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

Primary Purpose

Respiratory Failure

Status

Completed

Phase

Not Applicable

Locations

Kazakhstan

Study Type

Interventional

Intervention

Vibrolung

About this trial

This is an interventional treatment trial for Respiratory Failure focused on measuring Vibroacoustic therapy, acute respiratory failure, pneumonia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

City clinical hospital №7
City clinical hospital №1
National Cardiac Surgery Center
Scientific Research Institute of Traumatology and Orthopedics
Regional cardiology center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Arm Label

SaO2 (oxygen status)

PaO2/FiO2 (respiratory index)

AB (actual bicarbonat level)

Arm Description

Measurment 4 times per day, ABA (acid-bases analyses)

Outcomes

Primary Outcome Measures

Change of time spent on ventilation

Changing of the time spent by patients on mechanical ventilation

Secondary Outcome Measures

Full Information

NCT ID

NCT03911947

First Posted

April 8, 2019

Last Updated

January 13, 2021

Sponsor

Astana Medical University

1. Study Identification

Unique Protocol Identification Number

NCT03911947

Brief Title

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

Official Title

Assessing the Ventilatory Parameters in Patients With Acute Respiratory Failure After Vibroacoustic Pulmonary Therapy.

Study Type

Interventional

2. Study Status

Record Verification Date

January 2021

Overall Recruitment Status

Completed

Study Start Date

May 2, 2019 (Actual)

Primary Completion Date

April 30, 2020 (Actual)

Study Completion Date

July 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Astana Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Respiratory Failure

Keywords

Vibroacoustic therapy, acute respiratory failure, pneumonia

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Model Description

monitoring of treatment of patients with respiratory failure, the list of therapeutic measures which includes vibroacoustic therapy

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

113 (Actual)

8. Arms, Groups, and Interventions

Arm Title

SaO2 (oxygen status)

Arm Type

Active Comparator

Arm Description

Measurment 4 times per day, ABA (acid-bases analyses)

Arm Title

PaO2/FiO2 (respiratory index)

Arm Type

Active Comparator

Arm Description

Measurment 4 times per day, ABA (acid-bases analyses)

Arm Title

AB (actual bicarbonat level)

Arm Type

Active Comparator

Arm Description

Measurment 4 times per day, ABA (acid-bases analyses)

Intervention Type

Device

Intervention Name(s)

Vibrolung

Intervention Description

Device for vibroacoustic respiratory therapy

Primary Outcome Measure Information:

Title

Change of time spent on ventilation

Description

Changing of the time spent by patients on mechanical ventilation

Time Frame

1-2 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Facility Information:

Facility Name

City clinical hospital №7

City

Almaty

ZIP/Postal Code

050000

Country

Kazakhstan

Facility Name

City clinical hospital №1

City

Astana

ZIP/Postal Code

010000

Country

Kazakhstan

Facility Name

National Cardiac Surgery Center

City

Astana

ZIP/Postal Code

010000

Country

Kazakhstan

Facility Name

Scientific Research Institute of Traumatology and Orthopedics

City

Astana

ZIP/Postal Code

010000

Country

Kazakhstan

Facility Name

Regional cardiology center

City

Shymkent

ZIP/Postal Code

160000

Country

Kazakhstan

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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