跳至主要内容
临床试验/NCT02262039
NCT02262039已完成不适用

Reducing Operative and Post-operative Morbidity in Living Kidney Donors With the Airseal System: A Randomized Control Trial

Yale University2 个研究点 分布在 1 个国家目标入组 41 人开始时间: 2014年8月最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
41
试验地点
2
主要终点
Narcotic Use (mg)

研究概览

简要总结

The purpose of this study is to determine if the Airseal System will reduce post-operative pain and reduce the need for narcotics in laparoscopic living kidney donor surgeries.

详细描述

Our hypothesis is that Airseal Insufflation System will provide reduced mean operative insufflation pressure and operative mean ETCO2, resulting in improved post-operative pain control and improved operative safety.

The Airseal System has demonstrated decreased variability in intra-abdominal pressure, less post-operative shoulder pain, lower mean ETCO2 and reduced narcotic pain administration. These metrics have been demonstrated in human subjects undergoing gynecologic, urologic and bariatric procedures. The established benefits in a human model provide a foundation for translating this technology to living kidney donors. The advantage lies in the ability to improve pain-related outcomes in this population, which translates into increased living donation; the single solution to reduce mortality for patients suffering from end-stage kidney disease.

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
Single (Participant)

入排标准

性别
All
接受健康志愿者

入选标准

  • Any living donor who has been approved to donate a kidney is eligible to participate.

排除标准

  • 未提供

研究组 & 干预措施

Conventional Pressure

Active Comparator

Conventional Insufflation with 15mmHg target pressure

干预措施: Conventional pressure (Device)

Low Pressure (VTI)

Experimental

Valveless recirculating insufflation (VTI) with 10mmHg target pressure

干预措施: Valveless recirculating insufflation (VTI) (Device)

结局指标

主要结局

Narcotic Use (mg)

时间窗: Operative and Post-operative (until time of discharge, typically 2-4 days)

Total Morphine Equivalent - mean in mg

次要结局

  • Subjective Pain Score(12 hours post-op)
  • Mean ETCO2(intraoperative)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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