Mechanical Insufflation-Exsufflation Compared With CPAP in Patients Admitted to an Intermediate Care Unit With Pneumonia: a Randomised Controlled Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 主要终点
- Need of mechanical ventilation
研究概览
简要总结
Pneumonia, an infection in the lower airways, is a common cause of hospital contacts and a leading cause of death from infections worldwide. Pneumonia is treated with antibiotics, and while waiting for the effect thereof patients may need supportive treatment to help their lungs work optimally.
When patients suffering from pneumonia have problems breathing, Continuous Positive Airway Pressure (CPAP) is widely used. CPAP works by forcing air down the patient's airway. In patients with pneumonia, though CPAP has proven to provide more oxygen to the lungs compared to a standard oxygen mask, it does not have any effect on the outcome.
Mechanical insufflation-exsufflation (MIE), examined in this study, is given through a machine connected to a mask. If provides a positive airway pressure like CPAP, but the inwards pressure is followed immediately by a negative pressure forcing air and mucus up from the lower airways. MIE is currently used successfully in patients suffering from neuromuscular diseases. In these patients, MIE has shown to prevent hospital admission, prolong survival and delay time until need of permanent ventilation. There exists no studies examining the effect of MIE on patients with pneumonia without neuromuscular disorders.
The investigators therefore wish to study patients with severe pneumonia, admitted to an intermediate care unit, and compare patients treated with MIE to patients treated with CPAP.
30 patients will be included and randomly selected to receive either CPAP or MIE. They will be monitored through registration of oxygen need (liters/min) and oxygen levels, respiratory rate and the daily number of suction due to mucus.
Data from each patient regarding their age, sex, other known diseases, the severity of pneumonia, chest X-ray findings, antibiotic treatment up to and during the admission, days admitted, hours admitted to the intermediate care unit, if they are transferred to the intensive care unit and put on a ventilator, 30-days mortality and re-admittance within 30 days of being discharged, will be registered. To enter the study, the patients have to be 18 years old, able to sign a written consent form, have no current chest tube, no recent collapsed lung and no chronic lung disease.
The hypothesizes is that patients receiving MIE will be helped with coughing up mucus in the lower airways, and therefore have less need of oxygen, and that the patients receiving MIE will have a reduced risk of being transferred to the intensive care unit to receive ventilator support and spend shorter time in the intermediate care unit compared with the other group.
详细描述
Background
Mechanical insufflation-exsufflation (MIE) was invented to help mobilize secretion from the lower respiratory tract by simulating a cough [1]. It is widely used in patients who have neuromuscular disease and therefore reduced cough strength, both during hospital admissions, and in patients' homes. Delivered by a Cough Assistor device through a mask, MIE functions by delivering a positive inspiratory pressure followed immediately by a negative expiratory pressure [1].
In patients with neuromuscular disease, MIE prevents hospital admissions, improves survival rates and delay time to tracheostomy [1]. In this patient group, MIE has proven to be safe with few adverse effects, and generally well tolerated [1-3].
In patients with neuromuscular disease and an acute respiratory-tract infection, MIE in combination with non-invasive ventilation (NIV) is superior to NIV alone in removing secretion from the airways in patients with respiratory tract infections [2]. In a study among patients with severe chronic obstructive pulmonary disease (COPD) and difficulties clearing airway secretions after acute respiratory failure, MIE had a significant effect on both oxygenation and dyspnea [3].
Pneumonia is, with a yearly incidence of 5-11 per 1.000 adult population, a leading cause of morbidity worldwide [4]. Around 22-42% of adults with community-acquired pneumonia (CAP) require hospitalization [4]. Globally, pneumonia is the leading cause of death due to infections, and the mortality among hospitalized patients with pneumonia is 5.7-14% [4,5]. Pneumonia is seen with increased incidence in high risk patient groups such as the elderly, smokers, patients with immunodeficiencies and co-morbidities [6]. Early initiation of appropriate antimicrobial therapy is the cornerstone in treatment of pneumonia and has been shown to shorten the course of disease and lessen the risk of complications and mortality [7].
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •Community acquired or nosocomial pneumonia, diagnosed by new infiltrate on an x-ray chest and symptoms and/or objective findings acute lower airway infection
- •18 years or older
- •able to participate in CPAP treatment 10 cm H2O for 5 minutes
- •able to provide written consent
排除标准
- •pneumothorax less than 4 weeks prior to admission
- •current pleural tube
研究组 & 干预措施
Mechanical insufflation-exsufflation arm
MIE will be given as prescribed by physician responsible at the intermediate care unit, typically every 4 hours. MIE will be administered with standard settings of insufflation 20 cm H2O and exsufflation 20 cm H2O, with possible individual changes from 10/-10 H2O up to 40/-40 H2O, and oxygen flow up to 15 l/min. The standard settings will be set to five cycles of 2 seconds insufflation, 3 seconds exsufflation with a three second pause between each cycle. Every treatment session consists of five rounds of five cycles, in all 25 insufflation/exsufflation, with time between each cycle of 30 seconds, meant used for suction.
干预措施: Mechanical insufflation-exsufflation (MIE) (Device)
CPAP arm
CPAP will be given as prescribed by the physician responsible at the intermediate care unit, typically every 4 hours. CPAP will be administered with standard settings of H2O and an oxygen flow of 15L/min.
结局指标
主要结局
Need of mechanical ventilation
时间窗: From admission to discharge/death, in the department responsible for the study, the mean duration of admittance is 7 days. Need of ventilation will be registered by investigator through review of patient chart after discharge from hospital.
For each patient; any need of mechanical ventilation (yes/no) during the entire hospital admission in which the patient is included in the study.
Admission time in intermediate care unit
时间窗: Admission to intermediate care unit (expected approx. 3-5 days)
Time (in hours) of each patient spent admitted to the intermediate care unit
次要结局
- Need of suction(During the entire admission to the intermediate care unit (approx.3-5 days), every episode of suction will be registered by the treating nurse, and total number of episodes will be registered every 24th hours until discharge.)
- Treatment related adverse events(Registered daily on patient chart forms during entire admission to the intermediate care unit, and orally reported to the principal investigator during the admissions (approx. 3-5 days per patient).)
- Respiratory rate(Registered at admission to the intermediate care unit, every 6th hour for the first 24 hours thereafter, and every 24 hours for the duration of admission to the intermediate care unit (approx.3-5 days).)
- Oxygenation therapy(During the entire admission to the intermediate care unit (expected to be approx. 3-5 days) oxygen therapy will be registered every 2 hours for the first 24 hours of admittance, and every 4 hours thereafter until discharge.)
- Oxygenation saturation(During the entire admission to the intermediate care unit (expected to be approx. 3-5 days) oxygen saturation will be registered every 2 hours for the first 24 hours of admittance, and every 4 hours thereafter until discharge.)
研究者
Fredrikke Christie Knudtzen
Specialist Registrar
Odense University Hospital