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

NCT ID: NCT05159401

Last Updated: 2023-08-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

240 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-18

Study Completion Date

2023-05-14

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Respiratory Failure

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

FACTORIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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

Group Type EXPERIMENTAL

prevention of respiratory failure

Intervention Type PROCEDURE

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

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

Group Type EXPERIMENTAL

prevention of respiratory failure

Intervention Type PROCEDURE

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

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

Group Type EXPERIMENTAL

prevention of respiratory failure

Intervention Type PROCEDURE

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

the fourth group:classical manual chest massage with percussion

dynamics blood saturation by pulse oximeter,minute inspiratory lung volume befor/after research

Group Type EXPERIMENTAL

prevention of respiratory failure

Intervention Type PROCEDURE

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

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

prevention of respiratory failure

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

Intervention Type PROCEDURE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Petrovsky National Research Centre of Surgery

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Aleksandr Eremenko

Clinical Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Alexander А Eremenko, prof

Role: STUDY_DIRECTOR

Head of the Intensive Care Unit

Darya Ryabova

Role: PRINCIPAL_INVESTIGATOR

anesthesiologist-resuscitator

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Petrovsky Research National Center of Surgery

Moscow, , Russia

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Russia

References

Explore related publications, articles, or registry entries linked to this study.

Eremenko AA, Zyulyaeva TP, Alferova AP, Fomina DV, Grekova MS, Grin OO, Dmitrieva SS, Molochkov AV, Gens AP, Kotenko KV. [The use of oscillatory respiratory therapy with positive expiratory pressure (PEP-therapy) to restore the functional state of the lungs in patients after cardiac surgery]. Vopr Kurortol Fizioter Lech Fiz Kult. 2023;100(6):21-30. doi: 10.17116/kurort202310006121. Russian.

Reference Type DERIVED
PMID: 38289301 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://pubmed.ncbi.nlm.nih.gov/34965710/

Effectiveness and safety evaluation of a cough stimulation device in early postoperative respiratory rehabilitation in cardiac surgery patients

http://www.vair-journal.com/jour/article/view/603

Comparative Evaluation of Vibratory Physiotherapy Methods in the Early Period after Cardiac Surgery

http://www.reanimatology.com/rmt/article/view/2256/1704

Comparing the Inspiratory Capacity Measurements Obtained by Incentive Spirometry and Ultrasonic Spirography in the Early Postoperative Period in Cardiac Surgery Patients

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9579221/pdf/40635_2022_Article_468.pdf

poster report with publication Intensive Care Medicine Experimental. ESICM 2022. 000290

http://ccforum.biomedcentral.com/counter/pdf/10.1186/s13054-023-04377-x.pdf

poster report with publication Critical Care. 42nd International Symposium on Intensive Care \& Emergency Medicine. P330

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

09052021

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.