"Barotrauma in Admitted Covid-19 Cases - A Single Center Retrospective Study"

NCT05216523 | Completed

• 1 other identifier: #2463
• Study Type: observational
• Target: 251
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Barotrauma; COVID-19

Keywords

Barotrauma; COVID-19; positive pressure ventilation; ferritin; steroids

Outcome Measures

Primary Outcomes (1)

• Incidence of Barotrauma in admitted Covid-19 cases

  Incidence of Barotrauma in admitted Covid-19 cases between March 2020 till April 2021

  1-102 days

Secondary Outcomes (3)

• Association of factors with Barotrauma in admitted Covid-19 cases

  1-102 days

• Mortality with cases versus controls

  1-102 days

• Ventilation days of cases versus controls

  1-65 days

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• All admitted adult patients with covid PCR positive result
• Those who developed barotrauma were labeled as "Cases" and those without barotrauma were "Controls".

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sultan Qaboos University: lead

Study Sites (1)

Sultan Qaboos University Hospital

Muscat, 123, Oman

Location

Related Publications (4)

• 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.

  PMID: 32348588 BACKGROUND

• 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.

  PMID: 33560192 BACKGROUND

• 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.

  PMID: 33450202 BACKGROUND

• 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.

  PMID: 33310838 BACKGROUND

MeSH Terms

Conditions

Barotrauma; COVID-19

Condition Hierarchy (Ancestors)

Wounds and Injuries; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Jyoti Burad

  Sultan Qaboos University Hospital

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Senior specialist

Study Record Dates

• First Submitted: January 28, 2022
• First Posted: January 31, 2022
• Study Start: June 24, 2021
• Primary Completion: November 30, 2021
• Study Completion: November 30, 2021
• Last Updated: July 10, 2024

Record last verified: 2024-07

Locations

OM (1)