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

Completed

• Conditions: COVID-19
• Interventions: Diagnostic Test: Spirometric evaluation; Diagnostic Test: Physical component summary; Diagnostic Test: 6MWT

• Registration Number: NCT05249842
• Lead Sponsor: Hospital Sao Domingos

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.

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 Timeline

• Study Start: 2020-04-01
• Study First Submitted: 2022-02-19
• Study First Submitted QC: 2022-02-19
• Study First Posted: 2022-02-22
• Primary Completion: 2022-03-31
• Study Completion: 2022-06-30
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-01
• Last Update Posted: 2022-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

Not provided

Read More

Exclusion Criteria

Not provided

Read More

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Respiratory function 3 months after hospital discharge in critically ill COVID-19 patients	Spirometric evaluation	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.
Respiratory function 3 months after hospital discharge in critically ill COVID-19 patients	Physical component summary	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.
Respiratory function 3 months after hospital discharge in critically ill COVID-19 patients	6MWT	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.

Primary Outcome Measures

Name	Time	Method
Forced expiratory volume in 1 second (FEV1)	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.
Forced mid-expiratory flow (FEF25-75%)	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
FEV1 / FVC Ratio	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
Forced vital capacity (FVC)	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

Secondary Outcome Measures

Name	Time	Method
Physical Component Summary (PCS) of Short Form- 36 (SF-36) Instrument	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.
6 Minute Walk Test	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.

Trial Locations

Locations (1)

Hospital Sao Domingos; 🇧🇷 São Luis, Maranhao, Brazil