- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05067881
Post-COVID-19 Pneumo-hematocele (PHC)
Post COVID-19 Pneumo-hematocele: Clinical Presentation and Treatment Pathway
Introduction. As the COVID-19 pandemic has continued, an increasing number of long-term complications are emerging. Recently, the appearance of characteristic pulmonary lesions has been noted, being described as post COVID-19 pneumatocele. The aim of this study is to describe the clinical, histopathologic and imaging features of post COVID-19 pneumo-hematoceles (PHC) and secondarily to suggest a treatment algorithm in these patients.
Methods. A retrospective study was performed in patients admitted with diagnosis of SARS-CoV2 infection from March 2020 to September 2021 who presented PHC on imaging studies. Clinical and demographic variables were recorded and CT scans were analyzed. A logistic regression analysis was performed to determine the risk for rupture according to PHC characteristics.
It appears that PHC occurs secondary to encapsulation of blood accumulation, the result of micro capillary bleeding, with partial reabsorption of blood and subsequent air filling. The recommendation is to operate on patients with PHC of 5cm and those with persistent lesions of 3cm.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
-
Mexico City, Mexico, 14500
- Karla Verónica Chávez Tostado
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Adults with a positive protein chain reaction for SARS-CoV2,
- PHC on imaging studies.
Exclusion Criteria:
- loss of follow up
- age out of range.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Pneumohematocele
Patients with SARS CoV-2 diagnosis and PHC on imaging studies
|
Resection of pneumohematocele
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
PHC diagnosis
Time Frame: From date of diagnosis until 4 weeks after diagnosis
|
Pneumohematoceles on imaging studies
|
From date of diagnosis until 4 weeks after diagnosis
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Karla V Chavez Tostado, MD, Head of surgery department
Publications and helpful links
General Publications
- Inciardi RM, Lupi L, Zaccone G, Italia L, Raffo M, Tomasoni D, Cani DS, Cerini M, Farina D, Gavazzi E, Maroldi R, Adamo M, Ammirati E, Sinagra G, Lombardi CM, Metra M. Cardiac Involvement in a Patient With Coronavirus Disease 2019 (COVID-19). JAMA Cardiol. 2020 Jul 1;5(7):819-824. doi: 10.1001/jamacardio.2020.1096.
- Bernheim A, Mei X, Huang M, Yang Y, Fayad ZA, Zhang N, Diao K, Lin B, Zhu X, Li K, Li S, Shan H, Jacobi A, Chung M. Chest CT Findings in Coronavirus Disease-19 (COVID-19): Relationship to Duration of Infection. Radiology. 2020 Jun;295(3):200463. doi: 10.1148/radiol.2020200463. Epub 2020 Feb 20.
- Hansell DM, Bankier AA, MacMahon H, McLoud TC, Muller NL, Remy J. Fleischner Society: glossary of terms for thoracic imaging. Radiology. 2008 Mar;246(3):697-722. doi: 10.1148/radiol.2462070712. Epub 2008 Jan 14.
- Maury A, Lyoubi A, Peiffer-Smadja N, de Broucker T, Meppiel E. Neurological manifestations associated with SARS-CoV-2 and other coronaviruses: A narrative review for clinicians. Rev Neurol (Paris). 2021 Jan-Feb;177(1-2):51-64. doi: 10.1016/j.neurol.2020.10.001. Epub 2020 Dec 16.
- Ho JS, Sia CH, Chan MY, Lin W, Wong RC. Coronavirus-induced myocarditis: A meta-summary of cases. Heart Lung. 2020 Nov-Dec;49(6):681-685. doi: 10.1016/j.hrtlng.2020.08.013. Epub 2020 Aug 20.
- Chen X, Laurent S, Onur OA, Kleineberg NN, Fink GR, Schweitzer F, Warnke C. A systematic review of neurological symptoms and complications of COVID-19. J Neurol. 2021 Feb;268(2):392-402. doi: 10.1007/s00415-020-10067-3. Epub 2020 Jul 20.
- Ojo AS, Balogun SA, Williams OT, Ojo OS. Pulmonary Fibrosis in COVID-19 Survivors: Predictive Factors and Risk Reduction Strategies. Pulm Med. 2020 Aug 10;2020:6175964. doi: 10.1155/2020/6175964. eCollection 2020.
