Respiratory FailureNCT05159401
The Use of Vibrational Methods of Influencing the Lungs to Restore Their Functional State
A study testing prevention of respiratory failure in people with Respiratory Failure, run by Petrovsky National Research Centre of Surgery at 1 site in Russia.
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… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Respiratory Failure
- What is being tested?
- prevention of respiratory failure
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 1 siteRussia
- Study dates
- 18 Jan 2022to 14 May 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age from 18 years to 80 years inclusive.
- Performed cardiac surgery in IC conditions.
- The patient's consent to participate in this study.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
Read the 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
- Conditions
- Respiratory Failure
- Being tested
- prevention of respiratory failure
- Keywords
- medical rehabilitation; oxygenation
- Medical subject headings
- Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
prevention of respiratory failureProcedure or surgery
Positive dynamics during CT or X-ray examinations in the form of reduction of hypoventilation zones, straightening of lung tissue
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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 Receives: Procedure: prevention of respiratory failure |
What is being measured
The primary outcome is the main question the study is designed to answer.
the minute inspiratory lung volume
Comparison of minute inspiratory lung volume befor/after research using a spirometer
Measured: hospitalisation period, an average of 1 week
arterial blood oxygenation level
Comparison arterial blood oxygenation level before/after researchin the study of arterial blood
Measured: hospitalisation period, an average of 1 day
SpO2 more than 92%
Comparison of SpO2 by pulse oximeter befor/after research (SpO2>92%)
Measured: hospitalisation period, an average of 3 day
Secondary outcomes (2)
the number of complications
Comparison of the number of complications befor/after research
Measured: 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
Measured: hospitalisation period, an average of 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2021
- Study start18 Jan 2022
- Primary completion14 May 2023
- Study completion14 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Respiratory FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 240 participants (actual)
Sponsor and investigators
- Lead sponsor
- Petrovsky National Research Centre of Surgery
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aleksandr Eremenko, Petrovsky National Research Centre of Surgery
- Investigators
- Alexander А Eremenko, prof, Study director, Head of the Intensive Care UnitDarya Ryabova, Principal investigator, anesthesiologist-resuscitator
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05159401
- Sponsor's protocol ID
- 09052021
- Status last verified
- Aug 2023
- First submitted
- 17 Nov 2021
- Last updated
- 23 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38289301
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Use of Vibrational Methods of Influencing the Lungs to Restore Their Functional State After Major Reconstructive Cardiac Surgery
- ClinicalTrials.gov ID
- NCT05159401
- Acronym / sponsor ID
- 09052021
- Conditions
- Respiratory Failure
- Keywords
- medical rehabilitation; oxygenation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 240 participants (actual)
- Lead sponsor
- Petrovsky National Research Centre of SurgeryUniversity, hospital or other
- Study start
- 18 Jan 2022 (actual)
- Primary completion
- 14 May 2023 (actual)
- Study completion
- 14 May 2023 (actual)
- First posted
- 16 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| the first group: the method of vibroacoustic lung massage using the "BARK VibroLUNG" device | Experimental | Procedure: prevention of respiratory failuredynamics blood saturation by pulse oximeter,minute inspiratory lung volume befor/after research |
| the second group:the method of oscillating REР therapy using Acapella DH Green | Experimental | Procedure: prevention of respiratory failuredynamics blood saturation by pulse oximeter,minute inspiratory lung volume befor/after research |
| the third group:the method of hardware stimulation of cough (Comfortable cough Plus) | Experimental | Procedure: prevention of respiratory failuredynamics blood saturation by pulse oximeter,minute inspiratory lung volume befor/after research |
| the fourth group:classical manual chest massage with percussion | Experimental | Procedure: prevention of respiratory failuredynamics blood saturation by pulse oximeter,minute inspiratory lung volume befor/after research |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age from 18 years to 80 years inclusive.
- Performed cardiac surgery in IC conditions.
- The patient's consent to participate in this study.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| prevention of respiratory failurePositive dynamics during CT or X-ray examinations in the form of reduction of hypoventilation zones, straightening of lung tissue | Procedure or surgery | 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) |
Primary outcome
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
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
SpO2 more than 92%
Time frame: hospitalisation period, an average of 3 day
Comparison of SpO2 by pulse oximeter befor/after research (SpO2>92%)
2 secondary outcomes
the number of complications
Time frame: hospitalisation period, an average of 1 week
assessment of the duration of hospital stay
Time frame: hospitalisation period, an average of 1 week
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2023.
- Derived from this study: PubMed 38289301Eremenko 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.
- Effectiveness and safety evaluation of a cough stimulation device in early postoperative respiratory rehabilitation in cardiac surgery patientsLink provided by the sponsor.
- Effectiveness of oscillating PEP-therapy in early period after cardiac surgeryLink provided by the sponsor.
- Comparative Evaluation of Vibratory Physiotherapy Methods in the Early Period after Cardiac SurgeryLink provided by the sponsor.
- Comparing the Inspiratory Capacity Measurements Obtained by Incentive Spirometry and Ultrasonic Spirography in the Early Postoperative Period in Cardiac Surgery PatientsLink provided by the sponsor.
- poster report with publication Intensive Care Medicine Experimental. ESICM 2022. 000290Link provided by the sponsor.
- poster report with publication Critical Care. 42nd International Symposium on Intensive Care \& Emergency Medicine. P330Link provided by the sponsor.
Related trials for Respiratory Failure
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
Not yet recruiting
Regional Lung Ventilation During Prone Position in in Intubated Children
Pediatric Acute Respiratory Failure
Not yet recruiting
Smartphone Camera Measurement of Breathing-Related Heart Rate Variability Compared With ECG in Healthy Adults
Respiratory Sinus Arrhythmia, Heart Rate Variability
Not yet recruiting
Mechanical Ventilator Adjustments and Patient Dyspnea
Respiratory Failure, Dyspnea During Mechanical Ventilation
Not yet recruitingObservational study
Clinical Genetics Branch Eligibility Screening Survey
Melanoma, Li-Fraumeni Syndrome
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexander А Eremenko, prof study director
Head of the Intensive Care Unit
Darya Ryabova principal investigator
anesthesiologist-resuscitator
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing prevention of respiratory failure in people with Respiratory Failure, run by Petrovsky National Research Centre of Surgery at 1 site in Russia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the minute inspiratory lung volume (time frame: hospitalisation period, an average of 1 week). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05159401, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2023.