"Barotrauma in Admitted Covid-19 Cases - A Single Center Retrospective Study"
NCT ID: NCT05216523
Last Updated: 2024-07-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
251 participants
OBSERVATIONAL
2021-06-24
2021-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Questionnaire Regarding the Effect of Wearing Face Masks on Oral Health
NCT04632004
Effect of Octreotide on Saliva
NCT05340192
Effect of Wearing Face Masks on Salivary Parameters and Halitosis
NCT04914208
Oral and Olfactory Complications of Recovered COVID-19 Patients
NCT04791436
Influence of Two Paraffin Wax Chewing Gums of Different Consistency on the Stimulated Saliva Flow Rate
NCT04661761
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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:
1. To study the incidence of barotrauma in hospitalized Covid-19 cases.
2. To find the association of factors inciting barotrauma.
3. 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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
CASE_CONTROL
RETROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Cases
Admitted Covid-19 cases who developed Barotrauma
No interventions assigned to this group
Controls
Admitted Covid-19 cases who did not develop Barotrauma, matched with Cases with respect to age and sex.
No interventions assigned to this group
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Those who developed barotrauma were labeled as "Cases" and those without barotrauma were "Controls".
Exclusion Criteria
* 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.
18 Years
89 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Sultan Qaboos University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Dr Jyoti Burad
Senior specialist
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jyoti Burad
Role: STUDY_DIRECTOR
Sultan Qaboos University Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Sultan Qaboos University Hospital
Muscat, , Oman
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
Kanne 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.
Supady 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.
Elhakim 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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
#2463
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.