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临床试验/NCT00549809
NCT00549809已完成3 期

Comparison Between IMV and SIMV/PS for Ventilatory Support of Children: a Randomized Clinical Trial

UPECLIN HC FM Botucatu Unesp2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2005年10月1日最近更新:
适应症

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
70
试验地点
2
主要终点
duration of mechanical ventilation/weaning and length of stay in PICU

研究概览

简要总结

Objectives: to compare intermittent mandatory ventilation (IMV) with synchronous intermittent mandatory ventilation associated with pressure support (SIMV/PS) related to duration of mechanical ventilation/weaning and length of stay in PICU (LS). Design: randomized clinical trial. Setting: Pediatric intensive care unit at a university-affiliated hospital.

详细描述

Objectives: to compare intermittent mandatory ventilation (IMV) with synchronous intermittent mandatory ventilation associated with pressure support (SIMV/PS) related to duration of mechanical ventilation/weaning and length of stay in PICU (LS). Design: randomized clinical trial. Setting: Pediatric intensive care unit at a university-affiliated hospital. Patients: children between 28 days and 4 years old, admitted between 10/2002 and 06/2004, and receiving mechanical ventilation (MV) for more than 48 hours. Patients were randomly assigned into two groups: IMV (IMVG; n=35) and SIMV/PS (SIMVG; n=35). Children with acute respiratory distress syndrome and tracheostomy were excluded. Ventilation and oxygenation data were recorded at admission and beginning of weaning. Results: Groups were not statistically different for age, gender, MV indications, PRISM score, COMFORT scale, sedatives, and ventilation and oxygenation parameters. Median of MV duration was 5 days for both groups (p>0.05). Also, there were no statistical differences for duration of weaning [IMVG: 1 day (1 - 6) vs. SIMVG: 1 day (1 - 6); p>0.05] and LS [IMVG: 8 days (2 - 22) vs. SIMVG: 6 days (3 - 20); p>0.05]. Conclusion: There was no statistically significant difference between IMV and SIMV/PS in these children related to MV and weaning duration, and PICU length of stay.

研究设计

研究类型
Interventional
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
28 Days 至 4 Years(Child)
性别
All
接受健康志愿者

入选标准

  • Children aged between 28 days and four years, who were consecutively admitted to the PICU and required MV for more than 48h were included.

排除标准

  • Children who had chronic respiratory failure, tracheostomy, those transferred from the hospital, or died were excluded as were patients with acute respiratory distress syndrome (ARDS).

结局指标

主要结局

duration of mechanical ventilation/weaning and length of stay in PICU

时间窗: 2 years

次要结局

未报告次要终点

研究者

发起方
UPECLIN HC FM Botucatu Unesp
申办方类型
Other

研究点 (2)

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