A Prospective, Randomized Controlled Trial Comparing Noninvasive Ventilation (NIV) Versus High-Velocity Nasal Cannula (HVNC) in the Management of Acute Post-Operative Respiratory Failure
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Weaning success
研究概览
简要总结
Postoperative respiratory failure (PORF) remains a critical driver of morbidity, mortality, and incremental care costs in surgical populations. Traditional escalation often involves invasive mechanical ventilation, which is associated with ventilator-associated pneumonia (VAP), prolonged intensive care unit (ICU) stays, and increased resource burden.
详细描述
Noninvasive ventilation (NIV) and high-flow nasal cannula (HFNC) have both been shown to improve oxygen levels effectively and reduce the need for reintubation in various patient groups. However, head-to-head data in patients with obstructive or restrictive pulmonary function (PORF) are scarce.
This protocol employs a robust and scalable design to generate high-quality evidence, empower perioperative stakeholders, and optimize patient-centric respiratory strategies. We hypothesize that NIV will reduce 72-hour reintubation rates compared to HFNC, translating into shorter ICU stays and lower costs.
Methodology & Operational Workflow
- Screening & Consent Identify eligible patients in the post-anesthesia care unit (PACU) or ICU. Obtain informed consent from the patient or legal surrogate.
- Baseline Assessment The baseline assessment includes demographics, comorbidities, and surgical data, as well as baseline arterial blood gases (ABG), vital signs, and comfort scores.
- Randomization & Initiation Allocate via a secure web-based randomization module. Initiate assigned respiratory support within 30 minutes of notification.
- Monitoring & Data Collection The patient is receiving continuous pulse oximetry and respiratory rate monitoring.
ABGs and fraction of inspired oxygen (FIO2) at 1 hour, 6 hours, and 24 hours. Comfort scores every six hours. Record interface-related adverse events.
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
- •Age above 18 years
- •within 48 hours after major surgery
- •PAO2/FIO2 less than 200
- •Signs of respiratory distress and respiratory rate (RR) more than 25 cycles/minute
排除标准
- •Age below 18 years
- •Pregnant ladies
- •Orofacial trauma or burns
- •Active Gastrointestinal bleeding
研究组 & 干预措施
Non-invasive Ventilation group
NIV Arm
- Device: Bi-level positive airway pressure (BiPAP) via oronasal mask.
- Initial settings: inspiratory positive airway pressure (IPAP) 10 cmH₂O, expiratory positive airway pressure (EPAP) 5 cmH₂O, and fraction of inspired oxygen (FiO₂) titrated to oxygen saturation (SpO₂) ≥ 92%.
- Weaning: Decrement IPAP/EPAP by 2 cmH₂O every four hours as tolerated.
干预措施: BIPAP (Device)
High Velocity Nasal Cannula (HVNC) group
HVNC Arm
- Device: Heated, humidified high-flow nasal cannula (HFNC) system.
- Initial flow: 50 L/min, fraction of inspired oxygen (FiO₂) titrated to SpO₂ ≥ 92%.
- Weaning: Reduce flow by 10 L/min every 4 h as tolerated.
干预措施: Vapotherm (Device)
结局指标
主要结局
Weaning success
时间窗: At 48 hours and then daily for 28 days.
The primary outcome will be comparing the weaning success (in days) for both arms of the study group. This will be accessed after 48 hours and on a daily basis until the weaning criteria are met or for 28 days.
次要结局
未报告次要终点
研究者
Ahmad Shaddad
Associate Professor
Assiut University