The Effect of Abdominal Massage on the Gastric Residual Volume in Adult Patients Admitted in Intensive Care Unit: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Gastric Residual Volume
研究概览
简要总结
The goals of this randomized controlled trial are:
- To determine the mean gastric residual volume in ICU admitted adult patients before and after intervention.
- To compare the gastric residual volume between the intervention and control group.
Participants will be randomized in two groups (intervention and control group)
Intervention group:
The intervention period will be 3 days for intervention group. These patients will receive 20 minutes of abdominal massage twice a day, and the interval between two massages will be 2 hours. The outcome variable variable gastric residual volume will be measured every day, before the intervention and 1 hour after the second massage. the GRV will be measured in ml (via feeding syringe) and marked on checklist.
Control group The control group will receive standard/usual care The abdominal massage technique will consist of five steps based on tensegrity principle
详细描述
Food intolerance is one of the major problems of intensive care unit (ICU) admitted patients, receiving enteral nutrition. An important nursing priority for these patients is the prevention and management of food intolerance. This necessitates the use of techniques and procedures for increasing the rate of gastric emptying, and so enhancing tolerance to this nutritional support modality. Abdominal massage is a method that has shown to improve many digestive functions such as constipation and gastric residual volume (GRV), but a small number of studies have been conducted on NG fed patients in intensive care units, and occasionally, contradictory findings have been found. Furthermore, more studies were recommended to reach a definite conclusion on this intervention. The aim of this study is to determine the effect of abdominal massage on the gastric residual volume in patients hospitalized in intensive care units in a tertiary care hospital, Lahore. It is hypothesized that ICU admitted patients who will receive abdominal massage will have a difference in gastric residual volume than patients who will not.
Study Design A randomized controlled trial (RCT). Study setting The study will be conducted at Intensive care units of Jinnah Hospital, Lahore. Study Population Patients having nasogastric tube (NGT) for feeding and admitted in ICU with GCS below 7.
Sample size A sample size of 34 patients is calculated by using the formula of comparing means between two group and by taking power of study 80%, confidence level 95% ,mean gastric residual volume of intervention group 97.30 ml, mean gastric residual volume of control group 143.46 ml, standard deviation of gastric residual volume of intervention group 54.06 ml and standard deviation of gastric residual volume of control group = 39.93 ml.
Sampling technique patients will first be selected by non-probability convenient sampling. Then patients will be randomized into two groups by lottery method (17 patients in each group).
Data will be collected by using a researcher-designed checklist which will consist of two parts:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients having NG tube (for check the GRV).
- •glasgow coma scale less than 7 (because usually these patients need gavage)
- •patients having age 18-60 years.
排除标准
- •Patients receiving pro-kinetic medications (to avoid interfering with the massage effects)
- •Patients having abdominal radiotherapy during last 6 weeks.
- •Patients with abdominal aortic aneurysm and undergoing radiotherapy
- •Patients having abdominal surgery.
结局指标
主要结局
Gastric Residual Volume
时间窗: before and after intervention ( 3 hours duration)
Gastric residual volume will be measured in ml by aspiration of gastric contents.
次要结局
未报告次要终点
研究者
Mahwish Javeed
Principal Investigator
University of Health Sciences Lahore