Influence of Vibroacoustic Therapy Modes on the Course of Coronavirus Infection

• Sponsor: Astana Medical University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05143372
• Collaborator: (none)
• Enrollment: 80
• Locations: 3
• Arms: 2
• Anticipated Duration (Months): 12.7
• Patients Per Site: 26.7
• Patients Per Site Per Month: 2.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
COVID-19; Acute Respiratory Failure; Vibration; Exposure	Device: Vibrolung	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 80 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: The Effect of Various Modes of Vibroacoustic Therapy on the Course of Coronavirus Infection Complicated by Acute Respiratory Failure.
• Actual Study Start Date: Nov 9, 2021
• Anticipated Primary Completion Date: Dec 1, 2022
• Anticipated Study Completion Date: Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: SaO2 (oxygen status) Measurment 4 times per day, ABA (acid-bases analyses)	Device: Vibrolung; Vibroacoustic respiratory therapy
Active Comparator: PaO2/FiO2 (respiratory index) Measurment 4 times per day, ABA (acid-bases analyses)	Device: Vibrolung; Vibroacoustic respiratory therapy

Outcome Measures

Primary Outcome Measures

1. Change of time spent on ventilation [1-2 days]

   Changing of the time spent by patients on mechanical ventilation

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• adults

• P/F less 300 torr

• COVID-19 Virus Infection

Exclusion Criteria:

• children

• acute stroke

• acute coronary syndrome

• DVT

• implanted pacemaker

• rib fracture

• infection on chest

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	NATIONAL CENTER Scientific Center of Traumatology and Orthopedics named after Academician Batpenov N.D.	Astana		Kazakhstan	010000
2	Multidisciplinary city hospital No. 3 of Nursultan	Astana		Kazakhstan
3	Multidisciplinary Infectious Diseases Hospital of Nursultan	Astana		Kazakhstan

Sponsors and Collaborators

• Astana Medical University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Aidos Konkayev, professor, Astana Medical University
• ClinicalTrials.gov Identifier: NCT05143372
• Other Study ID Numbers: СТЛ-000215
• First Posted: Dec 3, 2021
• Last Update Posted: Jul 20, 2022
• Last Verified: Jul 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Aidos Konkayev, professor, Astana Medical University: Acute Respiratory Failure; Vibration; Exposure; COVID-19
• Additional relevant MeSH terms: COVID-19; Coronavirus Infections; Respiratory Insufficiency; Respiratory Distress Syndrome

Study Results

No Results Posted as of Jul 20, 2022