NCT03911947

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
113

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2019

Geographic Reach
1 country

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 8, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

April 11, 2019

Completed
21 days until next milestone

Study Start

First participant enrolled

May 2, 2019

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2020

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2020

Completed
Last Updated

January 14, 2021

Status Verified

January 1, 2021

Enrollment Period

12 months

First QC Date

April 8, 2019

Last Update Submit

January 13, 2021

Conditions

Respiratory Failure

Keywords

Vibroacoustic therapy, acute respiratory failure, pneumonia

Outcome Measures

Primary Outcomes (1)

  • Change of time spent on ventilation

    Changing of the time spent by patients on mechanical ventilation

    1-2 days

Study Arms (3)

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

VibrolungDEVICE

Device for vibroacoustic respiratory therapy

AB (actual bicarbonat level)PaO2/FiO2 (respiratory index)SaO2 (oxygen status)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • adults
  • P/F less 300 torr
  • ARDS by Berlin convention

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

City clinical hospital №7

Almaty, 050000, Kazakhstan

Location

City clinical hospital №1

Astana, 010000, Kazakhstan

Location

National Cardiac Surgery Center

Astana, 010000, Kazakhstan

Location

Scientific Research Institute of Traumatology and Orthopedics

Astana, 010000, Kazakhstan

Location

Regional cardiology center

Shymkent, 160000, Kazakhstan

Location

MeSH Terms

Conditions

Respiratory InsufficiencyPneumonia

Condition Hierarchy (Ancestors)

Respiration DisordersRespiratory Tract DiseasesRespiratory Tract InfectionsInfectionsLung Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: monitoring of treatment of patients with respiratory failure, the list of therapeutic measures which includes vibroacoustic therapy
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Chair of department

Study Record Dates

First Submitted

April 8, 2019

First Posted

April 11, 2019

Study Start

May 2, 2019

Primary Completion

April 30, 2020

Study Completion

July 31, 2020

Last Updated

January 14, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations

KA(5)