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临床试验/NCT05249842
NCT05249842已完成不适用

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

Hospital Sao Domingos1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2020年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
1
主要终点
Forced expiratory volume in 1 second (FEV1)

研究概览

简要总结

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.

详细描述

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

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Retrospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Forced expiratory volume in 1 second (FEV1)

时间窗: 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%)

时间窗: 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

时间窗: 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)

时间窗: 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

次要结局

  • 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)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

José Raimundo Araujo de Azevedo

ICU Coordinator

Hospital Sao Domingos

研究点 (1)

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