Comparison of Adaptive Support Ventilation and Pressure Support Ventilation for Weaning and Extubation Outcomes in Critically Ill Patients in an Indian ICU: A Prospective Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Incidence of successful weaning
研究概览
简要总结
Study Title
Comparison of Adaptive Support Ventilation and Pressure Support Ventilation for Weaning and Extubation Outcomes in Critically Ill Patients in an Indian ICU – A Prospective Randomized Study
Study Summary
This prospective randomized study compares the effectiveness of Adaptive Support Ventilation ASV and Pressure Support Ventilation PSV in weaning critically ill patients from mechanical ventilation. The study population includes surgical and trauma patients with medical comorbidities. Previous studies have shown different outcomes between medical and surgical ICU patients under similar protocols.
Inclusion Criteria
Age above 18 years
Mechanically ventilated for 24 hours or more
APACHE II score between 5 and 30
Exclusion Criteria
Severe neurological or cardiac conditions
Pregnant women
Patients will be enrolled once their acute illness has resolved and the clinical team decides to start weaning. Consent will be obtained from the next of kin. Randomization will be done using permuted block randomization with concealed allocation through opaque sealed envelopes. Patients will be assigned to either ASV or PSV.
Weaning Criteria
Reversal of initial cause for ventilation
Hemodynamic stability with heart rate less than 120 and respiratory rate less than 35
pH greater than 735, tidal volume more than 5 ml per kg, minute volume less than 10 liters per minute
PEEP less than 5 cm H2O, PaO2 greater than 60 mmHg with FiO2 less than 0.4, and PaO2 to FiO2 ratio greater than 150
A standard ICU extubation protocol will be followed. Patients will be considered for extubation when they meet readiness criteria such as:
Hemodynamic stability with minimal or no vasopressors
Adequate oxygenation with PaO2 to FiO2 ratio above 150 to 200 and SpO2 above 92 percent on 40 percent FiO2 or less
Protective airway reflexes like cough and gag
Adequate mental status and ability to protect airway
Successful completion of a spontaneous breathing trial
All other ICU management including sedation, investigations, and resuscitation will be uniform across both groups. Most extubations will occur between 7 AM and 7 PM due to staff availability and institutional safety protocols. This timing is consistent across both groups and does not introduce bias.
Primary Outcome
Successful weaning defined as a composite of:
No need for reintubation within 48 hours
If NIV is needed, HACOR score less than 5
If HFNC is needed, ROX index greater than 285 at 2 hours
Secondary Outcomes
Total duration of mechanical ventilation
Time to successful extubation
ICU length of stay
ICU mortality
Number of manual ventilator adjustments
Number of ABG analyses required
Rate of ventilator associated pneumonia
This study aims to identify the better ventilatory strategy for improving weaning and extubation outcomes in surgical ICU patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)(—)
- 性别
- All
入选标准
- •Mechanical ventilation for at least 24 hrs Patients with APACHE II score of 5.
排除标准
- •a) Mechanical ventilation for less than 24 hours (including self extubation or death).
- •b) Patients with Coexisting severe Neurological/ Neuromuscular/Quadriplegia/Critical illness neuropathy/ Critical illness Myopathy/ Myasthenia gravis/ Guillain Barre syndrome or cardiac diseases as it may prolong weaning for extra-pulmonary reasons.
- •c) Pregnancy.
结局指标
主要结局
Incidence of successful weaning
时间窗: 48 hrs after extubation
次要结局
- 1. Time to Successful Extubation, Duration from initiation of weaning to successful extubation.(2. Total Duration of Mechanical Ventilation, Time from intubation to final extubation)
研究者
Devshankar Moosad E I
Christian Medical College, Vellore
