Preoperative Oral Hydration in the Ambulatory Arthroplasty Population :A Single-Blinded Randomized Control Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 312
- 试验地点
- 1
- 主要终点
- Length of hospital stay in hours
研究概览
简要总结
The purpose of this study is to investigate if the consumption of a complex carbohydrate drink preoperatively, decreases the length of stay and causes for failure to launch in patients undergoing ambulatory total joint arthroplasty.
详细描述
The way total joint arthroplasty is practiced continues to evolve as CMS removed total hip arthroplasty (THA) from the inpatient-only list and added total knee arthroplasty (TKA) to the ASC Covered Surgical Procedures List (CPL) in 2020. Thus, surgeons must find subtle interventions that improve patient outcomes while minimizing the risk of adverse reactions. Current literature has not assessed the influence of preoperative hydration, using a complex carbohydrate drink, on the same-day discharge rate and causes for failure to launch. Considering variabilities in perioperative fluid management leading to postoperative nausea, vomiting, and dizziness, the investigators seek to reduce the incidence of these events by optimizing patients using a preoperative oral hydration protocol, reducing the length of stay, and improving same-day discharge rates.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Candidates for ambulatory total knee arthroplasty
- •Candidates for ambulatory total hip arthroplasty
- •Candidates for ambulatory revision knee arthroplasty (liner exchange only)
- •Candidates for ambulatory revision hip arthroplasty (liner exchange only)
- •Case scheduled before noon (12 pm)
- •Patient agrees to same-day discharge and has a responsible adult to spend the night on the day of discharge
排除标准
- •BMI less than 18.5 or greater than 37.0
- •Patients with diabetes, chronic kidney disease, clotting disorders, or neurological conditions preventing control of the affected limb.
- •Pregnant women
- •Patients scheduled as ambulatory due to insurance mandates
- •Patients with a history of active ischemia, significant valvular disease, significant arrhythmias, obstructive sleep apnea as per Hospital for Special Surgery guidelines, chronic opioid dependence (chronic daily opioid use for six or more months), and glomerular filtration rate < 60ml/min.
研究组 & 干预措施
Complex Carbohydrate Drink Group
The patients will drink a 400ml drink that contains 50g of complex carbohydrates, 3 hours prior to the surgery. The drink will be given once at the preoperative holding area. Patients are not allowed to eat solid foods after 12am the morning of surgery and can only drink clear fluids up to 3 hours prior to the surgery.
干预措施: Complex Carbohydrate Drink (Dietary Supplement)
No-Complex Carbohydrate Drink Group
These patients will follow normal institutional preoperative fluid management guidelines, this consist of no solid foods after 12am the morning of surgery. Patients are allowed to drink clear liquids (water, clear fruit juices, coffee) from 12am the morning of surgery up to 3 hours prior to the surgery.
结局指标
主要结局
Length of hospital stay in hours
时间窗: From admission to discharge, up to 1 week
Length of hospital stay in hours, assess by medical record.
次要结局
- Total distance walked(From admission to discharge, up to 1 week.)
- Orthostatic hypotension episodes(During physical therapy attempts, from admission to discharge.)
- HOOS JR Score(The morning of surgery and at the first post-operative visit, up to 4 months post-op.)
- KOOS JR Score(The morning of surgery and at the first post-operative visit, up to 4 months post-op.)
- In-house costs(From admission to discharge, up to 1 week.)
- Urine osmolality(Measured preoperatively the morning of surgery.)
- Same day discharge rate(Through study completion, an average of 3 months.)
- Number of stairs climbed(From admission to discharge, up to 1 week.)
- Urine specific gravity(Measured preoperatively the morning of surgery.)
- VR-12 Score(The morning of surgery and at the first post-operative visit, up to 4 months post-op.)
- Number of physical therapy sessions attempted(From admission to discharge, up to 1 week.)
研究者
Jose Rodriguez
Professor of Clinical Orthopaedic Surgery
Hospital for Special Surgery, New York