Assessment of the Effectiveness of Vibroacoustic Therapy for Respiratory Failure Caused by COVID 19

Sponsor

Astana Medical University (Other)

Overall Status

Unknown status

CT.gov ID

NCT04435353

Collaborator

(none)

200

Enrollment

Locations

Arms

10.4

Anticipated Duration (Months)

100

Patients Per Site

9.6

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Respiratory Distress Syndrome Hypoxemia	Device: VibroLUNG	N/A

Detailed Description

This study aims to recruit the required number of patients for statistical identification of the effectiveness of vibroacoustic therapy in patients with COVID 19. Obligatory performance criteria will be presented by the duration of the course of respiratory failure and the duration of mechanical ventilation in the main and control groups. Optional performance criteria will be represented by oximetry values and standardization of laboratory parameters

Study Design

Study Type:

Interventional

Anticipated Enrollment :

200 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Prospective\retrospective studyProspective\retrospective study

Masking:

Single (Outcomes Assessor)

Masking Description:

Research involves single blinding (researcher statistician)

Primary Purpose:

Treatment

Official Title:

Assessment of the Effectiveness of Vibroacoustic Therapy for Respiratory Failure Caused by COVID 19

Actual Study Start Date :

Mar 22, 2020

Anticipated Primary Completion Date :

Dec 31, 2020

Anticipated Study Completion Date :

Feb 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Time-day of respiratory fail Objective data	Device: VibroLUNG Lungs intensive therapy Other Names: Vibroacustic device
Active Comparator: Oxygen status Facultative data	Device: VibroLUNG Lungs intensive therapy Other Names: Vibroacustic device
Active Comparator: Oxugen support FiO2	Device: VibroLUNG Lungs intensive therapy Other Names: Vibroacustic device
Active Comparator: Adverse outcomes Complication	Device: VibroLUNG Lungs intensive therapy Other Names: Vibroacustic device

Outcome Measures

Primary Outcome Measures

Recovery respiratory fail [5-7 days]
Regression of respiratory failure under the influence of vibroacoustic therapy

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

adults
P/F less 300 torr
ARDS by Berlin convention
COVID 19 bilateral pneumonia

Exclusion Criteria:

children
acute brain stroke
acute coronary syndrome
pulmonary embolism
implanted pacemaker

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mukatova Irina	Astana	Nur-Sultan	Kazakhstan	010000
2	Center of pulmonology Astana	Astana		Kazakhstan	010000

Sponsors and Collaborators

Astana Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Mukatova Irina, PhD. Professor of medicine. Head of deparment pulmonology, Astana Medical University

ClinicalTrials.gov Identifier:

NCT04435353

Other Study ID Numbers:

AstanaMU

First Posted:

Jun 17, 2020

Last Update Posted:

Jun 17, 2020

Last Verified:

Jun 1, 2020

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Keywords provided by Mukatova Irina, PhD. Professor of medicine. Head of deparment pulmonology, Astana Medical University

Vibroacustic therapy

COVID19

Pneumonia

Additional relevant MeSH terms:

COVID-19

Respiratory Distress Syndrome

Respiratory Distress Syndrome, Newborn

Respiratory Insufficiency

Hypoxia

Study Results

No Results Posted as of Jun 17, 2020