Impact of Noninvasive Ventilation Weaning Protocol on Outcome of Patients With Acute Exacerbation of Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Successful weaning
研究概览
简要总结
Noninvasive ventilation (NIV) has revolutionized the management of patients with acute exacerbation of chronic obstructive pulmonary disease (AECOPD) with hypercapnic respiratory failure (HcRF). NIV use has been shown to reduce the need for endotracheal intubation, hospital and intensive care unit (ICU) length of stay, and mortality.
Multiple studies have been conducted on weaning strategies among patients requiring invasive mechanical ventilation. As a result of these studies, definite criteria and protocols have been laid down for weaning from invasive mechanical ventilation. However, no such data are available for the withdrawal of NIV.
Evidence-based reviews suggest that protocols to manage the weaning and liberation of subjects from Mechanical Ventilation could reduce the time that subjects spend receiving mechanical ventilation. However, no such data about protocolized withdrawal of NIV are available.
详细描述
A study to compare protocolized weaning from non-invasive ventilation using three potential strategies of weaning from NIV
- Stepwise reduction of duration of NIV use,
- Stepwise reduction in pressure support of NIV, and
- Immediate withdrawal of NIV. Among patients with Acute respiratory failure due to acute exacerbation of COPD.
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
- Single (Outcomes Assessor)
盲法说明
Due to the nature of the interventions, participants and clinical staff managing the weaning will not be blinded to group assignment. However, outcome assessors [the physician adjudicating weaning success based on predefined criteria] and data analysts will be blinded to group allocation throughout the outcome assessment and analysis phases
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All COPD patients admitted in the respiratory ICU with acute Hypercapnic Respiratory Failure who will be managed with Noninvasive Ventilation without the need for invasive mechanical ventilation will be eligible for inclusion in the study.
排除标准
- •Age: less than 18 years,
- •End organ failure as cardiac/ Liver/ Renal,
- •Patients on home NIV and
- •Those who required NIV for respiratory failure due to diseases other than COPD were not considered for the study.
研究组 & 干预措施
Gradual PS Decrement
): pressure support will be reduced by 2-4 cm H2O every 6-8 h with vitals and blood gas monitoring till IPAP of <8 cm of H2O and EPAP of <4 cm of H2O is attained, after which NIV will be completely withdrawn
干预措施: Noninvasive ventilation (Device)
Gradual Time Decrement
the duration of NIV will be reduced to 16 h on the day of randomization (day 0), then reduced to 12 h on day 1 (including 6-8 h of overnight use), 6-8 h of overnight use on day 2, and complete withdrawal on day 3.
干预措施: Noninvasive ventilation (Device)
Abrupt Withdrawal
patients will be immediately withdrawn from NIV and monitored on spontaneous breathing.
干预措施: Noninvasive ventilation (Device)
结局指标
主要结局
Successful weaning
时间窗: 48 hours
The primary objective of the study is to compare the rate of successful withdrawal of NIV among the three groups.
次要结局
未报告次要终点
研究者
Waleed Gamal Elddin Khaleel
Assistant professor of chest diseases
Assiut University