Respiratory Function 3 Months After Hospital Discharge in Critically Ill COVID-19 Patients

COVID-19 Clinical Trial

Official title:

Respiratory Function 3 Months After Hospital Discharge in Critically Ill COVID-19 Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05249842
• Other study ID #: 53
• Status: Completed
• Start date: April 1, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: August 2022
• Source: Hospital Sao Domingos
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 30, 2022
• Est. primary completion date: March 31, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria

• All 18 years and older patients with severe COVID-19, confirmed by real-time reverse transcriptase-polymerase chain reaction., admitted to a 15- bed intensive care unit of a tertiary hospital from April 2020 to October 2021.

Exclusion criteria

• < 18 years old

• Pregnant

• Breastfeeding

• Chronic pulmonary obstructive disease

• Symptomatic asthma

Related Conditions & MeSH terms

• COVID-19

Intervention

Diagnostic Test:
• Spirometric evaluation
Evaluation of: forced vital capacity (FVC),, FEV1', FEV 1/FVC, FEF 25-75
• Physical component summary
Evaluation of the physical component summary of SF-36 quality of life
• 6MWT
6 minute walk test

Locations

Country	Name	City	State
Brazil	Hospital Sao Domingos	São Luis	Maranhao

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Sao Domingos

Country where clinical trial is conducted

Brazil, 

References & Publications (13)

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). pii: 2001754. doi — View Citation

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. — View Citation

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. — View Citation

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 c — View Citation

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. — View Citation

Lindahl A, Reijula J, Malmberg LP, Aro M, Vasankari T, Mäkelä MJ. Small airway function in Finnish COVID-19 survivors. Respir Res. 2021 Aug 26;22(1):237. doi: 10.1186/s12931-021-01830-9. — View Citation

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). pii: 2001217. doi: 10.1183/13993003.01217-2020. Print 2020 Jun. — View Citation

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 — View Citation

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/cl — View Citation

Torres-Castro R, Vasconcello-Castillo L, Alsina-Restoy X, Solis-Navarro L, Burgos F, Puppo H, Vilaró 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: 10.10 — View Citation

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.20 — View Citation

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 — View Citation

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 — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Secondary	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
Secondary	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