The Role of HFCWO Via The Vest® Airway Clearance System in Addition to NIRT in the Treatment of Patient With Acute Respiratory Failure and Hypersecretion: Monocentric, Parallel Group, Controlled Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 88
- 试验地点
- 2
- 主要终点
- Rate of patients undergoing bronchoscopy
研究概览
简要总结
The study aims to evaluates if the treatment with HFCWO Via The Vest® Airway Clearance System, in addition to standard care in critically ill patients admitted in the Respiratory Intensive Care Unit for acute respiratory failure or acute on chronic respiratory failure and unable to manage secretions, could primarily prevent the need for bronchoscopy, and secondarily shorten duration of non invasive respiratory therapy, shorten length of stay and reduce mortality.
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
- 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
- •Diagnosis of acute respiratory failure (ARF) or acute on chronic respiratory failure (including patients having home oxygen therapy, HFNC, NIV) both hypercapnic ARF (PaCO2 > 45 mmHg; PaO2/FiO2 <300) or hypoxaemic (PaCO2 <45 mmHg; PaO2/FiO2 <300);
- •Informed consent from patient or legal tutor;
- •Accessory respiratory muscles use;
- •Respiratory rate above 25 apm;
- •Use of non invasive respiratory therapy (NIRT) NIV+/-HFNC or HFNC alone since RICU admission
- •Kelly neurological index ≤ 3
- •Excessive airway mucus secretion (clinical evaluation asking the patient to cough) and inability to efficiently remove secretions (evaluated with the Cough Peak Flow (CPF) measurement. A CPF under 270 Lpm is highly suggestive of inadequate cough which prevent the patient from adequately manage and remove airway secretions.
- •Cough score < 3: in the case of inability to perform CPF measurement due to poor patient collaboration, cough adequacy will be evaluated by a respiratory physiotherapy with a semiquantitative score ("Cough score") based on the measurement of sputum volume produced after coughing three times (1 point: less than 2 mL, 2 points: 2-6 mL, 3 points: more than 6 mL).
排除标准
- •Patient unwillingness or incapability to provide informed consent
- •Need for subcontinuous NIV(more than 20 hours per day)
- •Kelly neurological index >3
- •Cardiac arrest
- •Severe haemodynamic instability (more than two amines required);
- •acute coronary syndrome;
- •Psychomotor agitation unresponsive to analgo-sedation (RASS> 1)
- •Contraindications to HFCWO use: acute pneumothorax (even if chest drainage is not required ); severe chest wall deformities (pectus excavatum, pectus carinatum or pectus arcuatum); severe obesity (BMI >40 kg/m2); pregnancy; thoracic or abdominal surgery in the six previous weeks
- •Nasal swab positivity to Sars-CoV-2
- •Need for endotracheal intubation or urgent bronchoscopy for excessive airway mucus
结局指标
主要结局
Rate of patients undergoing bronchoscopy
时间窗: From date of randomization until the date when the patients undergoes bronchoscopy becauase he/she is unable to spontaneously remove secretion assessed as worsening of gas exchange or of radiological appearance, whichever comes first, up to 30 days
Bronchoscopy is required when the patient is unable to spontaneously remove secretions despite physiokinesitherapy (Cough score \< 3 and gas exchange deterioration during NIRT (PaO2/FiO2\<200 or PaO2 \<60 and/or PaCO2 increasement of 20%) and/or radiological worsening (development of lobar/multilobar/pulmonary atelectasis or pre-existing atelectasis worsening)
次要结局
- Number of patients who undergo endotracheal intubation for inability to manage secretions in patients without a "do not resuscitate" (DNR) indication and RICU mortality for DNR patients(From date of randomization until the date when the patient intubated for acute worsening of clinical conditions, assessed during hospital stay, up to 90 days)
- Days of non-invasive respiratory treatment (NIRT) duration(From date of randomization until the date when the patient no more requires NIRT because of improving gas exchange, assessed up to 30 days (days))
- Days of RICU (respiratory intensive care unit) stay(From date of randomization until the date when the patient is clinically stable to be discharged from RICU, assessed up to 30 days (days-weeks))
- Sputum volume(10 days)
- Comfort in using The Vest airway clearance system in patients treated with HFCWO + NIRT(48 hours after HFCWO treatment starting)
- Respiratory function tests 90 days after hospital discharge(90 days after hospital discharge)
- Number of patients who undergo endotracheal intubation and Invasive mechanical ventilation(From date of randomization until the date when the patient intubated for acute worsening of clinical conditions, assessed during hospital stay, up to 90 days)
研究者
Raffaele Scala
Head of Respiratory Intensive Care Unit
Ospedale San Donato