BarotraumaBARCOVNCT05216523
"Barotrauma in Admitted Covid-19 Cases - A Single Center Retrospective Study"
An observational study of Barotrauma and COVID-19, run by Sultan Qaboos University at 1 site in Oman.
Trial summary
A retrospective study is planned to find out the incidence and association type of respiratory support with barotrauma in Covid-19 cases admitted in Sultan Qaboos University Hospital. As widely known, Covid-19 affects the respiratory system primarily and is the main cause of admission to hospital. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Barotrauma, COVID-19
- How many people
- 251 participants
- Where
- 1 siteOman
- Study dates
- 24 Jun 2021to 30 Nov 2021
- 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 18 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A total of 2159 Covid-19 PCR-positive patients were identified in consecutive participant sampling at the University hospital during the study period. Out of these 63 patients were found to develop barotrauma. Matched controls were identified and a total of 322 cases was scanned. 61 patients were discharged from the emergency department after initial treatment, 1 patient left against medical advice and 2 patients died before they could be admitted to the ward and 7 were shifted to other hospitals, and their follow-up was lost, hence a total of 251 patients were finally studied. 63 patients were "Cases" and 188 were "Controls" in the ratio of 1:3 cases: controls.
Who may be able to join
- All admitted adult patients with covid PCR positive result
- Those who developed barotrauma were labeled as "Cases" and those without barotrauma were "Controls".
Who cannot join
- Adult patients with covid PCR positive result who were discharged from Emergency department.
- Adult patients with covid PCR positive result who died or left against medical advice before admission to ward/ICU
- Adult patients with covid PCR positive result who were shifted to other hospitals and their follow up could not be completed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: "Review of Barotrauma in Admitted Covid-19 Cases - A Single Center Retrospective Study From March 2020 Till April 2021."
A retrospective study is planned to find out the incidence and association type of respiratory support with barotrauma in Covid-19 cases admitted in Sultan Qaboos University Hospital. As widely known, Covid-19 affects the respiratory system primarily and is the main cause of admission to hospital. Depending upon the severity, different levels of respiratory support are offered to the patients. Normally patients with viral/bacterial respiratory diseases have a low incidence of barotrauma. Since this disease is new and it has been observed that a significant number of covid-19 patients develop barotrauma, hence it is deemed worthwhile to investigate the matter.
All the patients admitted to the ward, high dependency unit, and intensive care unit will be scanned and those who developed barotrauma (pneumothorax, surgical emphysema, pneumo-pericardium, and pneumo-mediastinum) will be studied in detail and analyzed.
This review is expected to highlight the problem and etiology and we might be able to suggest a management strategy to deal with this problem.
Read the detailed description
Introduction
Covid-19 is a recently emerged disease affecting the respiratory system primarily but later on, progresses to multisystem involvement. Most of the cases are mild and self-remitting. However, those who develop moderate to severe symptoms require admission. They receive different modalities of respiratory support as per the international guidelines.
The covid-19 typically starts with mild respiratory symptoms with fever, headache, and myalgia. Most of the cases remit after these by 10 days, but around 15% progress to more severe symptoms such as worsening of fever, respiratory symptoms leading to hypoxemia proceeding to complications further on. Correspondingly, the radiological findings peak by 2 weeks after symptom onset. By this point in time, the patients start requiring respiratory support and complications start to emerge as the time passes. Bacterial superinfections, interleukin surge, septic shock are commonly encountered. Recently, at our center rising episodes of barotrauma have been observed.
In the covid era because of huge numbers of admissions, the hospital, as well as ICU beds with respiratory and monitoring resources, are becoming significantly scarce. Hence prevention of complications can have a great impact on improving patient outcomes and utilizing hospital resources.
There can be few recognized mechanisms of barotrauma in Covid-19 cases. One of them is alveolar overdistension leading to rupture and barotrauma and the second is a decrease in the caliber of pulmonary vessels increasing pressure gradient causing air leak to the sheath. Positive pressure ventilation leads to an increase in intra-alveolar alveoli. Macklin phenomenon also describes the occurrence of a large pressure gradient between marginal alveoli and lung interstitium leading to barotrauma.
Barotrauma is treated by intercostal drain insertion, as well as conservative management by the reduction in airway pressures and increase in oxygen supplementation. Both these can lead to setbacks in a patient's recovery.
This research will identify the etiology of barotrauma and will highlight the preventive strategy to deal with it.
