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

Primary Purpose

Respiratory Failure

Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
prevention of respiratory failure
Sponsored by
Petrovsky National Research Centre of Surgery
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Respiratory Failure focused on measuring medical rehabilitation; oxygenation

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Petrovsky Research National Center of Surgery

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

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

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)

the fourth group:classical manual chest massage with percussion

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

the minute inspiratory lung volume
Comparison of minute inspiratory lung volume befor/after research using a spirometer
arterial blood oxygenation level
Comparison arterial blood oxygenation level before/after researchin the study of arterial blood
SpO2 more than 92%
Comparison of SpO2 by pulse oximeter befor/after research (SpO2>92%)

Secondary Outcome Measures

the number of complications
Comparison of the number of complications befor/after research
assessment of the duration of hospital stay
Comparison of assessment of the duration of hospital stay befor/after research

Full Information

First Posted
November 17, 2021
Last Updated
August 18, 2023
Sponsor
Petrovsky National Research Centre of Surgery
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1. Study Identification

Unique Protocol Identification Number
NCT05159401
Brief Title
The Use of Vibrational Methods of Influencing the Lungs to Restore Their Functional State
Official Title
The Use of Vibrational Methods of Influencing the Lungs to Restore Their Functional State After Major Reconstructive Cardiac Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Completed
Study Start Date
January 18, 2022 (Actual)
Primary Completion Date
May 14, 2023 (Actual)
Study Completion Date
May 14, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Petrovsky National Research Centre of Surgery

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Respiratory Failure
Keywords
medical rehabilitation; oxygenation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Factorial Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
the first group: the method of vibroacoustic lung massage using the "BARK VibroLUNG" device
Arm Type
Experimental
Arm Description
dynamics blood saturation by pulse oximeter,minute inspiratory lung volume befor/after research
Arm Title
the second group:the method of oscillating REР therapy using Acapella DH Green
Arm Type
Experimental
Arm Description
dynamics blood saturation by pulse oximeter,minute inspiratory lung volume befor/after research
Arm Title
the third group:the method of hardware stimulation of cough (Comfortable cough Plus)
Arm Type
Experimental
Arm Description
dynamics blood saturation by pulse oximeter,minute inspiratory lung volume befor/after research
Arm Title
the fourth group:classical manual chest massage with percussion
Arm Type
Experimental
Arm Description
dynamics blood saturation by pulse oximeter,minute inspiratory lung volume befor/after research
Intervention Type
Procedure
Intervention Name(s)
prevention of respiratory failure
Intervention Description
Positive dynamics during CT or X-ray examinations in the form of reduction of hypoventilation zones, straightening of lung tissue
Primary Outcome Measure Information:
Title
the minute inspiratory lung volume
Description
Comparison of minute inspiratory lung volume befor/after research using a spirometer
Time Frame
hospitalisation period, an average of 1 week
Title
arterial blood oxygenation level
Description
Comparison arterial blood oxygenation level before/after researchin the study of arterial blood
Time Frame
hospitalisation period, an average of 1 day
Title
SpO2 more than 92%
Description
Comparison of SpO2 by pulse oximeter befor/after research (SpO2>92%)
Time Frame
hospitalisation period, an average of 3 day
Secondary Outcome Measure Information:
Title
the number of complications
Description
Comparison of the number of complications befor/after research
Time Frame
hospitalisation period, an average of 1 week
Title
assessment of the duration of hospital stay
Description
Comparison of assessment of the duration of hospital stay befor/after research
Time Frame
hospitalisation period, an average of 1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexander А Eremenko, prof
Organizational Affiliation
Head of the Intensive Care Unit
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Darya Ryabova
Organizational Affiliation
anesthesiologist-resuscitator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Petrovsky Research National Center of Surgery
City
Moscow
Country
Russian Federation

12. IPD Sharing Statement

Links:
URL
http://pubmed.ncbi.nlm.nih.gov/34965710/
Description
Effectiveness and safety evaluation of a cough stimulation device in early postoperative respiratory rehabilitation in cardiac surgery patients
URL
http://www.mediasphera.ru/issues/kardiologiya-i-serdechno-sosudistaya-khirurgiya/2021/6/downloads/ru/1199663852021061477
Description
Effectiveness of oscillating PEP-therapy in early period after cardiac surgery
URL
http://www.vair-journal.com/jour/article/view/603
Description
Comparative Evaluation of Vibratory Physiotherapy Methods in the Early Period after Cardiac Surgery
URL
http://www.reanimatology.com/rmt/article/view/2256/1704
Description
Comparing the Inspiratory Capacity Measurements Obtained by Incentive Spirometry and Ultrasonic Spirography in the Early Postoperative Period in Cardiac Surgery Patients
URL
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC9579221/pdf/40635_2022_Article_468.pdf
Description
poster report with publication Intensive Care Medicine Experimental. ESICM 2022. 000290
URL
http://ccforum.biomedcentral.com/counter/pdf/10.1186/s13054-023-04377-x.pdf
Description
poster report with publication Critical Care. 42nd International Symposium on Intensive Care & Emergency Medicine. P330

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

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