The Off Label Use of Glycopyrrolate in the Adults Intensive Care Unit.
试验速览
- 阶段
- 1 期
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Number of suctions per day
研究概览
简要总结
Tracheostomized patients in the ICU can have excessive tracheal secretions due to various causes as hyperactive airway, irritation of the mucus producing cells and inhibition of the ciliary functions. Excessive secretions will necessitate frequent suctions which carries the risk of tracheostomy tube obstruction if not managed properly. Excessive tracheal secretions may prolong the ICU stay, increase the nurses workload and increase patients morbidity and mortality.
This clinical trial hypothesizes that the use of glycopyrrolate may decrease the tracheal secretions and hence avoid such complications.
详细描述
Patients fulfilling the inclusion criteria will be randomly assigned into one of 2 groups:
Group G (Intervention group): Patients will receive Glycopyrrolate 0.2 mg IV every 8 hours.
Group C (Control group): Patients will receive 2 mL Normal saline every 8 hours.
Both injections will be labelled as drug A and drug B in the satellite pharmacy .
Both the attending physician, nurse and data collector will be blinded to the injection given.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients above 18 years old.
- •Patients who are admitted to ICU for more than 72 hours.
- •Patients who have tracheostomy tubes with reported frequent need for suction of the tracheostomy tube secretions more than once every 4 hours.
排除标准
- •Patients who have evidence of lower respiratory tract infections and have positive cultures from the tracheal aspirate.
- •Patients who have known sensitivity to Glycopyrrolate.
- •Patients who have tachycardia (heart rate above 120 Beats/minute) or known to have tachyarrhythmiase.g atrial fibrillation.
- •Patients with mitral stenosis
研究组 & 干预措施
intervention group
receive Glycopyrrolate at dose of 0.2 mg IV every 8 hours daily .
干预措施: Glycopyrrolate 0.2 MG (Drug)
placebo group
receive normal saline 2 ml IV every 8 hours daily .
干预措施: normal saline (Drug)
结局指标
主要结局
Number of suctions per day
时间窗: 6 days
Number of suctions per day
次要结局
- Fluid intake(6 days)
- The duration of ICU days(90 days)
- The duration of mechanical ventilation days(90 days)
- Fio2(6 days)
- Mean airway pressure(6 days)
- Positive end expiatory pressure PEEP(6 days)
- Side effects of Glycopyrrolate(6 days)
- Total leukocyte count(6 days)
研究者
MOHAMMED FAWZI ALI ABOSAMAK
ICU consultant
Tanta University