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The objective of this single-center retrospective observational study is to describe spirometric abnormalities and their impact on 6-minute walk test (6MWT) and the physical component summary (PCS) of the SF-36 quality of life instrument.at least 3 months later discharge hospital.
Background: The COVID-19 pandemic has already affected more than 400 million people worldwide and resulted in at least 6 million deaths. The disease has also resulted in a growing population of individuals, with both physical and mental sequelae. Pulmonary sequelae have been the subject of several studies because the lung is the main target organ of the disease. However, there is still unknown data about the pulmonary manifestations and their spirometric patterns after a critical illness and also its consequences in quality of life.
Purpose: Up to 20% of COVID-19 patients develop severe forms of the disease and require ICU admission. Most of these patients at hospital discharge still have several limitations that impact on quality of life. Some studies have analyzed pulmonary functional alterations after a variable period of time and have found results that vary from the absence of functional alterations to restrictive and diffusion impairment. Few studies have analyzed changes in small airways, and those that have evaluated have found no changes. The objective of this single-center retrospective observational study is to describe spirometric abnormalities and their impact on 6-minute walk test (6MWT) and the physical component summary (PCS) of the SF-36 quality of life instrument.at least 3 months later discharge hospital.
Primary outcome: To describe spirometric patterns associated to severe COVID-19 survivors at least 3 months after hospital discharge.
Secondary outcomes: Correlate the results of the spirometric evaluation with the 6-minute walk test (6MWT) and the physical component summary (PCS) of the SF-36 quality of life instrument.
Methods: An observational retrospective study will be conducted, including all 18 years and older patients with severe COVID-19, confirmed by real-time reverse transcriptase-polymerase chain reaction., admitted to a 35- bed intensive care unit of a tertiary hospital from April 2020 to October 2021. Pediatric, pregnant or breastfeeding women and palliative care patients as well as chronic obstructive pulmonary disease and symptomatic asthmatic patients will be excluded. Population is estimated at 60 patients. Data collecting will be finished in February 2022. Patients routinely are assessed after at least 3 months after hospital discharge in our multidisciplinary follow-up clinic. A trained research team will routinely apply the 6 minute walk test (6MWT), a Pulmonary Function Test (PFT) and Short Form Health Survey 36 (SF-36) physical component summary (PCS) of SF-36
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Respiratory function 3 months after hospital discharge in critically ill COVID-19 patients | All critically ill adult patients admitted to the ICU with confirmed diagnosis of COVID-19 were submitted at least 3 months after hospital discharge to spirometry (FVC, FEV1, FEV1 /;FVC and FEF 25-75%), the 6-minute walk test (6MWT) and evaluation of the physical component summary (PCS) of the SF-36 quality of life instrument. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spirometric evaluation | Diagnostic Test | Evaluation of: forced vital capacity (FVC),, FEV1', FEV 1/FVC, FEF 25-75 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Forced vital capacity (FVC) | Forced vital capacity (FVC) is the volume of air that can forcibly be blown out after full inspiration, Measured in liters. Normal value > 80% of predicted for age, sex, heigth and ethnicity | 3 months after hospital discharge |
| Forced expiratory volume in 1 second (FEV1) | FEV1 is the volume of air that can forcibly be blown out in first 1 second, after full inspiration. Measured in liters. Normal value > 80%. of predicted for age, heigth and ethnicity. | 3 months after hospital discharge |
| FEV1 / FVC Ratio | Represents the proportion of vital capacity that the patients are able to expire in the first second of forced expiration (FEV1) to the full, forced vital capacity (FVC). The result of this ratio is expressed as FEV1%. Normal values are > 75%.of predicted that depend on age, sex, height, and ethnicity | 3 months after hospital discharge |
| Forced mid-expiratory flow (FEF25-75%) | Defined as the mean forced expiratory flow during the middle half of the FVC . Normal value > 65% of predictedf for age, sex, heigth and ethnicity | 3 months after hospital discharge |
| Measure | Description | Time Frame |
|---|---|---|
| Physical Component Summary (PCS) of Short Form- 36 (SF-36) Instrument | PCS is composed of four scales assessing physical function, role limitations caused by physical problems, bodly pain and general health. The result scale ranges from 0 to 100, with 0 being the worst result and 100 the best. | 3 months after hospital discharge |
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Inclusion Criteria
Exclusion criteria