- Gentile F, Aimo A, Forfori F, Catapano G, Clemente A, Cademartiri F, Emdin M, Giannoni A. COVID-19 and risk of pulmonary fibrosis: the importance of planning ahead. Eur J Prev Cardiol. 2020 Sep;27(13):1442-1446. doi: 10.1177/2047487320932695. Epub 2020 Jun 17. No abstract available.
- Sun R, Liu H, Wang X. Mediastinal Emphysema, Giant Bulla, and Pneumothorax Developed during the Course of COVID-19 Pneumonia. Korean J Radiol. 2020 May;21(5):541-544. doi: 10.3348/kjr.2020.0180. Epub 2020 Mar 20.
- Sato L, Kinoshita N, Nakamoto T, Ohmagari N. Hemoptysis and a Newly Formed Lung Bulla in a Case of Convalescent COVID-19 Pneumonia. Intern Med. 2021 Mar 1;60(5):803-805. doi: 10.2169/internalmedicine.5684-20. Epub 2021 Jan 15.
- Xu W, Luo X, Wang H, Shen C, Song Y, Sun T, Chen M. Pulmonary emphysema, bullae, and pneumothorax in COVID-19 pneumonia. Radiol Case Rep. 2021 May;16(5):995-998. doi: 10.1016/j.radcr.2021.01.055. Epub 2021 Jan 31.
- Sanivarapu RR, Farraj K, Sayedy N, Anjum F. Rapidly developing large pneumatocele and spontaneous pneumothorax in SARS-CoV-2 infection. Respir Med Case Rep. 2020;31:101303. doi: 10.1016/j.rmcr.2020.101303. Epub 2020 Dec 2.
- Hamad AM, El-Saka HA. Post COVID-19 large pneumatocele: clinical and pathological perspectives. Interact Cardiovasc Thorac Surg. 2021 Jul 26;33(2):322-324. doi: 10.1093/icvts/ivab072.
- Jamil A, Kasi A. Pneumatocele. 2022 Aug 8. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2022 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK556146/
- Desrues B, Delaval P, Motreff C, Kernec J, Dormoy C, Pencole C, Bergeron D, Malledan Y, Saint-Marc C. [Post-traumatic pneumatocele and hemato-pneumatocele of the lung. Apropos of 3 cases]. Rev Mal Respir. 1988;5(1):67-70. French.
- Kaira K, Ishizuka T, Yanagitani N, Sunaga N, Hisada T, Mori M. Pulmonary traumatic pneumatocele and hematoma. Jpn J Radiol. 2009 Feb;27(2):100-2. doi: 10.1007/s11604-008-0296-x. Epub 2009 Mar 12.
- Al-Ghafri M, Al-Hanshi S, Al-Ismaily S. Two Cases of Pneumatoceles in Mechanically Ventilated Infants. Oman Med J. 2015 Jul;30(4):299-302. doi: 10.5001/omj.2015.59.
- Liu K, Zeng Y, Xie P, Ye X, Xu G, Liu J, Wang H, Qian J. COVID-19 with cystic features on computed tomography: A case report. Medicine (Baltimore). 2020 May;99(18):e20175. doi: 10.1097/MD.0000000000020175.
- Purdy GD, Cullen M, Yedlin S, Bedard MP. An unusual neonatal case presentation: Streptococcus pneumoniae pneumonia with abscess and pneumatocele formation. J Perinatol. 1987 Fall;7(4):378-81. No abstract available.
- Ishiguchi S, Nishioka K, Kanetake Y, Sugiyama K, Shibayama M. [Pneumatocele accompanying staphylococcal pneumonia]. Rinsho Hoshasen. 1966 Aug;11(8):644-53. No abstract available. Japanese.
- Sandhu JS, Goodman PC. Pulmonary cysts associated with Pneumocystis carinii pneumonia in patients with AIDS. Radiology. 1989 Oct;173(1):33-5. doi: 10.1148/radiology.173.1.2789413.
- Murayama D, Kojima D, Hino A, Yamamoto Y, Doiuchi T, Horikawa A, Kurihara H. A case of bulla formation after treatment for COVID-19 pneumonia. Radiol Case Rep. 2021 May;16(5):1162-1164. doi: 10.1016/j.radcr.2021.03.003. Epub 2021 Mar 10. Erratum In: Radiol Case Rep. 2022 Sep 29;17(12):4933.
- Capleton P, Ricketts W, Lau K, Ellis S, Sheaff M, Giaslakiotis K, Uys S, Tchrakian N. Pneumothorax and Pneumatocoele Formation in a Patient with COVID-19: a Case Report. SN Compr Clin Med. 2021;3(1):269-272. doi: 10.1007/s42399-020-00689-z. Epub 2021 Jan 7.