Aim of the Study:
This study aims to examine the incidence of barotrauma, its association with different management strategies so as to suggest modification of preventive and inciting factors. This may improve patient outcomes and conserve hospital resources.
Specific objectives:
- To study the incidence of barotrauma in hospitalized Covid-19 cases.
- To find the association of factors inciting barotrauma.
- To formulate a management plan for the prevention of barotrauma in these cases.
Methodology and study design:
This retrospective study will be conducted in the Department of Anesthesia and ICU at Sultan Qaboos University hospital (SQUH) situated in Muscat, Oman. All admitted patients of Covid-19/SARS-2 between March 2020 to April 2021 will be scanned in the computerized system with the keywords: barotrauma, pneumothorax, surgical emphysema, pneumo-pericardium, and pneumo-mediastinum. A list of cases with these problems will be obtained and the cases will be studied in detail. Data will be obtained from SQUH "Track Care" hospital information system.
Study Population:
Inclusions:
● All admitted patients of Covid-19/SARS-2 between March 2020 to April 2021 t SQUH
Exclusions:
● Patients who develop barotrauma due to central line insertion or trauma prior to admission.
Data Collection and Analyses:
Demographic details, Day of barotrauma, comorbidities, type of respiratory support, other treatment modalities, and covid laboratory profile: ferritin, LDH, CRP, IL-6, fibrinogen, white cell count, and lymphocyte counts.
SPSS software (version 23) will be used to collect and analyze data. Obtaining the significance of association will be through using students' t-test, fisher's exact test, and Chi-square test. P-value < 0.05 will be considered significant.
- Conditions
- Barotrauma, COVID-19
- Keywords
- Barotrauma, COVID-19, positive pressure ventilation, ferritin, steroids
- Medical subject headings
- Barotrauma, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cases | Admitted Covid-19 cases who developed Barotrauma | |
| Controls | Admitted Covid-19 cases who did not develop Barotrauma, matched with Cases with respect to age and sex. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Barotrauma in admitted Covid-19 cases
Incidence of Barotrauma in admitted Covid-19 cases between March 2020 till April 2021
Measured: 1-102 days
Secondary outcomes (3)
Association of factors with Barotrauma in admitted Covid-19 cases
Association of factors with Barotrauma in admitted Covid-19 cases
Measured: 1-102 days
Mortality with cases versus controls
Mortality with cases versus controls
Measured: 1-102 days
Ventilation days of cases versus controls
Ventilation days
Measured: 1-65 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jan 2022
- Study start24 Jun 2021
- Primary completion30 Nov 2021
- Study completion30 Nov 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for BarotraumaStudies 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
- Retrospective
- Enrolment
- 251 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sultan Qaboos University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Jyoti Burad, Sultan Qaboos University
- Investigators
- Jyoti Burad, Study director, Sultan Qaboos University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05216523
- Sponsor's protocol ID
- #2463
- Acronym
- BARCOV
- Status last verified
- Jul 2024
- First submitted
- 28 Jan 2022
- Last updated
- 10 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD might be made available on individual request
Publications
Pascarella G, Strumia A, Piliego C, Bruno F, Del Buono R, Costa F, Scarlata S, Agro FE. COVID-19 diagnosis and management: a comprehensive review. J Intern Med. 2020 Aug;288(2):192-206. doi: 10.1111/joim.13091. Epub 2020 May 13.
PubMed 32348588Kanne JP, Bai H, Bernheim A, Chung M, Haramati LB, Kallmes DF, Little BP, Rubin GD, Sverzellati N. COVID-19 Imaging: What We Know Now and What Remains Unknown. Radiology. 2021 Jun;299(3):E262-E279. doi: 10.1148/radiol.2021204522. Epub 2021 Feb 9.
PubMed 33560192Supady A, Curtis JR, Abrams D, Lorusso R, Bein T, Boldt J, Brown CE, Duerschmied D, Metaxa V, Brodie D. Allocating scarce intensive care resources during the COVID-19 pandemic: practical challenges to theoretical frameworks. Lancet Respir Med. 2021 Apr;9(4):430-434. doi: 10.1016/S2213-2600(20)30580-4. Epub 2021 Jan 12.
PubMed 33450202Elhakim TS, Abdul HS, Pelaez Romero C, Rodriguez-Fuentes Y. Spontaneous pneumomediastinum, pneumothorax and subcutaneous emphysema in COVID-19 pneumonia: a rare case and literature review. BMJ Case Rep. 2020 Dec 12;13(12):e239489. doi: 10.1136/bcr-2020-239489.
