of vibroacoustic therapy in the complex treatment of acute respiratory failure

Detailed Description

Assessing the dynamics of changes in physical, instrumental and laboratory parameters in patients with acute respiratory failure taken in the study according to the inclusion criteria and comparing the results with the control group, studying the effectiveness of vibroacoustic lung therapy.

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

113Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
SaO2 (oxygen status)	Active Comparator	Measurment 4 times per day, ABA (acid-bases analyses)	Device: Vibrolung
PaO2/FiO2 (respiratory index)	Active Comparator	Measurment 4 times per day, ABA (acid-bases analyses)	Device: Vibrolung
AB (actual bicarbonat level)	Active Comparator	Measurment 4 times per day, ABA (acid-bases analyses)	Device: Vibrolung

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Vibrolung	Device	Device for vibroacoustic respiratory therapy	AB (actual bicarbonat level) PaO2/FiO2 (respiratory index) SaO2 (oxygen status)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change of time spent on ventilation	Changing of the time spent by patients on mechanical ventilation	1-2 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

Exclusion Criteria:

children
acute stroke
acute coronary syndrome
DVT
implanted pacemaker
rib fracture
infection on chest

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
City clinical hospital №7		Almaty		050000	Kazakhstan
City clinical hospital №1

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D012131	Respiratory Insufficiency
D011014	Pneumonia

Ancestor Terms

ID	Term
D012120	Respiration Disorders
D012140	Respiratory Tract Diseases
D012141	Respiratory Tract Infections
D007239	Infections

Browse Leaves

Not provided

Browse Branches

Not provided