Effects of Early Oral Diet After Cardiac Surgery: an Open Label Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 196
- 试验地点
- 2
- 主要终点
- simplified post operative nausea vomiting impact score.
研究概览
简要总结
This is an open label randomized controlled trial with two parallel groups to compare the effects of early initiation of oral diet to reduce the post-operative fasting time in adult patients undergoing cardiac surgery.Primary Objectives:
- To assess the impact of early and conventional diet on post-operative nausea and vomiting by calculating the simplified PONV (post-operative nausea and vomiting) impact score of patients after cardiac surgery, with a score >5 indicating clinically significant PONV.
- To study the impact of early versus conventional diet on gastrointestinal function by estimating the difference in timing of the first bowel movement in patients following cardiac surgery.
Secondary Objectives:
- To evaluate the effects of early versus conventional diet resumption on length of ICU stay among the patients following cardiac surgery in days.
- To compare the satisfaction levels of patients by visual analogue scale who resumed their oral diets early versus conventionally following cardiac surgery. The estimated sample size of 196 patients with routine post operative recovery after cardiac surgery will be randomized into early (interventional) and late (control) diet groups. Researchers will compare the early diet group with late diet group to see the effects.
详细描述
This is an open label randomized controlled trial with two parallel groups to compare the effects of early initiation of oral diet to reduce the post-operative fasting time in adult patients undergoing cardiac surgery. Assuming a incidence rate of post-operative nausea and vomiting of 40% in cardiac surgery (Sawatzky et al., 2014), and an anticipated incidence of clinically significant PONV using the simplified PONV impact scale of 20% (Myles et al., 2012), with a presumed 50% risk reduction with early feeding, a power of 80%, and alpha of 0.05, the minimum effective sample size would be 164 subjects (82 per arm). Assuming a drop out of 20%, the sample size was increased to 196 subjects (98 per arm).
Adult patients' status post-operative cardiac surgery in CTICU of Heart Hospital, after extubation, meeting inclusion criteria will be included in the study.
They will be divided into early and conventional diet groups. and randomized using web-based randomization to early diet (intervention arm) versus conventional diet (control arm) in 1:1 ratio. The patients of early group will be examined for water swallowing test (WST) at bedside after extubation. Before performing the WST, the patient must be evaluated for readiness including Awake, alert, cooperative, able to follow command, vital signs are stable, able to maintain at least 75-degree.
in upright position, the patient can cough effectively, the patient can stick out tongue and move to the left and right, the patient can breathe comfortable.
The patient's mouth will be cleaned, and the patient will be asked to drink each 5 ml of water (1 teaspoon) 3 times respectively. If the patient shows any abnormal signs, the test will be discontinued. If all steps are passed, then the patient will continue to drink the entire 90 ml of water from a cup or with a straw in sequential slowly and steadily swallowing without stopping (cup or straw can be held by clinician or patient). (Phothikun N, 2022).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients' post-operative status,
- •Post extubation (usually extubated within 4-6 hours after surgery) without any cognitive deficits, expected
- •Minimal chest drain (<100 ml/h), with
- •Awake, alert, oriented without any cognitive impairment
- •Able to pass water swallow test will be included in the study.
- •Exclusion Criteria
- •Major complicated cardiac surgeries (aortic dissection, surgeries involving mechanical circulatory support (ECMO or Ventricular assist devices).
- •Patients with profuse surgical /chest drain bleeding >100 ml/h for 3 consecutive hours in chest drain,
- •Patients undergo re-exploration sternotomy, cardiac tamponade and
- •Patients with cognitive impairment, drowsy
- •Absence of vocalization after extubation
- •Patients who fails in water swallow test for dysphagia after extubation
排除标准
- 未提供
结局指标
主要结局
simplified post operative nausea vomiting impact score.
时间窗: 24 hours
To assess the impact of early and conventional diet on post-operative nausea and vomiting by calculating the simplified PONV (post-operative nausea and vomiting) impact score of patients after cardiac surgery, with a score \>5 indicating clinically significant PONV.
Timing of bowel movements
时间窗: 5 days
To study the impact of early versus conventional diet on gastrointestinal function by estimating the difference in timing of the first bowel movement in patients of both groups following cardiac surgery.
次要结局
- length of ICU stays in days.(5 days)
- patient satisfaction(2 days)