Automated Administration of Intravenous Fluids Guided by Dynamic Parameters and Cardiac Output During General Anesthesia: a Pilot Feasibility Study
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 30
- 试验地点
- 4
- 主要终点
- The percentage of fluid (crystalloid or colloid) administration changes per patient performed by the LIR system and approved / accepted by the participating anesthetist.
研究概览
简要总结
The main objective of this study is to demonstrate that the LIR (Learning Intravenous Resuscitator) Closed-Loop Fluid Administration System (hereafter the "LIR system"), a new device for the automated administration of intravenous fluids during major abominal surgery and which allows the reinjection of 250 ml of saline filling (crystalloid or colloid), maintains blood volume at values that are acceptable by the "gold standard", i.e. the anesthetist in charge of the patient.
详细描述
This is a prospective, bi-center, open "Phase II" type study on a medical device (the LIR system). It is the first trial of the device on humans.
The study, which begins at the signing of consent (made the day before or the day of surgery), ends when the patient leaves the hospital. The LIR system is used on a small population of patients under general anesthesia for the automated administration of intravenous fluids during major abdominal surgery by laparotomy or laparoscopy. Several criteria describing the fluids administered, cardiac output, blood pressure and other parameters will be identified during surgery.
This Phase II study is carried out in two, subsequent stages of size "n1" = 19 and "n" = 42.
Strengthening of security :
- The device will be used under the direct supervision of an anesthesiologist ; he / she can regain control instantly when needed .
- An independent oversight committee will be formed and consulted every 10 patients.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- 否
入选标准
- •The patient must have given his/her informed and signed consent
- •The patient must be insured or beneficiary of a health insurance plan
- •The patient will receive general anesthesia for a surgical procedure with the following characteristics: ----- planned abdominal surgery by laparotomy or laparoscopy with a probable duration> 2 hours ----- invasive monitoring of blood pressure ----- administration of crystalloid and colloid (HEA PM <150 kDa)
排除标准
- •The patient is participating in another study
- •The patient is in an exclusion period determined by a previous study
- •The patient is under judicial protection, under tutorship or curatorship
- •The patient refuses to sign the consent
- •It is impossible to correctly inform the patient
- •The patient is pregnant, parturient, or breastfeeding
- •The patient has a contraindication for a treatment used in this study: ----- Contraindications to the administration of HES MW <150 kDa ----- Patient classified NYHA> 2 ----- Allergy to HEA
- •The patient has a pacemaker
- •Surgery with cardiopulmonary bypass
- •Surgery on the skull
- •Patients with brain pathology (tumor, stroke, Parkinson's disease, ...)
- •Patients with a psychiatric disorder, severe depression or psychosis, as well as those receiving antipsychotic treatment
- •Limitations concerning the use of respiratory pulse pressure variation: cardiac arrhythmia, spontaneous ventilation, using a volume flow <7 ml / kg
研究组 & 干预措施
The study population
See inclusion/exclusion criteria.
Intervention: LIR
干预措施: Learning Intravenous Resuscitator (LIR) system (Device)
结局指标
主要结局
The percentage of fluid (crystalloid or colloid) administration changes per patient performed by the LIR system and approved / accepted by the participating anesthetist.
时间窗: Day 0, just after surgery
A change may be non-validated in the following two situations: 1. Stopping criteria when using the LIR system: * malfunction of the device * malfunction of the electric syringe (Agilia, Fresenius Kabi, Germany) * an abnormality of cardiac output measurement or appearance of a limitation to the use of pulse pressure variation (cardiac arrhythmia, spontaneous ventilation, tidal volume \<7 ml / kg of theoretical ideal weight). 2. Non-validation criteria for fluid administration despite a positive indication by the LIR device: If the answer to the two following questions are both yes, preventing the LIR device from acting is not theoretically justified, and the anesthesiologist must justify stopping the device and record the reason for his/her non-validation of the administration of fluid therapy. * The last fill increased cardiac output more than 15%? yes/no * The prediction parameter for filling response (pulse pressure variation) indicates vascular filling? yes/no
次要结局
- Stroke volume throughout surgery(Day 0 (just after surgery))
- The number of times the anesthetist in charge of the patient had to intervene with the fluid administration (cristalloid or colloid) system/device.(Day 0, just after surgery)
- The total volume of HEA and crystalloid infused during the preload optimizations and cardiac output(Day 0, just after surgery)
- Minimum blood pressure during surgery(Day 0, just after surgery)
- The total amount of intravenous fluids administered during surgery(Day 0, just after surgery)
- The total amount of crystalloid administered for basic inputs during surgery(Day 0, just after surgery)
- The mean cardiac output during surgery (liters of blood per minute)(Day 0, just after surgery)
- Cardiac output at the end of surgery (liters of blood per minute)(Day 0, just after surgery)
- The percent % variation in cardiac output during surgery(Day 0, just after surgery)
- % variation in blood pressure during surgery(Day 0, just after surgery)
- Blood pressure at the end of surgery(Day 0, just after surgery)
- The percentage of time spent in hypotension.(Day 0 (at the end of surgery))
- The number of fluid administration modifications (cristalloid or colloid) performed by the device(Day 0, just after surgery)
- The maximum cardiac output during surgery (liters of blood per minute)(Day 0, just after surgery)
- The minimum cardiac output during surgery (liters of blood per minute)(Day 0, just after surgery)
- The minutes required to achieve maximized cardiac output.(Day 0 (at the end of surgery))
- The number of hypotension and hypertension episodes requireing treatment.(Day 0 (just after surgery))
- Pulse pressure variation throughout surgery(Day 0 (just after surgery))
- The occurrence of postoperative complications defined by POSSUM criteria(Day 0 to 3; discharge from the post-intervention monitoring room)
- Medical device malfunctions: presence/absence(Day 0 to 3; discharge from the post-intervention monitoring room)
- Mean blood pressure during surgery(Day 0, just after surgery)
- Maximum blood pressure during surgery(Day 0, just after surgery)
- Stroke volume variation(Day 0 (just after surgery))
- Admission to ICU; yes/no(Day 0 to 3; discharge from the post-intervention monitoring room)
- The period between the end of surgery and the recovery of a liquid diet(Hospital discharge; expected maximum of 28 days)
- The period between the end of surgery and the resumption of solid food(Hospital discharge; expected maximum of 28 days)
- The percentage of time during which the LIR system maintained an optimal/maximal cardiac output.(Day 0 (at the end of surgery))
- Blood lactate(Day 0 (at the end of surgery))
- Length of hospital stay(Hospital discharge; expected maximum of 28 days)
- Creatinemia(Day 5)
- % oxygen saturation of central venous blood(Day 0 (at the end of surgery))
- Intraoperative urine output(Day 0 (at the end of surgery))
- The period between the end of surgery and the recovery of audible gastrointestinal transit (auscultation; gas and stool)(Hospital discharge; expected maximum of 28 days)
- Length of stay in ICU(Day 0 to 3; discharge from the post-intervention monitoring room)
- The period between the end of surgery and the recovery of intestinal transit(Hospital discharge; expected maximum of 28 days)