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Completed

NCT Number: NCT05249842

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

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Sao Domingos

São Luís, Maranhão, 65060645, Brazil

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spirometric evaluation

Diagnostic Test

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

Physical component summary

Diagnostic Test

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

6MWT

Diagnostic Test

6 minute walk test

Primary outcomes

  1. 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

  2. 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. 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

  4. 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

Secondary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Hospital Sao Domingos

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Feb 22, 2022
Registry last updated
Aug 3, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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