跳至主要内容
临床试验/NCT05626868
NCT05626868招募中不适用

Intraoperative Abdominal Pressure Measurement in Patients Undergoing Spine Surgeries in Prone Position as a Marker of Renal Damage

Medical University of Warsaw1 个研究点 分布在 1 个国家目标入组 24 人开始时间: 2021年5月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
24
试验地点
1
主要终点
Increase in intra abdominal pressure during surgery.

研究概览

简要总结

Background: Patients undergoing surgical operations in prone position do not have a measure of intra abdominal pressure as a standard procedure. Many of them could have elevated values of this parameter and could be exposed to possible renal damage due to a stiffening of the abdominal muscles while being positioned prone.

Purpose of study: Intraoperative intrabdominal pressure measurement and evaluation of correlation with possible postsurgical complications.

Methodology: Electronic device able to measure intra abdominal pressure is connected between a Foley catheter and a urinary collecting bag. During the procedure, values of the intra abdominal pressure are displayed on a monitor next to anaesthetic machine in real time. The numbers representing the pressure in mmHG are assessed and recorded.

Discussion: Possible correlation between intra abdominal hypertension and postsurgical complications in patients operated in prone position could be a foundation to further clinical trials and presurgical assessment of intraabdominal pressure.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Consent to participate in the study
  • Patients qualified for surgical stabilization of the spine in prone position

排除标准

  • No consent to participate in the study or inability to obtain consent
  • The inability to insert a urinary catheter
  • No indication for urinary catheter
  • Patients undergoing palliative treatment
  • Patients with advanced liver and kidney disease

结局指标

主要结局

Increase in intra abdominal pressure during surgery.

时间窗: Intraoperative

Change in intra abdominal pressure during surgery in prone position.

次要结局

  • Correlation of increased abdominal pressure with renal dysfunction assessed by urea.(From start of surgery to eight hours after the surgery.)
  • Correlation of increased abdominal pressure with renal dysfunction assessed by potassium.(From start of surgery to eight hours after the surgery.)
  • Correlation of increased abdominal pressure with mioglobin.(From start of surgery to eight hours after the surgery.)
  • Correlation of increased abdominal pressure with renal dysfunction assessed by creatinine.(From start to eight hours after the surgery.)

研究者

发起方
Medical University of Warsaw
申办方类型
Other
责任方
Sponsor

研究点 (1)

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