Fluid Responsiveness in the Postoperative Patient: a Prospective Study
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 245
- 主要终点
- FR assessed by the ccNexfin system, anytime VE is ordered by the treating physician
研究概览
简要总结
The aim of this study is to determine the prevalence of Fluid Responsiveness (FR) (SV increases by at least 15% after Volume Expansion, VE) in postoperative patients admitted on a surgical ward after elective abdominal, thoracic and esophageal surgery
详细描述
Perioperative care
Preoperative Period
As per usual practice, the patient's staff surgeon will provide directives for preoperative fasting and fluid intake. These patients are encouraged to drink up to two hours before hospital admission, and also receive preoperative carbohydrate drinks the night before (100 grams), and the morning of surgery (50 grams) when indicated. Additionally, routine use of mechanical bowel preparation is avoided, and is prescribed only in selected cases. The patient's weight will be obtained upon arrival in the operating room.
Anesthetic and analgesic management
Anesthetic management and choice of postoperative analgesia will be as per usual care, at the discretion of the staff anesthesiologist in-charge of the case. An arterial line or central venous line may be inserted, and Goal Directed Fluid Therapy (GDFT) employed if deemed necessary.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Screening
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
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 undergoing major elective thoracic and abdominal surgeries, the latter group including upper gastrointestinal, esophageal, and colorectal procedures,
- •Patients treated with surgery-specific enhanced recovery programs (ERPs), implemented in 2010 at the Montreal General Hospital for colorectal surgery, and subsequently developed at the same institution for thoracic surgery
排除标准
- •Age <18 years
- •Emergency surgery
- •Patients who do not understand, read or communicate in either French or English
- •Chronic kidney disease
- •Congestive heart failure
- •Severe aortic stenosis
- •Patients not in sinus rhythm
- •Patients requiring fluid restriction for any reason
- •Known peripheral vascular disease or Raynaud's phenomenon
- •Septic patients
- •Acute circulatory shock
研究组 & 干预措施
Postoperative elective surgical patients
Patients undergoing major elective thoracic and abdominal, the latter group including upper gastrointestinal, esophageal, and colorectal procedures. In this group FR will predicted by administering a fluid challenge of 250 ml of Lactated Ringer's solution and measuring SV with the ccNexfin
干预措施: Fluid challenge (250 ml Lactated Ringer's solution) (Drug)
结局指标
主要结局
FR assessed by the ccNexfin system, anytime VE is ordered by the treating physician
时间窗: For the entire duration of hospital stay (an average of 3 days for patients undergoing colorectal surgery, 4 days for patients undergoing thoracic surgery, and 6 days for patients undergoing esophageal surgery)
FR (SV increases by ≥ 15% ) FR will be measured 1 minute after the completion of VE
次要结局
- Prediction of FR(For the entire duration of hospital stay (an average of 3 days for patients undergoing colorectal surgery, 4 days for patients undergoing thoracic surgery, and 6 days for patients undergoing esophageal surgery))
- FR assessed by the ccNexfin system, at the arrival in PACU and daily on the surgical floor(At the arrival in PACU and daily for the entire duration of hospital stay (an average of 3 days for patients undergoing colorectal surgery, 4 days for patients undergoing thoracic surgery, and 6 days for patients undergoing esophageal surgery))
- Dynamic Arterial Elastance (absolute number), anytime VE is ordered by the treating physician(Before the fluid challenge, for the entire duration of hospital stay (an average of 3 days for patients undergoing colorectal surgery, 4 days for patients undergoing thoracic surgery, and 6 days for patients undergoing esophageal surgery))
- Heart rate (beat per minute)(At the arrival in PACU and daily for the entire duration of hospital stay (an average of 3 days for patients undergoing colorectal surgery, 4 days for patients undergoing thoracic surgery, and 6 days for patients undergoing esophageal surgery))
- Arterial Blood Pressure (mmHg)(At the arrival in PACU and daily for the entire duration of hospital stay (an average of 3 days for patients undergoing colorectal surgery, 4 days for patients undergoing thoracic surgery, and 6 days for patients undergoing esophageal surgery))
- Central Venous Pressure (CVP)(mmHg)(At the arrival in PACU, if available)
- Urine output(At the arrival in PACU,and daily for the entire duration of hospital stay (an average of 3 days for patients undergoing colorectal surgery, 4 days for patients undergoing thoracic surgery, and 6 days for patients undergoing esophageal surgery))
- Respiratory Rate (breaths per minutes)(At the arrival in PACU,and daily for the entire duration of hospital stay (an average of 3 days for patients undergoing colorectal surgery, 4 days for patients undergoing thoracic surgery, and 6 days for patients undergoing esophageal surgery))
- Peripheral Oxygen Saturation (%)(At the arrival in PACU,and daily for the entire duration of hospital stay (an average of 3 days for patients undergoing colorectal surgery, 4 days for patients undergoing thoracic surgery, and 6 days for patients undergoing esophageal surgery))
- Amount of perioperative intravenous fluids administered(At the arrival in PACU and daily for the entire duration of hospital stay (an average of 3 days for patients undergoing colorectal surgery, 4 days for patients undergoing thoracic surgery, and 6 days for patients undergoing esophageal surgery))
- 24 hour postoperative weight gain(Daily for the entire duration of hospital stay (an average of 3 days for patients undergoing colorectal surgery, 4 days for patients undergoing thoracic surgery, and 6 days for patients undergoing esophageal surgery))
- Quality of recovery measured by the Quality of Recovery Score(Daily for the entire duration of hospital stay (an average of 3 days for patients undergoing colorectal surgery, 4 days for patients undergoing thoracic surgery, and 6 days for patients undergoing esophageal surgery))
- Number of patients with at least one postoperative complication(Daily for the entire duration of hospital stay (an average of 3 days for patients undergoing colorectal surgery, 4 days for patients undergoing thoracic surgery, and 6 days for patients undergoing esophageal surgery))
- Number of postoperative complications(Daily for the entire duration of hospital stay (an average of 3 days for patients undergoing colorectal surgery, 4 days for patients undergoing thoracic surgery, and 6 days for patients undergoing esophageal surgery))
- Length of hospital stay(Daily for the entire duration of hospital stay (an average of 3 days for patients undergoing colorectal surgery, 4 days for patients undergoing thoracic surgery, and 6 days for patients undergoing esophageal surgery))
- 30 days readmission rates(30 days after primary hospital discharge following surgery)
- Type of postoperative complication(Daily for the entire duration of hospital stay (an average of 3 days for patients undergoing colorectal surgery, 4 days for patients undergoing thoracic surgery, and 6 days for patients undergoing esophageal surgery))
- Readiness to be discharged(Daily for the entire duration of hospital stay (an average of 3 days for patients undergoing colorectal surgery, 4 days for patients undergoing thoracic surgery, and 6 days for patients undergoing esophageal surgery))
研究者
Gabriele Baldini, MD, MSc, Assistant Professor
Assistant Professor
McGill University Health Centre/Research Institute of the McGill University Health Centre