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

August 1, 2022 updated by: José Raimundo Araujo de Azevedo, Hospital Sao Domingos
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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

Study Type

Observational

Enrollment (Actual)

60

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Maranhao
      • São Luis, Maranhao, Brazil, 65060645
        • Hospital São Domingos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Forced vital capacity (FVC)
Time Frame: 3 months after hospital discharge
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)
Time Frame: 3 months after hospital discharge
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
Time Frame: 3 months after hospital discharge
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%)
Time Frame: 3 months after hospital discharge
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Physical Component Summary (PCS) of Short Form- 36 (SF-36) Instrument
Time Frame: 3 months after hospital discharge
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
6 Minute Walk Test
Time Frame: 3 months after hospital discharge
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Sao Domingos

Investigators

  • Principal Investigator: JOAQUIM LOBATO, MD, Hospital São Domingos

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2020

Primary Completion (Actual)

March 31, 2022

Study Completion (Actual)

June 30, 2022

Study Registration Dates

First Submitted

February 19, 2022

First Submitted That Met QC Criteria

February 19, 2022

First Posted (Actual)

February 22, 2022

Study Record Updates

Last Update Posted (Actual)

August 3, 2022

Last Update Submitted That Met QC Criteria

August 1, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 53

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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