Effect Of Protocolised Early Mobilisation Versus Routine Icu Care On Functional Outcome And Sarcopenia In Critically Ill Patients - A Prospective Randomised Control Study
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Functional status at ICU discharge: measured by ICU mobility scale
研究概览
简要总结
This study is a randomised parallel group active controlled trial to determine whether protocolised early mobilization strategy improves functional outcome and reduces sarcopenia in critically ill patients compared to routine ICU care that will be conducted in department of critical care medicine in Jubilee mission medical college and research institute. The primary outcome will be to determine functional outcome by assessing ICU Mobility score at time of discharge from ICU and to compare rectus femoris thickness and cross sectional area measured with bedside USG at admission and time of discharge from ICU. The secondary outcomes will be to measure length of stay in ICU, ventilator free days and complications during mobilisation.
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 90.00 Year(s)（—）
- 性别
- All
入选标准
- •ICU patients who are expected to stay in ICU for more than 48 hours and able to initiate mobilization within 48 hours of ICU admission.
排除标准
- •Hemodynamic instability, requiring more than 0.8mcg per hour of noradrenaline or comparable inotropic support, severe pulmonary hypertension, bradycardia requiring treatment or dependent rhythm with pacemaker, tachyarrhythmia ventricular rate more than 120 beats per minute, cardiac ischemia Fio2 requirement more than 60 percent , PEEP more than 10 , prone positioning Polytrauma with traumatic brain injury with risk of raised intracranial pressure , unstable spine injuries, unstable pelvis or long bone fractures, blunt or open trauma chest and abdomen with active bleeding risk Active neurological concern , RASS score other than -2 to +1, active management of elevated intracranial pressure, uncontrollable seizures Patients with devices such as Femoral IABP or ECMO or pulmonary artery catheter or another cardiac monitoring device or femoral sheaths Previously bedridden patients or pre-existing neuromuscular disease or severe physical disability Any other contraindication to mobilisation.
结局指标
主要结局
Functional status at ICU discharge: measured by ICU mobility scale
时间窗: ICU mobility scale - at ICU admission and discharge from icu | Change in rectus femoris muscle thickness and cross-sectional area - at ICU admission, day 3, day 7 , day of discharge from ICU
Change in rectus femoris muscle thickness and cross-sectional area
时间窗: ICU mobility scale - at ICU admission and discharge from icu | Change in rectus femoris muscle thickness and cross-sectional area - at ICU admission, day 3, day 7 , day of discharge from ICU
次要结局
- ICU length of stay(Ventilator free days)
研究者
Abhijith S
Jubilee mission medical college and research institute