- Fan Q, Pan F, Yang L. Spontaneous pneumothorax and subpleural bullae in a patient with COVID-19: a 92-day observation. Eur J Cardiothorac Surg. 2020 Oct 1;58(4):858-860. doi: 10.1093/ejcts/ezaa305.
- Wu J, Feng LC, Xian XY, Qiang J, Zhang J, Mao QX, Kong SF, Chen YC, Pan JP. [Novel coronavirus pneumonia (COVID-19) CT distribution and sign features]. Zhonghua Jie He He Hu Xi Za Zhi. 2020 Apr 12;43(4):321-326. doi: 10.3760/cma.j.cn112147-20200217-00106. Chinese.
- Chavez KV, Pimienta-Ibarra AS, Maruquez-Gonzalez H, Flores-Garces JC, Pena-Mirabal ES, Bolanos-Morales FV. Post COVID-19 pneumo-hematocele: clinical presentation and treatment pathway. Gen Thorac Cardiovasc Surg. 2022 Jun;70(6):566-574. doi: 10.1007/s11748-022-01771-0. Epub 2022 Jan 18.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- HGAM02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on COVID-19 Respiratory Infection
-
Aga Khan UniversityCompletedCOVID-19 Respiratory Infection | COVID-19 Pandemic | COVID-19 Lower Respiratory InfectionPakistan
-
KARE BiosciencesBiomedical Advanced Research and Development Authority; BioLink Life Sciences... and other collaboratorsRecruitingCOVID-19 Pneumonia | COVID-19 Respiratory InfectionIndia
-
Tiziana Life Sciences LTDWithdrawnCovid19 | COVID-19 Respiratory Infection | COVID-19 Lower Respiratory Infection
-
Catalysis SLCompletedRespiratory Tract Infections | Covid19 | SARS-CoV2 Infection | COVID-19 Pneumonia | COVID-19 Respiratory Infection | Viral Infection | Infection, CoronavirusKazakhstan
-
Patrick RobinsonRecruitingCovid19 | COVID-19 Pneumonia | COVID-19 Respiratory Infection | COVID-19 Acute BronchitisUnited States
-
Medical University of LodzRecruitingCOVID-19 | COVID-19 Pneumonia | COVID-19 Respiratory InfectionPoland
-
University of Erlangen-Nürnberg Medical SchoolRecruitingCOVID-19 | Long COVID | COVID-19 Respiratory InfectionGermany
-
Texas Tech University Health Sciences Center, El...RecruitingPneumonia, Viral | COVID-19 Pneumonia | COVID-19 Respiratory InfectionUnited States
-
Administracion Nacional de Laboratorios e Institutos...RecruitingCovid19 | COVID-19 Pneumonia | COVID-19 Respiratory InfectionArgentina
-
Fondazione Policlinico Universitario Agostino Gemelli...CompletedCovid19 | COVID-19 Pneumonia | COVID-19 Respiratory InfectionItaly
Clinical Trials on Pulmonary resection
-
Cancer Institute and Hospital, Chinese Academy...Sun Yat-sen University; Fudan University; Chinese PLA General Hospital; Beijing...Unknown
-
University of GlasgowGolden Jubilee National HospitalUnknownLung Cancer | Ventricular Failure, RightUnited Kingdom
-
Samsung Medical CenterActive, not recruitingStage IA Non-small Cell Lung CancerKorea, Republic of
-
Hôpital CochinCompletedCOPD | Malignant Neoplasm of ThoraxFrance
-
Cancer Institute and Hospital, Chinese Academy...Unknown
-
AHEPA University HospitalCompletedMortality | Patient Outcome Assessment | Morbidity
-
Oslo University HospitalUniversity of Oslo; Helse Stavanger HF; Haukeland University Hospital; St. Olavs... and other collaboratorsRecruitingColorectal Cancer | Liver Metastases | Liver Metastasis Colon Cancer | Colorectal Neoplasms MalignantNorway
-
Meshalkin Research Institute of Pathology of CirculationRecruitingAtrial Fibrillation | Pulmonary HypertensionRussian Federation
-
Boris DzudovicMilitary Medical Academy, Belgrade, Serbia; Galen ResearchEnrolling by invitationChronic Thromboembolic Pulmonary HypertensionSerbia
-
Faculty of Medicine, SousseCompletedChronic Obstructive Pulmonary DiseaseTunisia