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

January 13, 2021 updated by: Aidos Konkayev, Astana Medical University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

113

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Kazakhstan
      • Almaty, Kazakhstan, 050000
        • City clinical hospital №7
      • Astana, Kazakhstan, 010000
        • City Clinical Hospital №1
      • Astana, Kazakhstan, 010000
        • National Cardiac Surgery Center
      • Astana, Kazakhstan, 010000
        • Scientific Research Institute of Traumatology and Orthopedics
      • Shymkent, Kazakhstan, 160000
        • Regional cardiology center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: SaO2 (oxygen status)
Measurment 4 times per day, ABA (acid-bases analyses)
Device: Vibrolung
Device for vibroacoustic respiratory therapy
ACTIVE_COMPARATOR: PaO2/FiO2 (respiratory index)
Measurment 4 times per day, ABA (acid-bases analyses)
Device: Vibrolung
Device for vibroacoustic respiratory therapy
ACTIVE_COMPARATOR: AB (actual bicarbonat level)
Measurment 4 times per day, ABA (acid-bases analyses)
Device: Vibrolung
Device for vibroacoustic respiratory therapy

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Astana Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 2, 2019

Primary Completion (ACTUAL)

April 30, 2020

Study Completion (ACTUAL)

July 31, 2020

Study Registration Dates

First Submitted

April 8, 2019

First Submitted That Met QC Criteria

April 9, 2019

First Posted (ACTUAL)

April 11, 2019

Study Record Updates

Last Update Posted (ACTUAL)

January 14, 2021

Last Update Submitted That Met QC Criteria

January 13, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1972

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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