Effectiveness of Combination of Oral Melatonin with Non-Pharmacological Measures vs Non-Pharmacological measures alone on Quality of Sleep in critically ill Adult patients- Randomised Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- To assess the difference in the quality of sleep in patients receiving oral melatonin 5mg along with non-pharmacological measures versus those receiving non pharmacological measures alone as measured by the mean Richards-Campbell Sleep Questionnaire score
研究概览
简要总结
Sleep disturbances are common in the ICU and are associated with worse outcomes like delirium, anxiety, pain, prolonged weaning, increased length of stay, and mortality. Although several factors like disease-related, procedure-related and environment- related have been associated with sleep disturbances in ICU patients; no recommendation has yet been made on improving sleep and restoring circadian rhythm. Studies have evaluated the effect of non-pharmacological and pharmacological interventions in the ICU and they suggest that certain modifications may improve sleep in critically ill patients. However, these studies have been conducted in specialized ICU settings and in western populations, evaluating only isolated interventions and or multifaceted interventions. Further, it is still being inconclusive whether these proposed benefits can be replicated in a randomized controlled trial or would translate to Indian settings.
The current study will evaluate the impact in the quality of sleep with non-pharmacological measures along with or without pharmacological measures (melatonin) in critically ill patients and if there is any significant improvement in sleep outcomes with both the measures or either of the measures, this can help in framing a protocol for improving the quality of sleep in critically ill adult patients as well as decreasing the incidence of delirium, length of stay, pain, anxiety, weaning difficulties and mortality.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult Patients who are expected to stay for more than 48hrs in ICU and ability to understand and communicate and able to receive their medications orally or through a nasogastric tube during the ICU stay.
排除标准
- •Renal failure (dialysis dependence), Liver failure (Child-Pugh class C), Patients who don’t have the ability to understand and communicateâ€.
结局指标
主要结局
To assess the difference in the quality of sleep in patients receiving oral melatonin 5mg along with non-pharmacological measures versus those receiving non pharmacological measures alone as measured by the mean Richards-Campbell Sleep Questionnaire score
时间窗: ICU admission to discharge or death or 14days of ICU stay whichever is earlier
次要结局
- mean ICU length of stay(ICU admission to 14 days of ICU stay or till discharge or till death)
- Mean difference in number of good sleep days using RCSQ score(ICU admission to 14 days of ICU stay or till discharge or till death)
- Mean sleep hours measured with Actigraphy(ICU admission to 14 days of ICU stay or till discharge or till death)
- Mean Cortisol level measured at 8AM (Alternate day)(ICU admission to 14 days of ICU stay or till discharge or till death)
- Incidence of delirium using CAM-ICU-7 Score(ICU admission to 14 days of ICU stay or till discharge or till death)
- Mean patient ventilator days(ICU admission to 14 days of ICU stay or till discharge or till death)
- Re-intubation rates(ICU admission to 14 days of ICU stay or till discharge or till death)
- Mean consumption of Sedatives(ICU admission to 14 days of ICU stay or till discharge or till death)
- Mortality(ICU admission to 14 days of ICU stay or till discharge or till death)
研究者
Dr JeevaKumar R
All India Institute of Medical Sciences, Bhubaneswar