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临床试验/NCT01786070
NCT01786070Unknown不适用

Effect of Nebulized Budesonide on Preventing Postextubation Complications in Critically Patients

Isfahan University of Medical Sciences1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2011年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
入组人数
70
试验地点
1
主要终点
post extubation stridor

研究概览

简要总结

The aim of this study is evaluation of the effect of administration nebulized budesonide after extubation. The specific objectives of our study are to determine whether multiple doses of nebulized budesonide are effective to reduce or prevent postextubation edema.

In this double-blind randomized clinical trial study, 70 patients (age between 18 to 65) who are intubated (at least for 48 hours) and now are ready for extubation will be enrolled in the study after obtaining a written informed consent from their parents or guardians.

The investigators divide our patients randomly into two equal groups.

-Patients who are in budesonide group will receive nebulized budesonide (1 mg-every 12 hours; n=35) and patients in placebo group receive placebo (normal saline; n=35) until 48 hours after extubation. If patient have extubation criteria the investigators will extubate him and for 24 hours after, another anesthesiologist who is unaware about kind of medication, will evaluate the patients for severity of stridor. We will record the vital sings and grade of stridor every 6 hour. Respiratory rate (RR), heart rate (HR), blood pressure (BP) and oxygen saturation (SPO2) were recorded for each patient immediately before aerosol administration (time 0) and at 30 and 60 min; and 2,4,8,12,24,36 and 48 hrs. After extubation then the presence of stridor (heard with the aid of stethoscope) was recorded within 48 hr of extubation.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Investigator)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients' age 18-55 years old
  • Intubated for more than 48 hours after surgery
  • Met the weaning criteria defined as respiratory rate < 30 breaths / min, negative tidal volume > 5 ml/kg ideal body weight, and shallow index (respiratory rate/tidal volume) < 105 breaths / min/L

排除标准

  • Any history of corticosteroid therapy in previous week
  • Nasal or throat disease / surgery
  • Pulmonary airway disease
  • Gastrointestinal bleeding

研究组 & 干预措施

Budesonide

Active Comparator

Budesonide : 1 mg/4ml every 12 hrs for 48 hrs

干预措施: Budesonide (Drug)

Placebo

Placebo Comparator

Normal saline at an equivalent volume (4 ml every 12 hrs for 48 hrs)

干预措施: placebo (Drug)

结局指标

主要结局

post extubation stridor

时间窗: After extubation until 48 hours

Until 48 hours after extubation we documented if there is stridor in examination

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Saeed Abbasi

Assistant Professor in Anesthesiology

Isfahan University of Medical Sciences

研究点 (1)

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