NCT01403909撤回不适用
Effect of Pneumatic Intermittent Venous Compression on Fluid Volumes Infused During Major Abdominal Surgery in Non-obese American Soceity of Anesthesiologists (ASA) 1-3 Patients
Centre Hospitalier Universitaire de Nīmes2 个研究点 分布在 1 个国家开始时间: 2014年11月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- Volume fluids (ml)
研究概览
简要总结
The main objective of this study was to evaluate the effect of intermittent pneumatic venous compression on intra-operative fluid intake by comparing two groups of patients with or without intermittent pneumatic compression of the lower limbs.
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
- Double (Participant, 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
- •The patient must have given his/her informed and signed consent
- •The patient must be insured or beneficiary of a health insurance plan
- •Patient with ASA score 1-3
- •Body mass index < 30 kg/m^2
- •Patient is schelduled for major abdominal surgery (laparotomy without risk of haemorrhage whose duration is assumed to be greater than 120 min)
- •The patient passes from home, directly to the hospital, without schelduled hospitalization in another department
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
- •The patient is breastfeeding
- •The patient has a contra-indication for treatment necessary for the study
- •ASA score > 3
- •body mass index > 30 kg/m^2
- •Expected surgical time of < 120 minutes
- •Surgery with risk of hemorrhage
- •Surgery via celioscopy
- •The surgery require perineal access, thus rendering any blinding impossible
- •Hepatic surgery
- •Contra indication for intermittent venous compression
研究组 & 干预措施
With compression
Experimental
The patients randomized to this group will have intermittent pneumatic venous compression of the lower limbs during surgery.
干预措施: Intermittent pneumatic compression (Device)
Without compression
Active Comparator
The patients randomized to this group will not have intermittent pneumatic venous compression of the lower limbs during surgery. (Standard care)
干预措施: Standard care (Procedure)
结局指标
主要结局
Volume fluids (ml)
时间窗: End of surgery (expected mean of 2 hours)
The total volume of infused fluids (Ringer's Lactate and HES) delivered to the patient during surgery (ml)
次要结局
- Hypotensive episodes(end of surgery (expected mean of 2 hours))
- VEGF(end of surgery (expected mean of 2 hours))
- sFlt1(end of surgery (expected mean of 2 hours))
- Albumin(end of surgery (expected mean of 2 hours))
- Days of hospitalization(28 days)
- Hematocrit %(end of surgery (expected mean of 2 hours))
- Presence/absence of POSSUM complications(28 days)
- Number of days not in hospital(28 days)
- Prothrombin (%)(end of surgery (expected mean of 2 hours))
- Activated partial thromboplastin time(end of surgery (expected mean of 2 hours))
研究者
研究点 (2)
Loading locations...
相似试验
已完成
不适用
Compression Treatment Effects on Complications and Healing of Achilles Tendon RuptureRuptureSurgical Wound InfectionVenous ThrombosisVenous ThromboembolismNCT01317160Karolinska University Hospital150
已完成
不适用
Effects of Intermittent Pneumatic Compression Following an Officiall Soccer MatchIntermittent Pneumatic CompressionPlacebo - ControlNCT06636942University of Maia40
已完成
不适用
Intermittent Pneumatic Compression to Improve Revascularization OutcomePeripheral Arterial DiseaseNCT04250675Indiana University9
已完成
不适用
Hemodynamic Effects of Intermittent Pneumatic Compression for SportsSports Physical TherapyNCT06168565University of Maia23
尚未招募
不适用
Comparison of the Effects of Intermittent Pneumatic Compression, Graston Technique and Percussive TherapyRecovery MethodNCT06634862Okan University60