NCT05249842

Brief 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2020

Typical duration for all trials

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

April 1, 2020

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

February 19, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 22, 2022

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2022

Completed
Last Updated

August 3, 2022

Status Verified

August 1, 2022

Enrollment Period

2 years

First QC Date

February 19, 2022

Last Update Submit

August 1, 2022

Conditions

COVID-19

Keywords

COVID-19Critical CareSurvivorsPulmonary function testPhysical component summary

Outcome Measures

Primary Outcomes (4)

  • 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

Secondary Outcomes (2)

  • Physical Component Summary (PCS) of Short Form- 36 (SF-36) Instrument

    3 months after hospital discharge

  • 6 Minute Walk Test

    3 months after hospital discharge

Study Arms (1)

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.

Diagnostic Test: Spirometric evaluationDiagnostic Test: Physical component summaryDiagnostic Test: 6MWT

Interventions

Spirometric evaluationDIAGNOSTIC_TEST

Evaluation of: forced vital capacity (FVC),, FEV1', FEV 1/FVC, FEF 25-75

Respiratory function 3 months after hospital discharge in critically ill COVID-19 patients
Physical component summaryDIAGNOSTIC_TEST

Evaluation of the physical component summary of SF-36 quality of life

Respiratory function 3 months after hospital discharge in critically ill COVID-19 patients
6MWTDIAGNOSTIC_TEST

6 minute walk test

Respiratory function 3 months after hospital discharge in critically ill COVID-19 patients

Eligibility Criteria

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

Patients with confirmed COVID-19 admitted to the ICU requiring non-invasive or invasive respiratory support

You may qualify if:

  • 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.

You may not qualify if:

  • \< 18 years old
  • Pregnant
  • Breastfeeding
  • Chronic pulmonary obstructive disease
  • Symptomatic asthma

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Sao Domingos

São Luís, Maranhão, 65060645, Brazil

Location

Related Publications (13)

  • 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.

    PMID: 32600344BACKGROUND

  • 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.

    PMID: 31613151BACKGROUND

  • 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.

    PMID: 31978945RESULT

  • 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.

    PMID: 15860716RESULT

  • 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.

    PMID: 32554533RESULT

  • 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.

    PMID: 32505211RESULT

  • 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.

    PMID: 32381497RESULT

  • 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.

    PMID: 32512021RESULT

  • 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.

    PMID: 32838236RESULT

  • 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.

    PMID: 20337995RESULT

  • 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.

    PMID: 34446020RESULT

  • 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.

    PMID: 34190851RESULT

  • 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.

    PMID: 33262076RESULT

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

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

Study Officials

  • JOAQUIM LOBATO, MD

    Hospital Sao Domingos

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
ICU Coordinator

Study Record Dates

First Submitted

February 19, 2022

First Posted

February 22, 2022

Study Start

April 1, 2020

Primary Completion

March 31, 2022

Study Completion

June 30, 2022

Last Updated

August 3, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)