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

Astana Medical University

Status: Unknown

Conditions: Respiratory Distress Syndrome; Hypoxemia

Treatments: Device: VibroLUNG

Study type: Interventional

Funder types: Other

Identifiers

NCT04435353

AstanaMU

Details and patient eligibility

About

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

Full 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

Enrollment: 200 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. adults
2. P/F less 300 torr
3. ARDS by Berlin convention
4. COVID 19 bilateral pneumonia

Exclusion criteria

1. children
2. acute brain stroke
3. acute coronary syndrome
4. pulmonary embolism
5. implanted pacemaker

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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200 participants in 4 patient groups

Time-day of respiratory fail

Active Comparator group

Description:

Objective data

Treatment:

Device: VibroLUNG

Oxygen status

Active Comparator group

Description:

Facultative data

Treatment:

Device: VibroLUNG

Oxugen support

Active Comparator group

Description:

FiO2

Treatment:

Device: VibroLUNG

Adverse outcomes

Active Comparator group

Description:

Complication

Treatment:

Device: VibroLUNG