The Use of Vibrational Methods of Influencing the Lungs to Restore Their Functional State After Major Reconstructive Cardiac Surgery
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 240
- Locations
- 1
- Primary Endpoint
- the minute inspiratory lung volume
Study Overview
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
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Factorial
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Age from 18 years to 80 years inclusive.
- •Performed cardiac surgery in IC conditions.
- •The patient's consent to participate in this study.
Exclusion Criteria
- •Lack of productive contact with the patient
- •Any disorder in the central nervous system in the perioperative period (acute cerebrovascular accident, coma, posthypoxic encephalopathy), being on a ventilator.
- •Unstable hemodynamics or hemodynamically significant rhythm disturbances
- •Shocks of various etiologies
- •Inability to provide respiratory protection, high risk of aspiration
- •Refusal of the patient to participate in this study
Outcomes
Primary Outcomes
the minute inspiratory lung volume
Time Frame: hospitalisation period, an average of 1 week
Comparison of minute inspiratory lung volume befor/after research using a spirometer
arterial blood oxygenation level
Time Frame: hospitalisation period, an average of 1 day
Comparison arterial blood oxygenation level before/after researchin the study of arterial blood
SpO2 more than 92%
Time Frame: hospitalisation period, an average of 3 day
Comparison of SpO2 by pulse oximeter befor/after research (SpO2\>92%)
Secondary Outcomes
- the number of complications(hospitalisation period, an average of 1 week)
- assessment of the duration of hospital stay(hospitalisation period, an average of 1 week)
Investigators
Aleksandr Eremenko
Clinical Professor
Petrovsky National Research Centre of Surgery