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

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

Study Overview

• Status: Completed
• Conditions: Respiratory Failure
• Intervention / Treatment: Procedure: prevention of respiratory failure

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 Type: Interventional
• Enrollment (Actual): 240
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Russian Federation
  • Moscow, Russian Federation
    • Petrovsky Research National Center of Surgery

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
the number of complications	Comparison of the number of complications befor/after research	hospitalisation period, an average of 1 week
assessment of the duration of hospital stay	Comparison of assessment of the duration of hospital stay befor/after research	hospitalisation period, an average of 1 week

Collaborators and Investigators

• Sponsor: 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

Publications and helpful links

Helpful Links

• Effectiveness and safety evaluation of a cough stimulation device in early postoperative respiratory rehabilitation in cardiac surgery patients
• Effectiveness of oscillating PEP-therapy in early period after cardiac surgery
• Comparative Evaluation of Vibratory Physiotherapy Methods in the Early Period after Cardiac Surgery
• Comparing the Inspiratory Capacity Measurements Obtained by Incentive Spirometry and Ultrasonic Spirography in the Early Postoperative Period in Cardiac Surgery Patients
• poster report with publication Intensive Care Medicine Experimental. ESICM 2022. 000290
• poster report with publication Critical Care. 42nd International Symposium on Intensive Care & Emergency Medicine. P330

Study record dates

Study Major Dates

• Study Start (Actual): January 18, 2022
• Primary Completion (Actual): May 14, 2023
• Study Completion (Actual): May 14, 2023

Study Registration Dates

• First Submitted: November 17, 2021
• First Submitted That Met QC Criteria: December 2, 2021
• First Posted (Actual): December 16, 2021

Study Record Updates

• Last Update Posted (Actual): August 23, 2023
• Last Update Submitted That Met QC Criteria: August 18, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: medical rehabilitation; oxygenation
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Respiration Disorders; Respiratory Insufficiency
• Other Study ID Numbers: 09052021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No