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

NCT05159401 | Completed

• 1 other identifier: 09052021
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

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

Conditions

Respiratory Failure

Keywords

medical rehabilitation; oxygenation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (2)

• 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

Study Arms (4)

the first group: the method of vibroacoustic lung massage using the "BARK VibroLUNG" device

EXPERIMENTAL

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

Procedure: prevention of respiratory failure

the second group:the method of oscillating REР therapy using Acapella DH Green

EXPERIMENTAL

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

Procedure: prevention of respiratory failure

the third group:the method of hardware stimulation of cough (Comfortable cough Plus)

EXPERIMENTAL

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

Procedure: prevention of respiratory failure

the fourth group:classical manual chest massage with percussion

EXPERIMENTAL

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

Procedure: prevention of respiratory failure

Interventions

prevention of respiratory failure PROCEDURE

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

the first group: the method of vibroacoustic lung massage using the "BARK VibroLUNG" device; the fourth group:classical manual chest massage with percussion; the second group:the method of oscillating REР therapy using Acapella DH Green; the third group:the method of hardware stimulation of cough (Comfortable cough Plus)

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age from 18 years to 80 years inclusive.
• Performed cardiac surgery in IC conditions.
• The patient's consent to participate in this study.

You may not qualify if:

• 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

Sponsors & Collaborators

• Petrovsky National Research Centre of Surgery: lead

Study Sites (1)

Petrovsky Research National Center of Surgery

Moscow, Russia

Location

Related Publications (1)

• 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.

  PMID: 38289301 DERIVED

Related 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

MeSH Terms

Conditions

Respiratory Insufficiency

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases

Study Officials

• Alexander А Eremenko, prof

  Head of the Intensive Care Unit

  STUDY DIRECTOR

• Darya Ryabova

  anesthesiologist-resuscitator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: November 17, 2021
• First Posted: December 16, 2021
• Study Start: January 18, 2022
• Primary Completion: May 14, 2023
• Study Completion: May 14, 2023
• Last Updated: August 23, 2023

Record last verified: 2023-08

Locations

RU (1)