Effect of combination of melatonin with non pharmacological strategies on delirium prevention in ICU- a randomised controlled trial
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- occurrence of delirium in ICU patients
研究概览
简要总结
Delirium in critically ill patients is a significant problem encountered in the ICU. It can be attributed to various causes including the hostile ICU environment with continuous monitor sounds, alarms and lighting; the lack of continuous presence of family; or the underlying disease condition itself. Preventing the development of delirium in ICU patients may not only reduce the length of ICU stay, but may in turn reduce the length of hospital stay and thus improve outcomes.
Association between sleep and delirium in the ICU has been established by some studies. Promoting sleep through non- pharmacologic means may reduce the incidence of delirium. Melatonin which is a regulator of circadian rhythm is found to be low in critically ill patients and hence may need supplementation.
Use of some non-pharmacological measures like ear plugs and eye mask have shown promising results in some trials while pharmacological measures have been found useful in some others. While both interventions may have certain limitations individually, but as a part of multicomponent strategy, in combination, they can possibly be more effective. Therefore we wish to conduct a randomised trial to study the effect of such a prophylactic bundle of non pharmacological methods and oral melatonin in promoting sleep and to study its ability to prevent or reduce the occurrence of delirium in ICU patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1 adults admitted to icu expected to stay for more than 24 hours 2 ability of patients to understand and communicate 3 patients should be enrolled within 24 hours of ICU admission.
排除标准
- •invasive ventilation altered sensorium or psychiatric illness or seizure or sleep apnoea hearing or vision impairment pregnancy and breast feeding nil bh mouth hepatic impairment or liver transplant history of substance abuse severe heart failure or hypotension hight blood sugar already on melatonin therapy or drug allergy to melatonin.
结局指标
主要结局
occurrence of delirium in ICU patients
时间窗: CAM ICU will be assessed at 8am 2pm and 8pm everyday for 3 consecutive days in both groups
1 incidence of delirium
时间窗: CAM ICU will be assessed at 8am 2pm and 8pm everyday for 3 consecutive days in both groups
2 duration of delirium
时间窗: CAM ICU will be assessed at 8am 2pm and 8pm everyday for 3 consecutive days in both groups
次要结局
- indirect markers of delirium severity(need for antipsychotic or sedation or physical restraints or participation in physiotherapy sessions or patient removal of IV lines or catheters shall be assessed daily for 3 consecutive days)
- sleep quality assessment by Richards Campbell sleep questionnaire(sleep questionnaire shall be answered everyday in the morning at 8am for 3 consecutive days)
- compliance and comfort of ear plugs and eye mask(ease of use, effectiveness and comfort shall be assessed at 8am for 3 consecutive days)
- length of stay in icu or hospital and impact on outcome(till discharge from icu or hospital)
研究者
Dr. Ankhitha R S
Narayana hrudayalaya Surgical hospital mysore