NCT05067881

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
37

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Mar 2020

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2020

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2020

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 20, 2021

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

September 28, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 5, 2021

Completed
Last Updated

October 5, 2021

Status Verified

October 1, 2021

Enrollment Period

Same day

First QC Date

September 28, 2021

Last Update Submit

October 1, 2021

Conditions

Keywords

COVID-19PneumohematoceleGiant bullaePneumatocele

Outcome Measures

Primary Outcomes (1)

  • PHC diagnosis

    Pneumohematoceles on imaging studies

    From date of diagnosis until 4 weeks after diagnosis

Study Arms (1)

Pneumohematocele

Patients with SARS CoV-2 diagnosis and PHC on imaging studies

Procedure: Pulmonary resection

Interventions

Resection of pneumohematocele

Pneumohematocele

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients with a positive chain reaction for SARS CoV-2 who had PHC on imaging studies in two hospitals of Mexico City

You may qualify if:

  • Adults with a positive protein chain reaction for SARS-CoV2,
  • PHC on imaging studies.

You may not qualify if:

  • loss of follow up
  • age out of range.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karla VerĂ³nica ChĂ¡vez Tostado

Mexico City, 14500, Mexico

Location

Related Publications (26)

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    PMID: 3368637BACKGROUND
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    PMID: 19373539BACKGROUND
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    PMID: 3333168BACKGROUND
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    PMID: 32125131BACKGROUND
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    PMID: 32077789BACKGROUND
  • 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.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Karla V Chavez Tostado, MD

    Head of surgery department

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of Surgery department

Study Record Dates

First Submitted

September 28, 2021

First Posted

October 5, 2021

Study Start

March 1, 2020

Primary Completion

March 1, 2020

Study Completion

September 20, 2021

Last Updated

October 5, 2021

Record last verified: 2021-10

Locations