SARS CoV 2 InfectionNCT05188482
Using Vibroacoustic Therapy in a Patient With Co-infection and COVID-19
An observational study of SARS CoV 2 Infection, run by Astana Medical University at 1 site in Kazakhstan.
Trial summary
This article describes a case of successful treatment of a 59-year-old man with sepsis as a result of periprosthetic infection against the background of severe SARS-CoV-2-19, who was hospitalized for 59 days, 57 of which were in the intensive care unit. Read more about this study
- Who is it for?
- Ages 59 to 59 years, men only
- Conditions the study is for
- SARS CoV 2 Infection
- What is being tested?
- vibroacoustic therapy
- Type of treatment
- Medical device
- How many people
- 1 participants
- Where
- 1 siteKazakhstan
- Study dates
- 29 Sep 2020to 1 Jan 2021
- How long will I take part?
- 1 Month
- Phase
- Observational
- 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 59 to 59 years
- Men only
- Adult
Study population: 59-year-old man with sepsis as a result of periprosthetic infection against the background of severe SARS-CoV-2-19,
Who may be able to join
- P/F less 300 torr
- COVID-19 Virus Infection
Who cannot join
- children
- acute stroke
- acute coronary syndrome
- DVT
- implanted pacemaker
- rib fracture
- infection on chest
Trial locations and contacts
1 site in 1 country.
Kazakhstan1 site
NATIONAL CENTER Scientific Center of Traumatology and Orthopedics named after Academician Batpenov N.D.
Astana, 010000
About this study
Official title: Complex Treatment Using Vibroacoustic Therapy in a Patient With Co-infection and COVID-19: Case Report.
This article describes a case of successful treatment of a 59-year-old man with sepsis as a result of periprosthetic infection against the background of severe SARS-CoV-2-19, who was hospitalized for 59 days, 57 of which were in the intensive care unit. Vibroacoustic pulmonary therapy, the concept of noninvasive ventilation, syndrome therapy, combination antibiotic therapy taking into account the pathogen and antibiotic sensitivity were used in the treatment.
Read the detailed description
During the pandemic caused by SARS-CoV-2-19, the whole world faced difficulties. Nevertheless, surgeons had to perform surgical treatment for patients who needed immediate help with a confirmed coronavirus infection [1, 2, 3].
Periprosthetic joint infection is a severe and undesirable consequence after arthroplasty [4, 5]. Patients with coronavirus infection and bacterial infection correlate with an unfavorable outcome [6, 7, 8] The effect of vibroacoustic therapy in the treatment of various conditions has not been sufficiently studied [9, 10]. This clinical case describes the complex therapy of a patient with a periprosthetic infection on the background of SARS-CoV-2 using a vibroacoustic pulmonary device.
- Conditions
- SARS CoV 2 Infection
- Being tested
- vibroacoustic therapy
- Keywords
- periprosthetic joint infection, SARS-CoV-2, co-infections, case report., vibroacoustic therapy
- Medical subject headings
- COVID-19, Coinfection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vibroacoustic therapyDevice
Vibroacoustic respiratory therapy
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of time spent on ventilation
Changing of the time spent by patients on mechanical ventilation
Measured: 1-2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start29 Sep 2020
- Primary completion25 Nov 2020
- Study completion1 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS CoV 2 InfectionStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 1 participants (actual)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- Astana Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05188482
- Sponsor's protocol ID
- MUA
- Status last verified
- Jan 2022
- First submitted
- 11 Jan 2022
- Last updated
- 12 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Complex Treatment Using Vibroacoustic Therapy in a Patient With Co-infection and COVID-19: Case Report.
- ClinicalTrials.gov ID
- NCT05188482
- Acronym / sponsor ID
- MUA
- Conditions
- SARS CoV 2 Infection
- Keywords
- periprosthetic joint infection, SARS-CoV-2, co-infections, case report., vibroacoustic therapy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- Astana Medical UniversityUniversity, hospital or other
- Study start
- 29 Sep 2020 (actual)
- Primary completion
- 25 Nov 2020 (actual)
- Study completion
- 1 Jan 2021 (actual)
- First posted
- 12 Jan 2022 (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.
This article describes a case of successful treatment of a 59-year-old man with sepsis as a result of periprosthetic infection against the background of severe SARS-CoV-2-19, who was hospitalized for 59 days, 57 of which were in the intensive care unit. Vibroacoustic pulmonary therapy, the concept of noninvasive ventilation, syndrome therapy, combination antibiotic therapy taking into account the pathogen and antibiotic sensitivity were used in the treatment.
Detailed description
During the pandemic caused by SARS-CoV-2-19, the whole world faced difficulties. Nevertheless, surgeons had to perform surgical treatment for patients who needed immediate help with a confirmed coronavirus infection [1, 2, 3].
Periprosthetic joint infection is a severe and undesirable consequence after arthroplasty [4, 5]. Patients with coronavirus infection and bacterial infection correlate with an unfavorable outcome [6, 7, 8] The effect of vibroacoustic therapy in the treatment of various conditions has not been sufficiently studied [9, 10]. This clinical case describes the complex therapy of a patient with a periprosthetic infection on the background of SARS-CoV-2 using a vibroacoustic pulmonary device.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Month
Who may qualify
- Ages
- 59 to 59 years
- Sex
- Male only
- Age groups
- Adult
- Study population
- 59-year-old man with sepsis as a result of periprosthetic infection against the background of severe SARS-CoV-2-19,
Key inclusion criteria (2 listed)
- P/F less 300 torr
- COVID-19 Virus Infection
Key exclusion criteria (7 listed)
- children
- acute stroke
- acute coronary syndrome
- DVT
- implanted pacemaker
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 |
|---|---|---|
| vibroacoustic therapyVibroacoustic respiratory therapy | Device | – |
Primary outcome
Change of time spent on ventilation
Time frame: 1-2 days
Changing of the time spent by patients on mechanical ventilation
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 12 Jan 2022.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of SARS CoV 2 Infection, run by Astana Medical University at 1 site in Kazakhstan.
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 2 inclusion and 7 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 12 Jan 2022. 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 Kazakhstan. 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?
Change of time spent on ventilation (time frame: 1-2 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 Jan 2022.