NCT04435353

Brief Summary

Vibroacoustic pulmonary therapy in patients with COVID19 is believed to have a positive effect on oxygen status and a decrease in the duration of respiratory failure

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

2 active sites

Status
unknown

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

March 22, 2020

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 14, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

June 17, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2021

Completed
Last Updated

June 17, 2020

Status Verified

June 1, 2020

Enrollment Period

9 months

First QC Date

June 14, 2020

Last Update Submit

June 16, 2020

Conditions

Respiratory Distress SyndromeHypoxemia

Keywords

Vibroacustic therapyCOVID19Pneumonia

Outcome Measures

Primary Outcomes (1)

  • Recovery respiratory fail

    Regression of respiratory failure under the influence of vibroacoustic therapy

    5-7 days

Study Arms (4)

Time-day of respiratory fail

ACTIVE COMPARATOR

Objective data

Device: VibroLUNG

Oxygen status

ACTIVE COMPARATOR

Facultative data

Device: VibroLUNG

Oxugen support

ACTIVE COMPARATOR

FiO2

Device: VibroLUNG

Adverse outcomes

ACTIVE COMPARATOR

Complication

Device: VibroLUNG

Interventions

VibroLUNGDEVICE

Lungs intensive therapy

Also known as: Vibroacustic device
Adverse outcomesOxugen supportOxygen statusTime-day of respiratory fail

Eligibility Criteria

Age18 Years - 75 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
  • COVID 19 bilateral pneumonia

You may not qualify if:

  • children
  • acute brain stroke
  • acute coronary syndrome
  • pulmonary embolism
  • implanted pacemaker

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Mukatova Irina

Astana, Astana, 010000, Kazakhstan

RECRUITING

Center of pulmonology Astana

Astana, 010000, Kazakhstan

RECRUITING

MeSH Terms

Conditions

Respiratory Distress SyndromeHypoxiaCOVID-19Pneumonia

Condition Hierarchy (Ancestors)

Lung DiseasesRespiratory Tract DiseasesRespiration DisordersSigns and Symptoms, RespiratorySigns and SymptomsPathological Conditions, Signs and SymptomsPneumonia, ViralRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus Infections

Central Study Contacts

Irina Mukatova, PhD

CONTACT

8701 535 96 79mukatovair@mail.ru

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Research involves single blinding (researcher statistician)
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective\\retrospective study
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD. Professor of medicine. Head of deparment pulmonology

Study Record Dates

First Submitted

June 14, 2020

First Posted

June 17, 2020

Study Start

March 22, 2020

Primary Completion

December 31, 2020

Study Completion

February 1, 2021

Last Updated

June 17, 2020

Record last verified: 2020-06

Locations

KA(2)