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临床试验/NCT02758106
NCT02758106已完成不适用

The Instantaneous Effects of High-Frequency Chest Wall Oscillation on Patients With Acute Pneumonic Respiratory Failure Receiving Mechanical Ventilation

Chung Shan Medical University0 个研究点目标入组 73 人开始时间: 2014年2月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
73
主要终点
peak airway pressure

研究概览

简要总结

BACKGROUND: Endotracheal intubation and prolonged immobilization of patients receiving mechanical ventilation may reduce expectoration function. High frequency chest wall oscillation (HFCWO) may ameliorate airway secretion movement; however, the vigorous oscillation may influence ventilator settings and change instantaneous cardiopulmonary responses. The aim of this study was to investigate these issues. METHODS: Seventy-three patients aged >20 years who were intubated with mechanical ventilation for pneumonic respiratory failure were recruited and randomly classified into two groups (HFCWO group, n=36; and control group who received conventional chest physical therapy (CCPT), n=37). HFCWO was applied with a fixed protocol, while CCPT was conducted using standard protocols. Both groups received sputum suction after the procedure. Changes in ventilator settings and the subjects' responses were measured at pre-set intervals and compared within groups and between groups.

详细描述

Pneumonia may increase bronchial secretion and decrease mucociliary function, thereby causing lung atelectasis. Patients with acute pneumonic respiratory failure receiving mechanical ventilation may therefore have a large amount of pulmonary secretions, thereby worsening bronchial hygiene, oxyhemoglobin saturation and ventilation-perfusion match. Cough function is paramount for expectoration; however, coughing is not practical for patients with endotracheal intubation and sedation. High frequency chest wall oscillation (HFCWO) may dislodge airway secretions as efficiently as conventional chest physical therapy (CCPT). However, pneumonia is not currently an indication for chest physical therapy.

HFCWO compresses and relaxes the chest wall to generate an oscillated volume from the lungs, mimicking a "mini-cough" and producing shear stress at the air-mucus interface which changes the sputum rheology, thereby improving ventilation distribution, gas mixing, and forced expired volume in one second. Most studies that have reported no significant effects have focused on mortality, hospital stay, lung function or BODE (a multidimensional 10-point scale of body mass index, severity of airflow obstruction, dyspnea rated with the modified Medical Research Council, and exercise capacity evaluated with the Six-Minute Walk Distance) score. However, these outcome measurements are not associated with the immediate effects of chest physical therapy and may be affected by other factors such as disease severity.

Using the amount of sputum as the outcome measurement of HFCWO is not strongly recommended. However, immediate cardiopulmonary changes in HFCWO have not been studied in patients receiving mechanical ventilation, although this measurement is more explicit than lung function and BODE score, as they are impractical in these patients. Changes in ventilator settings caused by HFCWO are a concern when the patients receive both treatments simultaneously. The aim of this study was to investigate the effect of HFCWO on pneumonic subjects with acute respiratory failure receiving mechanical ventilation by evaluating immediate cardiopulmonary changes and changes in the initial ventilator settings.

Methods

The investigators conducted this comparative prospective randomized controlled single-blinded study at a university hospital. Adult subjects with pneumonia complicated with acute respiratory failure requiring endotracheal intubation and mechanical ventilation were consecutively recruited from a medical intensive care unit (ICU) (20-bed capacity). Pneumonia was defined as the presence of new or progressive pulmonary infiltrates and two of the following: body temperature > 38.3C or < 36C; white blood cell count > 12,000/mL or < 4,000/mL; purulent tracheal secretions without other signs of infection requiring antimicrobial treatment. Acute respiratory failure was defined as a sudden decrease in PaO2 < 60 mm Hg (or arterial oxyhemoglobin saturation < 90%) with or without PaCO2 > 45 mm Hg.17-19 All of the patients had sufficient sputum production to require the physician to order airway secretion clearance. Disease severity was assessed by Acute Physiology and Chronic Health Evaluation (APACHE) II score. Adverse events were evaluated by the investigators and reported to the institutional review board. The exclusion criteria were pregnancy, pneumothorax, manifest hemoptysis, unstable hemodynamics, increased intracranial pressure, and those undergoing major cardiac, thoracic or abdominal surgery.

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
Single (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •acute pneumonic respiratory failure and received endotracheal intubation and mechanical ventilation,
  • •having sufficient sputum production to require the physician to order airway secretion clearance

排除标准

  • •pregnancy
  • •pneumothorax
  • •manifest hemoptysis
  • •unstable hemodynamics
  • •increased intracranial pressure
  • •those undergoing major cardiac, thoracic or abdominal surgery

研究组 & 干预措施

HFCW oscillation

Active Comparator

HFCWO was performed using a Vest Airway Clearance System Model 105 (Hill-Rom, St. Paul, Minnesota). HFCWO was applied to each subject at a frequency of 10-12 Hz and a pulse pressure setting of 1-2 selected for 15 minutes. The patients receiving HFCWO were placed in a semi-upright sitting position. Following HFCWO, suction was performed immediately via an endotracheal tube.

Changes to the initial ventilator settings during HFCWO were recorded before and at 5, 10 and 15 minutes. The variables included peak airway pressure, positive-end expiratory pressure, respiratory rate, fraction of inspired oxygen, inspiratory time, and sensitivity settings. Following HFCWO, suction was performed immediately via an endotracheal tube.

干预措施: Vest Airway Clearance System Model 105 (Device)

placebo intervention

Placebo Comparator

the patients undergoing CCPT received cup-hand percussion with the hands positioned 3 inches from the chest, striking the chest with a waving movement while they were placed in right and left decubitus positions for 5-10 minutes each. Following CCPT, suction was performed immediately via an endotracheal tube.

干预措施: placebo intervention (Device)

结局指标

主要结局

peak airway pressure

时间窗: 15 minutes

mm Hg

mean airway pressure

时间窗: 15 minutes

mm Hg

minute ventilation

时间窗: 15 minutes

liters per minute

respiratory rate

时间窗: 15 minutes

breaths per minute

rapid shallow breathing index

时间窗: 15 minutes

breaths per minute/liter

tidal volume

时间窗: 15 minutes

miniliters

SpO2

时间窗: 15 minutes

次要结局

  • respiratory rate(15 minutes)
  • airway pressure setting(15 minutes)
  • inspiratory time(15 minutes)
  • blood pressures(15 minutes)
  • FiO2= inspired oxygen fraction(15 minutes)
  • heart rate(15 minutes)

研究者

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

Ming-Lung Chuang

Associate Professor of Internal Medicine

Chung Shan Medical University

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