PubMed 33310838
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- "Review of Barotrauma in Admitted Covid-19 Cases - A Single Center Retrospective Study From March 2020 Till April 2021."
- ClinicalTrials.gov ID
- NCT05216523
- Acronym / sponsor ID
- BARCOV / #2463
- Conditions
- Barotrauma, COVID-19
- Keywords
- Barotrauma, COVID-19, positive pressure ventilation, ferritin, steroids
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 251 participants (actual)
- Lead sponsor
- Sultan Qaboos UniversityUniversity, hospital or other
- Study start
- 24 Jun 2021 (actual)
- Primary completion
- 30 Nov 2021 (actual)
- Study completion
- 30 Nov 2021 (actual)
- First posted
- 31 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.
A retrospective study is planned to find out the incidence and association type of respiratory support with barotrauma in Covid-19 cases admitted in Sultan Qaboos University Hospital. As widely known, Covid-19 affects the respiratory system primarily and is the main cause of admission to hospital. Depending upon the severity, different levels of respiratory support are offered to the patients. Normally patients with viral/bacterial respiratory diseases have a low incidence of barotrauma. Since this disease is new and it has been observed that a significant number of covid-19 patients develop barotrauma, hence it is deemed worthwhile to investigate the matter.
All the patients admitted to the ward, high dependency unit, and intensive care unit will be scanned and those who developed barotrauma (pneumothorax, surgical emphysema, pneumo-pericardium, and pneumo-mediastinum) will be studied in detail and analyzed.
This review is expected to highlight the problem and etiology and we might be able to suggest a management strategy to deal with this problem.
Detailed description
Introduction
Covid-19 is a recently emerged disease affecting the respiratory system primarily but later on, progresses to multisystem involvement. Most of the cases are mild and self-remitting. However, those who develop moderate to severe symptoms require admission. They receive different modalities of respiratory support as per the international guidelines.
The covid-19 typically starts with mild respiratory symptoms with fever, headache, and myalgia. Most of the cases remit after these by 10 days, but around 15% progress to more severe symptoms such as worsening of fever, respiratory symptoms leading to hypoxemia proceeding to complications further on. Correspondingly, the radiological findings peak by 2 weeks after symptom onset. By this point in time, the patients start requiring respiratory support and complications start to emerge as the time passes. Bacterial superinfections, interleukin surge, septic shock are commonly encountered. Recently, at our center rising episodes of barotrauma have been observed.
In the covid era because of huge numbers of admissions, the hospital, as well as ICU beds with respiratory and monitoring resources, are becoming significantly scarce. Hence prevention of complications can have a great impact on improving patient outcomes and utilizing hospital resources.
There can be few recognized mechanisms of barotrauma in Covid-19 cases. One of them is alveolar overdistension leading to rupture and barotrauma and the second is a decrease in the caliber of pulmonary vessels increasing pressure gradient causing air leak to the sheath. Positive pressure ventilation leads to an increase in intra-alveolar alveoli. Macklin phenomenon also describes the occurrence of a large pressure gradient between marginal alveoli and lung interstitium leading to barotrauma.
Barotrauma is treated by intercostal drain insertion, as well as conservative management by the reduction in airway pressures and increase in oxygen supplementation. Both these can lead to setbacks in a patient's recovery.
This research will identify the etiology of barotrauma and will highlight the preventive strategy to deal with it.
Aim of the Study:
This study aims to examine the incidence of barotrauma, its association with different management strategies so as to suggest modification of preventive and inciting factors. This may improve patient outcomes and conserve hospital resources.
Specific objectives:
- To study the incidence of barotrauma in hospitalized Covid-19 cases.
- To find the association of factors inciting barotrauma.
- To formulate a management plan for the prevention of barotrauma in these cases.
Methodology and study design:
This retrospective study will be conducted in the Department of Anesthesia and ICU at Sultan Qaboos University hospital (SQUH) situated in Muscat, Oman. All admitted patients of Covid-19/SARS-2 between March 2020 to April 2021 will be scanned in the computerized system with the keywords: barotrauma, pneumothorax, surgical emphysema, pneumo-pericardium, and pneumo-mediastinum. A list of cases with these problems will be obtained and the cases will be studied in detail. Data will be obtained from SQUH "Track Care" hospital information system.