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Patients with confirmed COVID-19 admitted to the ICU requiring non-invasive or invasive respiratory support
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| Name | Affiliation | Role |
|---|---|---|
| JOAQUIM LOBATO, MD | Hospital Sao Domingos | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Sao Domingos | São LuÃs | Maranhão | 65060645 | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32600344 | Background | Huang Y, Tan C, Wu J, Chen M, Wang Z, Luo L, Zhou X, Liu X, Huang X, Yuan S, Chen C, Gao F, Huang J, Shan H, Liu J. Impact of coronavirus disease 2019 on pulmonary function in early convalescence phase. Respir Res. 2020 Jun 29;21(1):163. doi: 10.1186/s12931-020-01429-6. | |
| 31613151 | Background | Graham BL, Steenbruggen I, Miller MR, Barjaktarevic IZ, Cooper BG, Hall GL, Hallstrand TS, Kaminsky DA, McCarthy K, McCormack MC, Oropez CE, Rosenfeld M, Stanojevic S, Swanney MP, Thompson BR. Standardization of Spirometry 2019 Update. An Official American Thoracic Society and European Respiratory Society Technical Statement. Am J Respir Crit Care Med. 2019 Oct 15;200(8):e70-e88. doi: 10.1164/rccm.201908-1590ST. |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| Physical component summary | Diagnostic Test | Evaluation of the physical component summary of SF-36 quality of life |
|
| 6MWT | Diagnostic Test | 6 minute walk test |
|
| 6 Minute Walk Test |
The patient is placed on a flat, rigid area 30 meters long and instructed to walk the longest tolerable distance for 6 minutes. Measured in meters. The result is given as a percentage of the normal predicted value for age, sex, height and weight calculated by the Enright and Sherril equation. |
| 3 months after hospital discharge |
| 31978945 | Result | Zhu N, Zhang D, Wang W, Li X, Yang B, Song J, Zhao X, Huang B, Shi W, Lu R, Niu P, Zhan F, Ma X, Wang D, Xu W, Wu G, Gao GF, Tan W; China Novel Coronavirus Investigating and Research Team. A Novel Coronavirus from Patients with Pneumonia in China, 2019. N Engl J Med. 2020 Feb 20;382(8):727-733. doi: 10.1056/NEJMoa2001017. Epub 2020 Jan 24. |
| 15860716 | Result | Hui DS, Joynt GM, Wong KT, Gomersall CD, Li TS, Antonio G, Ko FW, Chan MC, Chan DP, Tong MW, Rainer TH, Ahuja AT, Cockram CS, Sung JJ. Impact of severe acute respiratory syndrome (SARS) on pulmonary function, functional capacity and quality of life in a cohort of survivors. Thorax. 2005 May;60(5):401-9. doi: 10.1136/thx.2004.030205. |
| 32554533 | Result | Frija-Masson J, Debray MP, Gilbert M, Lescure FX, Travert F, Borie R, Khalil A, Crestani B, d'Ortho MP, Bancal C. Functional characteristics of patients with SARS-CoV-2 pneumonia at 30 days post-infection. Eur Respir J. 2020 Aug 6;56(2):2001754. doi: 10.1183/13993003.01754-2020. Print 2020 Aug. |
| 32505211 | Result | Li X, Wang C, Kou S, Luo P, Zhao M, Yu K. Lung ventilation function characteristics of survivors from severe COVID-19: a prospective study. Crit Care. 2020 Jun 6;24(1):300. doi: 10.1186/s13054-020-02992-6. No abstract available. |
| 32381497 | Result | Mo X, Jian W, Su Z, Chen M, Peng H, Peng P, Lei C, Chen R, Zhong N, Li S. Abnormal pulmonary function in COVID-19 patients at time of hospital discharge. Eur Respir J. 2020 Jun 18;55(6):2001217. doi: 10.1183/13993003.01217-2020. Print 2020 Jun. |
| 32512021 | Result | You J, Zhang L, Ni-Jia-Ti MY, Zhang J, Hu F, Chen L, Dong Y, Yang K, Zhang B, Zhang S. Anormal pulmonary function and residual CT abnormalities in rehabilitating COVID-19 patients after discharge. J Infect. 2020 Aug;81(2):e150-e152. doi: 10.1016/j.jinf.2020.06.003. Epub 2020 Jun 5. No abstract available. |
| 32838236 | Result | Zhao YM, Shang YM, Song WB, Li QQ, Xie H, Xu QF, Jia JL, Li LM, Mao HL, Zhou XM, Luo H, Gao YF, Xu AG. Follow-up study of the pulmonary function and related physiological characteristics of COVID-19 survivors three months after recovery. EClinicalMedicine. 2020 Aug;25:100463. doi: 10.1016/j.eclinm.2020.100463. Epub 2020 Jul 15. |
| 20337995 | Result | Ngai JC, Ko FW, Ng SS, To KW, Tong M, Hui DS. The long-term impact of severe acute respiratory syndrome on pulmonary function, exercise capacity and health status. Respirology. 2010 Apr;15(3):543-50. doi: 10.1111/j.1440-1843.2010.01720.x. Epub 2010 Mar 19. |
| 34446020 | Result | Lindahl A, Reijula J, Malmberg LP, Aro M, Vasankari T, Makela MJ. Small airway function in Finnish COVID-19 survivors. Respir Res. 2021 Aug 26;22(1):237. doi: 10.1186/s12931-021-01830-9. |
| 34190851 | Result | Polese J, Sant'Ana L, Moulaz IR, Lara IC, Bernardi JM, Lima MD, Turini EAS, Silveira GC, Duarte S, Mill JG. Pulmonary function evaluation after hospital discharge of patients with severe COVID-19. Clinics (Sao Paulo). 2021 Jun 28;76:e2848. doi: 10.6061/clinics/2021/e2848. eCollection 2021. |
| 33262076 | Result | Torres-Castro R, Vasconcello-Castillo L, Alsina-Restoy X, Solis-Navarro L, Burgos F, Puppo H, Vilaro J. Respiratory function in patients post-infection by COVID-19: a systematic review and meta-analysis. Pulmonology. 2021 Jul-Aug;27(4):328-337. doi: 10.1016/j.pulmoe.2020.10.013. Epub 2020 Nov 25. |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |