Comparison of Sine Waveform High Frequency Chest Wall Oscillation Using Different Settings in Cystic Fibrosis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 17
- 试验地点
- 1
- 主要终点
- Sputum Wet and Dry Weight
研究概览
简要总结
Our primary hypothesis is that airway clearance therapy with sine waveform HFCWO using higher inflation pressures combined with both low and high oscillator frequencies will result in greater sputum production compared to sine waveform HFCWO with lower inflation pressures and mid-frequency oscillations.
详细描述
Patients with cystic fibrosis (CF) perform daily airway clearance therapy to facilitate removal of secretions from their airways. Many different techniques are available to achieve this and there is currently no consensus as to which form of therapy is most effective. High frequency chest wall oscillation (HFCWO) is used by CF patients throughout the United States and abroad. To perform this therapy, the patient wears a vest which fits over the entire torso and is connected to an air compressor. The compressor generates oscillating air pulses that are transmitted to the lungs, thereby mobilizing secretions. The most commonly used device is The Vest™ Airway Clearance System, (Hill-Rom Inc, St Paul, MN). Adjustment of the inflation pressure and frequency of oscillations affects the volume of displaced air and flow of air measured at the mouth of the patient. Previous studies indicate this form of therapy is as effective as more traditional and cumbersome forms of therapy. However, it is unclear which inflation pressures and oscillator frequencies provide optimal airway clearance. Some studies of sine waveform HFCWO reported the largest volume of air displacement and highest air flow measured at the mouth when using a combination of high inflation pressures with either low (7 - 10 Hz) or high frequencies (18 - 20 Hz), but most CF centers in the United States use HFCWO with lower pressures combined with mid-range frequencies (10 - 14 Hz). Furthermore, there are no previous studies assessing the affect of sine waveform HFCWO settings on sputum production. As a result, there is no consensus on which pressure and frequency settings are most efficacious for CF patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- •Diagnosis of CF established by sweat chloride > 60 mmol/L.
- •Age older than 18 years.
- •History of chronic daily sputum production.
- •Currently on a home therapeutic regimen that includes some form of airway clearance performed with a HFCWO device at least once daily that also includes concomitant use of an inhaled mucolytic and inhaled bronchodilator.
- •FVC and FEV1 > 40%-predicted, and with stable lung function (no greater than a 10% variation in lung function parameters over the preceding 3 months).
- •Evaluated at the University of Minnesota CF Center 3 or more times in the preceding 12 months.
排除标准
- •Hospitalization for CF pulmonary complications in the 2 months preceding enrollment.
- •Hemoptysis > 60 cc in a single episode in the 4 weeks preceding enrollment.
- •Chest pain requiring use of narcotic for pain control.
- •Current participation in another clinical trial.
- •Use of intravenous antibiotics for CF respiratory complications in the 2 months preceding enrollment.
- •No prior experience using HFCWO devices for airway clearance
研究组 & 干预措施
HFCWC with higher pressure/variable frequency settings
Half patients randomly assigned to perform HFCWC therapy first with a higher pressure/variable frequency protocol. This entailed performing a 30 minute session with pressure of 10 and 5 minutes each at frequencies of 8,9, and 10 Hz followed by pressure of 6 and 5 minutes each at frequencies of 18, 19, and 20 Hz. This group subsequently crossed-over to the lower-pressure/mid-frequency HFCWC protocol after a washout period of 2 days. This entailed performing a HFCWC session using a pressure of 5 and frequency of 12 Hz for the entire 30 minute session. The other half of subjects were randomly assigned to perform the lower-pressure/mid-frequency protocol first followed by the higher pressure/mixed-frequency after the 2 day washout period
干预措施: HFCWC with higher pressure/variable-frequency settings (Device)
HFCWC with higher pressure/variable frequency settings
Half patients randomly assigned to perform HFCWC therapy first with a higher pressure/variable frequency protocol. This entailed performing a 30 minute session with pressure of 10 and 5 minutes each at frequencies of 8,9, and 10 Hz followed by pressure of 6 and 5 minutes each at frequencies of 18, 19, and 20 Hz. This group subsequently crossed-over to the lower-pressure/mid-frequency HFCWC protocol after a washout period of 2 days. This entailed performing a HFCWC session using a pressure of 5 and frequency of 12 Hz for the entire 30 minute session. The other half of subjects were randomly assigned to perform the lower-pressure/mid-frequency protocol first followed by the higher pressure/mixed-frequency after the 2 day washout period
干预措施: HFCWC with lower pressure/mid-frequency settings (Device)
HFCWC with lower pressure/mid-frequency settings
lower-pressure/mid-frequency protocol first followed by the higher pressure/mixed-frequency
干预措施: HFCWC with higher pressure/variable-frequency settings (Device)
HFCWC with lower pressure/mid-frequency settings
lower-pressure/mid-frequency protocol first followed by the higher pressure/mixed-frequency
干预措施: HFCWC with lower pressure/mid-frequency settings (Device)
结局指标
主要结局
Sputum Wet and Dry Weight
时间窗: Produced during each airway clearance therapy session on days 1 and 4
All sputum expectorated during all HFCWC sessions was collected in a pre-weighed specimen container and immediately sealed. Half the subjects used higher pressure/mixed frequency on day 1 followed by lower pressure/mid-frequency on day 4. Half the patients performed lower pressure/mid-frequency on day 1 followed by higher pressure/mixed frequency on day 4. All specimens were immediately centrifuged at 21,150 g for 15 min at 4°C, and the supernatant was completely removed to eliminate saliva. The sputum "wet weight" was calculated after re-weighing the container with the sputum pellet. The container was then left open in an oven with the temperature set at 65°C for a minimum of 3 days to allow for complete desiccation. The sputum "dry weight" was calculated after re-weighing the container.
次要结局
- Pre vs. Post Therapy Spirometry(Prior to and following each airway clearance therapy session on days 1 and 4)
- Rheology and in Vitro Cough Transportability of Sputum Produced Immediately Following Airway Clearance Therapy Session(Sputum produced during the 15 minutes immediately following airway clearance therapy sessions on day 1 and day 4)
- Patients' Perceived Comfort Using the Different Settings for the Vest Device(Immediately following each airway clearance therapy on day 1 and day 4)