Randomized, This Study Aims To Investigate the Effect of High Frequency Chest Wall Oscillation in Hospitalized Covid-19 Patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Netrophil to lymphocyte ratio
研究概览
简要总结
INFLUENCE OF HIGH FREQUENCY CHEST WALL OSCILLATION IN HOSPITALIZED PATIENTS WITH COVID-19
The purpose of this Interventional study is to investigate the effect of high frequency chest wall oscillation in hospitalized COVID-19 patients on:
- Inflammatory markers: Netrophil to lymphocyte ratio and CRP
- Hemodynamic parameters (Arterial Blood Gases, Heart Rate variability, Respiratory Rate, O2 Saturation).
- Dyspnea, time needed for oxygen weaning, Mortality Rate and Hospital stay period.
Hypotheses :
This Interventional study will test the following Null hypothesis:
- HFCWO will not have an effect in hospitalized COVID-19 patients regarding Arterial Blood Gases, CRP, Dyspnea, Heart Rate variability, Respiratory Rate, O2 Saturation, time needed for Oxygen Weaning, Mortality Rate and Hospital Stay Period.Research Question:
- Is there a significant effect of high frequency chest wall oscillation (HFCWO) in Hospitalized COVID-19 Patients?
详细描述
Novel coronavirus disease 2019 (COVID-19) infections, declared by the World Health Organization (WHO) as a pandemic, had unprecedented global effects on people's daily activities and way of life.
High-frequency chest wall oscillation (HFCWO) have been shown to be effective at loosening and removing airway mucus in hospitalized people. Mucus weight was greater after HFCWO than after traditional airway clearance interventions involving postural drainage and manual percussion and vibration techniques.
Earlier diagnosis of COVID-19 may be facilitated by heart rate (HR) and heart rate variability (HRV) monitoring. HR and HRV parameters could not only help to detect COVID-19 in a timely manner but could also help to identify patients at risk for cardiovascular/pulmonary complications. Additionally, HRV and HR parameters may help to assess the course of the disease.
The World Health Organization indicates that a resting value of RR > 30 breaths/min is a critical sign for the diagnosis of severe pneumonia in adults, while the cut-off value for children varies according to age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 55 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Sixty hospitalized covid-19 patients from both genders their ages will be ranged from 55 - 65 years old.
- •Desaturated covid-19 patients with lung fibrosis are diagnosed by the physician and confirmed by chest CT
- •Duration of illness ranged from 1 week to 2weeks.
- •All patients have resting oxygen saturation (SpO2) from 80 - 92 %
- •O2 therapy is delivered via Nasal cannula or face mask.
- •All patients will approve and sign a consent form before starting the program which will include the purpose, natures and potential risks of the study which will be explained to all patients (Appendix I).
排除标准
- •Hemodynamically unstable patient
- •Patient with pneumothorax (if chest tube is present)
- •Asthmatic patient
- •Patient with chest deformities
- •Patient with pleural effusion
- •Patient with diaphragmatic hernia
- •Patient with cardiac and thoracic surgery
- •Mechanically Ventilated and intubated patients.
- •Metabolic or cardiovascular diseases.
- •Patients have (SpO2) less than 80 %.
- •Patient with severe lung fibrosis.
研究组 & 干预措施
The control group (I)
The control group (I): The participants will follow the traditional pulmonary rehabilitation program including (active cycle of breathing technique, breathing control, deep breathing exercises, huffing). The session duration will be between 30 min twice/day for 15 days as guided by subject fatigue and comfort. (According to Borg scale of dyspnea for monitoring).
The study group (II)
The study group (II): The participants will receive active cycle of breathing technique, breathing control, deep breathing exercises (15 min) in addition to (HFCWO); the patient position will be in a semi-recline position, with wrapped vest around the chest. The (HFCWO) protocol included 3-5 cycles, with a pressure range of +10 to +40 IP cmH2O and will be adjusted according to the patient age, number of secretions, tolerance of patients, and chest auscultation every session. The numbers of total sets will be 3-5 with a duration of 15 min, daily, for two sessions / day , time range according to the ability of the patient. (Çelik et al., 2021).
干预措施: HIGH FREQUENCY CHEST WALL OSCILLATION (Device)
结局指标
主要结局
Netrophil to lymphocyte ratio
时间窗: 2 weeks
The neutrophil-to-lymphocyte ratio (NLR) is an inflammatory marker derived from combining the absolute blood neutrophil and lymphocyte counts, two routinely performed parameters in clinical settings. Recently, studies have reported that NLR levels were higher in more severe patients and were suggested to confer a prognostic value in COVID-19 patients (Lagunas et al.,2020).
Arterial blood gasses (ABG)
时间窗: 2 weeks
Arterial blood gas analysis is a common investigation in emergency departments and intensive care units for monitoring patients with acute respiratory failure. ABG also has some applications in general practice, such as assessing the need for domiciliary oxygen therapy in patients with chronic obstructive pulmonary disease. An arterial blood gas result can help in the assessment of a patient's gas exchange, ventilator control and acid-base balance. (Verma et al., 2010)
CRP
时间窗: 2 weeks
C-reactive protein) CRP) was an independent risk factor for severe COVID-19. The optimal working point was 38.55 mg/L. This is consistent with previous research showing that hypoalbuminemia, lymphopenia, and CRP more than equal to 40 mg/L were the predictive factors for pneumonia progression to respiratory failure (Ko et al., 2016). Besides, higher CRP has been linked to unfavorable aspects of COVID-19 diseases, such as cardiac injury, and ARDS development, and death. (Terpos et al., 2020).
heart rate variability
时间窗: 2 weeks
Earlier diagnosis of COVID-19 may be facilitated by heart rate (HR) and heart rate variability (HRV) monitoring. HR and HRV parameters could not only help to detect COVID-19 in a timely manner but could also help to identify patients at risk for cardiovascular/pulmonary complications. Additionally, HRV and HR parameters may help to assess the course of the disease. (Buchhorn et al., 2020).
respiratory rate
时间窗: 2 weeks
The World Health Organization indicates that a resting value of RR \> 30 breaths/min is a critical sign for the diagnosis of severe pneumonia in adults, while the cut-off value for children varies according to age (World Health Organization, 2020). Resting RR values also contribute to the prognosis of COVID-19 patients as ICU admission and mortality are associated with significantly higher RR values compared to non-ICU patients and survivors (Huang et al., 2020 \& Zhou et al., 2020).
O2 saturation
时间窗: 2 weeks
Levels of dyspnea appear to vary significantly amongst patients suffering from COVID-19 ranging from 18.6 to 59%. (Guan et al., 2020). More recently, Li et al (2020) systematic review on 1,994 COVID-19 patients showed an overall percentage of patients experiencing dyspnea was 21.9% in addition. Huang et al. found a prevalence of breathlessness as high as 92% amongst COVID- 19 patients hospitalized in intensive care units versus 37% in non-intensive care units. (Huang et al.,2020).
次要结局
- dyspnea questionnaire(2 weeks)
- Hospital Stay(one month)
研究者
Hadeel Ibrahim Elsayed Elhannony
Principal Investigator
Cairo University