A Randomized Controlled Trial of Non-invasive Ventilation With Adaptive Support Ventilation Versus Neurally Adjusted Ventilator Assist in Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 试验地点
- 2
- 主要终点
- Rate of NIV failure
研究概览
简要总结
Non invasive ventilation is the standard of care in managing patients with exacerbation of chronic obstructive pulmonary disease. However no optimal mode of NIV delivery is established; failure rates remain high, attributed to asynchrony and leak associated with NIV. Neurally adjust ventilator assist is a new mode that may improve patient ventilator interactions, improve synchrony and contribute to improved outcomes. Likewise ASV is a mode principled on the closed loop system and is associated with reduction of work associated with breathing and improved outcomes. In this randomised, non-blinded trial, we study these two modes of NIV delivery in patients of AECOPD with hypothesis being that better synchrony with NAVA may translate to better clinical outcomes.
详细描述
Study hypothesis We hypothesize that NIV-NAVA would be superior to ASV in reducing the NIV failure rates in patients with AECOPD. In this study, we plan to compare the ASV with NAVA during NIV in patients with AECOPD.
Methods All consecutive patients meeting the inclusion criteria will be screened and assessed for eligibility. Informed consent will be sought and those enrolled would be randomized to to receive NIV using either the ASV or the NIV-NAVA mode. The NIV will be delivered using a oro-nasal mask with supplemental oxygen as needed.
Delivery of NAVA NAVA will be delivered using Servo-i ventilator (Maquet, Getinge Group, Sweden) with software to compensate for air leaks.
NAVA initiation would involve calibration of the Edi module, placement of the nava catheter nasogastrically, verification of position and selecting appropriate nava level on the basis of required pressure support. In case a favourable response is not obtained, NAVA level will beincreased by 0.2 cm/µV until favourable response is seen (tidal volume 6-8mL/kg, respiratory rate < 25/min)
Delivery of ASV ASV will be delivered using a Galileo GOLD ventilator (Hamilton Medical, AG, Switzerland).The patients will be ventilated with an initial setting of 100%-minute volume and will be titrated in increments of 10% as per clinical parameters (respiratory rate, tidal volume).
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Consecutive subjects with AECOPD will be eligible for inclusion in the study if they meet all the following: (a) an acute (<7 days) sustained worsening of any of the patient's respiratory symptoms (cough, sputum quantity or character, dyspnea) beyond the normal day-to-day variation; (b) arterial blood gas analysis showing a PaCO2 >45 mm Hg with either pH between 7.10 and 7.35 or respiratory rate (fR) >30 breaths/minute; and, (c) exclusion of other causes of acute breathlessness such as acute heart failure, pulmonary embolism, pneumonia, and pneumothorax.
排除标准
- •Patients with any one of the following criteria will be excluded from the current study:
- •Non-COPD acute hyper-capneic respiratory failure
- •Hypotension (systolic blood pressure <90 mmHg)
- •Severe impairment of consciousness (Glasgow coma scale score <8)
- •Inability to clear respiratory secretions
- •Abnormalities that preclude proper fit of the NIV interface (agitated or uncooperative patient, facial trauma or burns, facial surgery, or facial anatomical abnormality
- •Subjects who have an artificial airway like tracheostomy tube or T-tube
- •Contraindications for insertion of naso-/orogastric feeding tube (facial/nasal trauma, recent upper airway surgery, esophageal surgery, esophageal varices, upper gastrointestinal bleeding)
- •Unwillingness to undergo placement of nasogastric catheter
- •Known phrenic nerve lesions
- •Suspected diaphragmatic weakness
- •Patient already on home NIV therapy for chronic respiratory failure
- •Failure to provide informed consent
结局指标
主要结局
Rate of NIV failure
时间窗: From initiation of NIV to either intubation or re-initiation of NIV or successful weaning
NIV failure will be considered in case of • Endotracheal intubation
次要结局
- Physician's ease of use of the mode on visual analogue scale(Assessed every 8 hours until primary outcome)
- 28-day mortality rate(28 days)
- 90-day mortality rate(90 days)
- Time to NIV failure(28 days)
- Time to successful weaning(28 days)
- Average number of manipulations(28 days)
- Patient assessed level of comfort using visual analogue scale(28 days)
- Asynchrony index(28 days)
研究者
Inderpaul singh
Assistant Professor
Post Graduate Institute of Medical Education and Research, Chandigarh