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

Respiratory Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05159401
• Other study ID #: 09052021
• Status: Completed
• Phase: N/A
• Start date: January 18, 2022
• Est. completion date: May 14, 2023

Study information

• Verified date: August 2023
• Source: Petrovsky National Research Centre of Surgery
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: May 14, 2023
• Est. primary completion date: May 14, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Respiratory Failure
• Respiratory Insufficiency

Intervention

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

Locations

Country	Name	City	State
Russian Federation	Petrovsky Research National Center of Surgery	Moscow

Sponsors (1)

Lead Sponsor	Collaborator
Petrovsky National Research Centre of Surgery

Country where clinical trial is conducted

Russian Federation, 

Outcome

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

External Links

•   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
•   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
•   poster report with publication Critical Care. 42nd International Symposium on Intensive Care & Emergency Medicine. P330
•   poster report with publication Intensive Care Medicine Experimental. ESICM 2022. 000290