Effect of Respiratory Exerciser on Pulmonary Functions of COVID-19 Patients, A Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- Peak Expiratory Flow (Follow-up)
研究概览
简要总结
COVID-19 infection is the cause of the current pandemic, responsible for loss of life and disability at a rate unseen before. Among survivors, the infection may cause lasting damage, such as permanent loss of lung function.
This study aims to investigate if pulmonary rehabilitation done via supportive devices may reduce or prevent lung function injury. Patients will be chosen among COVID-19 patients who require hospitalization. Patients then will be divided into two groups, those who had used said devices, and compare them to those who had not used them for any reason. After a month, two groups will be evaluated by respiratory function tests, which are expected to provide the results required for a proper comparison.
Pulmonary rehabilitation provided by the supportive devices is expected to either lessen or eliminate a loss of pulmonary function over time, compared to the group who did not use them.
详细描述
SARS-CoV-2 is a novel coronavirus that is responsible for the current pandemic. Its clinical presentation varies from asymptomatic infection to severe respiratory failure requiring intensive care stay. Loss of respiratory function had been observed in survivors of other coronaviruses in earlier studies. The degree of respiratory function loss and if any intervention may reduce or prevent it remains an issue to be clarified.
The study's goal is to investigate the effects of pulmonary rehabilitation via a supporting device on COVID-19 patients during a follow-up period of one month. The primary method of investigation of pulmonary functions is comparing peak expiratory flow (PEF) at the time of diagnosis and after treatment.
The study hypothesizes that patients who had successfully used a respiratory exerciser or a similar aid device will have better PEF results at the end of the first-month evaluation.
The effect of an incentive spirometer and/or a respiratory exerciser on the pulmonary function results is the main element under investigation in this study. The hospital provides these devices, and in cases, patients demand another device, the patients and their relatives are asked to purchase such equipment.
Pulmonary function tests (PFT) are considered a part of routine evaluation for the COVID-19 patients a month after the treatment. Patients are considered suitable for PFT evaluation if the COVID-19 infectious process is deemed treated, and other contraindications for PFT are not present, such as recent surgery or pneumothorax.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- •Being at least 18 years or older
- •Approval given both written and orally to the study participation
- •COVID-19 positivity proven by reverse transcription-polymerase chain reaction (RT-PCR) testing
- •At least one evaluation/consultation performed by a pulmonary medicine specialist OR admission to pulmonary medicine ward from another department in the hospital
- •First hospital admission has to be via emergency ward, regardless of the concurrent hospital stay.
- •Cooperation at an acceptable degree for pulmonary function testing.
排除标准
- •Any contraindication presence for pulmonary function testing (such as anatomic abnormalities, recent cardiac history, and severe respiratory failure)
- •Former COVID-19 history.
- •Persistent pulmonary or other systemic pathology (which prevents hospital discharge)
- •Refusal to participate in the monthly evaluation.
- •Persistent COVID-19 RT-PCR presence (which prevents PFT testing)
- •Known severe limitation in former PFT testing (FEV1 being lower than 30%)
结局指标
主要结局
Peak Expiratory Flow (Follow-up)
时间窗: Testing for PEF results were performed at the follow-up evaluation, which was done 1 month post-baseline.
The Peak Expiratory Flow (PEF) results were obtained at the follow-up evaluation. These results were then compared with the initial baseline measurement of PEF performed at the hospital discharge.
Change in Peak Expiratory Flow (Absolute Value)
时间窗: The first PEF testing will be performed seven days after initial diagnosis. The second testing will be performed one month after the hospital discharge, among those who are considered suitable for testing.
Two PEF results will be compared in the study. The first PEF testing will be performed by a handheld device and the second measurement will be performed either by an office spirometer or a handheld device. The priority will be given to the office spirometer for testing preference.
Change in Peak Expiratory Flow (Percentage)
时间窗: The first PEF testing will be performed seven days after initial diagnosis. The second testing will be performed one month after the hospital discharge, among those who are considered suitable for testing.
Two PEF results will be compared in the study. The first PEF testing will be performed by a handheld device and the second measurement will be performed either by an office spirometer or a handheld device. The priority will be given to the office spirometer for testing preference.
次要结局
- Forced Expiratory Volume (FEV1)(Forced Expiratory Volume (FEV1) was evaluated at the follow-up evaluation, which was performed one-month post-baseline.)
- Mortality(Mortality evaluation will include the time period of one month after hospital discharge. The total evaluation duration will also include the hospitalization period (which is considered an average of 7 days))
- Forced Vital Capacity (FVC)(Forced Vital Capacity was evaluated at the follow-up evaluation, which was performed 1 month post- baseline evaluation.)
- Discharge to Follow-up Duration (Days)(The time frame for "Discharge to Follow-up Duration" consisted of up to two months post-baseline evaluation. When a patient had arrived for the first follow-up evaluation, the time difference between baseline evaluation and this re-evaluation was noted.)
研究者
Kerem Ensarioğlu
Medical Doctor
Diskapi Yildirim Beyazit Education and Research Hospital