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Completed

NCT Number: NCT05159401

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

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

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Key information

Conditions

Respiratory Failure Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Petrovsky Research National Center of Surgery

Moscow, Russia

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Primary outcomes

  1. the minute inspiratory lung volume

    Time frame: hospitalisation period, an average of 1 week

    Comparison of minute inspiratory lung volume befor/after research using a spirometer

  2. arterial blood oxygenation level

    Time frame: hospitalisation period, an average of 1 day

    Comparison arterial blood oxygenation level before/after researchin the study of arterial blood

  3. SpO2 more than 92%

    Time frame: hospitalisation period, an average of 3 day

    Comparison of SpO2 by pulse oximeter befor/after research (SpO2>92%)

Secondary outcomes

  1. the number of complications

    Time frame: hospitalisation period, an average of 1 week

    Comparison of the number of complications befor/after research

  2. assessment of the duration of hospital stay

    Time frame: hospitalisation period, an average of 1 week

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

Sponsors and collaborators

Lead sponsor

Petrovsky National Research Centre of Surgery

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Dec 16, 2021
Registry last updated
Aug 23, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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