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The Use of Vibrational Methods of Influencing the Lungs to Restore Their Functional State

The Use of Vibrational Methods of Influencing the Lungs to Restore Their Functional State After Major Reconstructive Cardiac Surgery

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05159401
Enrollment
240
Registered
2021-12-16
Start date
2022-01-18
Completion date
2023-05-14
Last updated
2023-08-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Respiratory Failure

Keywords

medical rehabilitation; oxygenation

Brief summary

There will be formed of groups for application of vibration methods on the lungs: the method of vibroacoustic lung massage using the BARK VibroLUNG device; the method of oscillating PEP therapy using Acapella DH Green; the method of hardware stimulation of cough with a mechanical insufflator-aspirator Comfort Cough Plus (Comfortable cough Plus). As a control group, classical manual chest massage with percussion and verbal stimulation of cough against the background of chest compressions with a total duration of 15 minutes will be used

Detailed description

The patient signs an informed consent to participate in the study after 10-12 hours tracheal extubation and transfer of the patient to spontaneous respiration. The application of one or another method of influence is carried out by the method of random sampling (the envelope method). Next, a session is conducted using one of the methods of vibrational respiratory therapy. We are exploring the gas composition of arterial blood is examined, spirometry, and the respiratory rate is measured after 20 minutes of the procedure. Further, respiratory therapy sessions are repeated 3 times a day for three days

Interventions

PROCEDUREprevention of respiratory failure

Positive dynamics during CT or X-ray examinations in the form of reduction of hypoventilation zones, straightening of lung tissue

Sponsors

Petrovsky National Research Centre of Surgery
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

Inclusion criteria

1. Age from 18 years to 80 years inclusive. 2. Performed cardiac surgery in IC conditions. 3. The patient's consent to participate in this study.

Exclusion criteria

1. Lack of productive contact with the patient 2. Any disorder in the central nervous system in the perioperative period (acute cerebrovascular accident, coma, posthypoxic encephalopathy), being on a ventilator. 3. Unstable hemodynamics or hemodynamically significant rhythm disturbances 4. Shocks of various etiologies 5. Inability to provide respiratory protection, high risk of aspiration 6. Refusal of the patient to participate in this study

Design outcomes

Primary

MeasureTime frameDescription
the minute inspiratory lung volumehospitalisation period, an average of 1 weekComparison of minute inspiratory lung volume befor/after research using a spirometer
arterial blood oxygenation levelhospitalisation period, an average of 1 dayComparison arterial blood oxygenation level before/after researchin the study of arterial blood
SpO2 more than 92%hospitalisation period, an average of 3 dayComparison of SpO2 by pulse oximeter befor/after research (SpO2\>92%)

Secondary

MeasureTime frameDescription
the number of complicationshospitalisation period, an average of 1 weekComparison of the number of complications befor/after research
assessment of the duration of hospital stayhospitalisation period, an average of 1 weekComparison of assessment of the duration of hospital stay befor/after research

Countries

Russia

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026