Study Population:
Inclusions:
● All admitted patients of Covid-19/SARS-2 between March 2020 to April 2021 t SQUH
Exclusions:
● Patients who develop barotrauma due to central line insertion or trauma prior to admission.
Data Collection and Analyses:
Demographic details, Day of barotrauma, comorbidities, type of respiratory support, other treatment modalities, and covid laboratory profile: ferritin, LDH, CRP, IL-6, fibrinogen, white cell count, and lymphocyte counts.
SPSS software (version 23) will be used to collect and analyze data. Obtaining the significance of association will be through using students' t-test, fisher's exact test, and Chi-square test. P-value < 0.05 will be considered significant.
Study design
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cases | – | –Admitted Covid-19 cases who developed Barotrauma |
| Controls | – | –Admitted Covid-19 cases who did not develop Barotrauma, matched with Cases with respect to age and sex. |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A total of 2159 Covid-19 PCR-positive patients were identified in consecutive participant sampling at the University hospital during the study period. Out of these 63 patients were found to develop barotrauma. Matched controls were identified and a total of 322 cases was scanned. 61 patients were discharged from the emergency department after initial treatment, 1 patient left against medical advice and 2 patients died before they could be admitted to the ward and 7 were shifted to other hospitals, and their follow-up was lost, hence a total of 251 patients were finally studied. 63 patients were "Cases" and 188 were "Controls" in the ratio of 1:3 cases: controls.
Key inclusion criteria (2 listed)
- All admitted adult patients with covid PCR positive result
- Those who developed barotrauma were labeled as "Cases" and those without barotrauma were "Controls".
Key exclusion criteria (3 listed)
- Adult patients with covid PCR positive result who were discharged from Emergency department.
- Adult patients with covid PCR positive result who died or left against medical advice before admission to ward/ICU
- Adult patients with covid PCR positive result who were shifted to other hospitals and their follow up could not be completed.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of Barotrauma in admitted Covid-19 cases
Time frame: 1-102 days
Incidence of Barotrauma in admitted Covid-19 cases between March 2020 till April 2021
3 secondary outcomes
Association of factors with Barotrauma in admitted Covid-19 cases
Time frame: 1-102 days
Mortality with cases versus controls
Time frame: 1-102 days
Ventilation days of cases versus controls
Time frame: 1-65 days
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 10 Jul 2024.
- Background: PubMed 32348588Pascarella G, Strumia A, Piliego C, Bruno F, Del Buono R, Costa F, Scarlata S, Agro FE. COVID-19 diagnosis and management: a comprehensive review. J Intern Med. 2020 Aug;288(2):192-206. doi: 10.1111/joim.13091. Epub 2020 May 13.
- Background: PubMed 33560192Kanne JP, Bai H, Bernheim A, Chung M, Haramati LB, Kallmes DF, Little BP, Rubin GD, Sverzellati N. COVID-19 Imaging: What We Know Now and What Remains Unknown. Radiology. 2021 Jun;299(3):E262-E279. doi: 10.1148/radiol.2021204522. Epub 2021 Feb 9.
- Background: PubMed 33450202Supady A, Curtis JR, Abrams D, Lorusso R, Bein T, Boldt J, Brown CE, Duerschmied D, Metaxa V, Brodie D. Allocating scarce intensive care resources during the COVID-19 pandemic: practical challenges to theoretical frameworks. Lancet Respir Med. 2021 Apr;9(4):430-434. doi: 10.1016/S2213-2600(20)30580-4. Epub 2021 Jan 12.
- Background: PubMed 33310838Elhakim TS, Abdul HS, Pelaez Romero C, Rodriguez-Fuentes Y. Spontaneous pneumomediastinum, pneumothorax and subcutaneous emphysema in COVID-19 pneumonia: a rare case and literature review. BMJ Case Rep. 2020 Dec 12;13(12):e239489. doi: 10.1136/bcr-2020-239489.
- Individual participant dataSharing planned: Undecided. IPD might be made available on individual request
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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.
Jyoti Burad study director
Sultan Qaboos University Hospital
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 Barotrauma and COVID-19, run by Sultan Qaboos University at 1 site in Oman.
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 3 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 10 Jul 2024. 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 Oman. 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?
Incidence of Barotrauma in admitted Covid-19 cases (time frame: 1-102 days). 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 NCT05216523, which also lists 4 linked publications.
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 10 Jul 2024.