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临床试验/CTRI/2025/07/091125
CTRI/2025/07/091125招募中不适用

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

Christian Medical College Vellore Tamilnadu India1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年7月28日最近更新:

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

发起方
Christian Medical College Vellore Tamilnadu India
申办方类型
Private medical college
责任方
Principal Investigator
主要研究者

Devshankar Moosad E I

Christian Medical College, Vellore

研究点 (1)

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