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

Sponsor

Petrovsky National Research Centre of Surgery (Other)

Overall Status

Recruiting

CT.gov ID

NCT05159401

Collaborator

(none)

240

Enrollment

Location

Arms

21.4

Anticipated Duration (Months)

11.2

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Respiratory Failure	Procedure: prevention of respiratory failure	N/A

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

Anticipated Enrollment :

240 participants

Allocation:

Randomized

Intervention Model:

Factorial Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Jan 18, 2022

Anticipated Primary Completion Date :

Nov 1, 2023

Anticipated Study Completion Date :

Nov 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Experimental: the first group: the method of vibroacoustic lung massage using the "BARK VibroLUNG" device dynamics blood saturation by pulse oximeter,minute inspiratory lung volume befor/after research	Procedure: prevention of respiratory failure Positive dynamics during CT or X-ray examinations in the form of reduction of hypoventilation zones, straightening of lung tissue
Experimental: the second group:the method of oscillating REР therapy using Acapella DH Green dynamics blood saturation by pulse oximeter,minute inspiratory lung volume befor/after research	Procedure: prevention of respiratory failure Positive dynamics during CT or X-ray examinations in the form of reduction of hypoventilation zones, straightening of lung tissue
Experimental: the third group:the method of hardware stimulation of cough (Comfortable cough Plus) dynamics blood saturation by pulse oximeter,minute inspiratory lung volume befor/after research	Procedure: prevention of respiratory failure Positive dynamics during CT or X-ray examinations in the form of reduction of hypoventilation zones, straightening of lung tissue
Experimental: the fourth group:classical manual chest massage with percussion dynamics blood saturation by pulse oximeter,minute inspiratory lung volume befor/after research	Procedure: prevention of respiratory failure Positive dynamics during CT or X-ray examinations in the form of reduction of hypoventilation zones, straightening of lung tissue

Outcome Measures

Primary Outcome Measures

the minute inspiratory lung volume [hospitalisation period, an average of 1 week]
Comparison of minute inspiratory lung volume befor/after research using a spirometer
arterial blood oxygenation level [hospitalisation period, an average of 1 day]
Comparison arterial blood oxygenation level before/after researchin the study of arterial blood
SpO2 more than 92% [hospitalisation period, an average of 3 day]
Comparison of SpO2 by pulse oximeter befor/after research (SpO2>92%)

Secondary Outcome Measures

the number of complications [hospitalisation period, an average of 1 week]
Comparison of the number of complications befor/after research
assessment of the duration of hospital stay [hospitalisation period, an average of 1 week]
Comparison of assessment of the duration of hospital stay befor/after research

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Petrovsky Research National Center of Surgery	Moscow		Russian Federation

Sponsors and Collaborators

Petrovsky National Research Centre of Surgery

Investigators

Study Director: Alexander А Eremenko, prof, Head of the Intensive Care Unit
Principal Investigator: Darya Ryabova, anesthesiologist-resuscitator

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Aleksandr Eremenko, Clinical Professor, Petrovsky National Research Centre of Surgery

ClinicalTrials.gov Identifier:

NCT05159401

Other Study ID Numbers:

09052021

First Posted:

Dec 16, 2021

Last Update Posted:

Feb 9, 2022

Last Verified:

Feb 1, 2022

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

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

Additional relevant MeSH terms:

Respiratory Insufficiency

Study Results

No Results Posted as of Feb 9, 2022