NCT05143372

Brief Summary

Assessment of the dynamics of changes in physical, instrumental and laboratory parameters in patients with identified coronavirus infection complicated by acute respiratory failure included in the study in accordance with the inclusion criteria, and comparison of the results with the control group, study of the effect of modes when using vibroacoustic lung therapy.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for not_applicable covid19

Timeline
Completed

Started Nov 2021

Longer than P75 for not_applicable covid19

Geographic Reach
1 country

3 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

Study Start

First participant enrolled

November 9, 2021

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

November 22, 2021

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 3, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2023

Completed
Last Updated

February 12, 2024

Status Verified

February 1, 2024

Enrollment Period

1.9 years

First QC Date

November 22, 2021

Last Update Submit

February 9, 2024

Conditions

Keywords

Acute Respiratory FailureVibration; ExposureCOVID-19

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 (2)

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

Interventions

VibrolungDEVICE

Vibroacoustic respiratory therapy

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
  • COVID-19 Virus Infection

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 (3)

NATIONAL CENTER Scientific Center of Traumatology and Orthopedics named after Academician Batpenov N.D.

Astana, 010000, Kazakhstan

Location

Multidisciplinary city hospital No. 3 of Nursultan

Astana, Kazakhstan

Location

Multidisciplinary Infectious Diseases Hospital of Nursultan

Astana, Kazakhstan

Location

Related Publications (1)

  • Konkayev A, Bekniyazova A. Vibroacoustic therapy in the treatment of patients with COVID-19 complicated by respiratory failure: a pilot randomized controlled trial. Front Med (Lausanne). 2023 Dec 14;10:1225384. doi: 10.3389/fmed.2023.1225384. eCollection 2023.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
professor

Study Record Dates

First Submitted

November 22, 2021

First Posted

December 3, 2021

Study Start

November 9, 2021

Primary Completion

September 30, 2023

Study Completion

September 30, 2023

Last Updated

February 12, 2024

Record last verified: 2024-02

Locations