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临床试验/NCT06378710
NCT06378710已完成不适用

Haemodynamic and Respiratory Effects of a Low Positive End Expiratory Pressure Associated With a Fluid Challenge in Knee-chest Position- A Randomized Interventional Study

University Hospital, Caen2 个研究点 分布在 1 个国家目标入组 84 人开始时间: 2023年1月20日最近更新:
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
84
试验地点
2
主要终点
Number of occurrences of a MAP

研究概览

简要总结

The genu pectoral position is a surgical position used for spine surgery. This surgical position will lead to physiological hemodynamic and respiratory changes during the procedure.

The knee-pectoral position notably induces an increase in CRF and improves pulmonary ventilation/perfusion ratios. On the other hand, it has been shown that it is accompanied by a reduction in cardiac output of approximately 15% Protective perioperative ventilation including a tidal volume between 6 and 8 ml/kg of theoretical ideal weight, PEEP and alveolar recruitment maneuvers is applied in the operating room to reduce postoperative pulmonary complications. The application of high PEEP and the performance of recruitment maneuvers induce arterial hypotension through changes in intra- and transpulmonary pressures. However, investigators hypothesize that the deleterious hemodynamic effects of PEEP seem to counterbalance its beneficial respiratory effects in this particular position.

The combination of the effects of the knee-pectoral position and protective ventilation could be potentiated and be the cause of the sometimes severe arterial hypotension observed in clinical practice. Since this position improves pulmonary ventilation perfusion ratios, the investigators hypothesized that a lower PEEP and the elimination of intraoperative recruitment maneuvers could be beneficial from a hemodynamic point of view without being deleterious in terms of perioperative pulmonary complications. An exploratory study was carried out at the CAEN University Hospital in 2021 under the name PEEP POSTURE (CLERS Agreement No. 2198 of February 17, 2021) on 90 patients aiming to collect hemodynamic and respiratory parameters in 3 surgical positions: supine decubitus, ventral decubitus , pectoral genu. No difference was found in the evolution of respiratory compliance. On the other hand, a significant drop in SBP, DBP and MAP in the pectoral position was shown compared to the supine group as well as greater vascular filling.

The investigators therefore hypothesize that a reduction in PEEP and optimization of vascular filling could help reduce the adverse effects on blood pressure linked to the surgical position.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

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

  • Patient > 18 years old
  • Beneficiary of Social Security or CMU
  • Surgical operation under general anesthesia requiring a knee-pectoral position
  • Dated and signed informed consent

排除标准

  • BMI > 35 kg/m²
  • Hemodynamic instability before placing the knee in the pectoral position.
  • ASA class IV or V
  • Prolonged intervention > 2 hours
  • Lack of consent
  • Contraindications to the use of esophageal Doppler
  • Concomitant third-party clinical trial that may induce a hemodynamic or respiratory change in the patient

研究组 & 干预措施

control group

No Intervention

Standard PEEP (at 7 cmH2o), Vt standardized between [6- 8] ml/kg theoretical ideal weight. Taking NIBP every 3 minutes.

Optimized PEEP

Experimental

Optimized PEEP (at 2 cmH2O), filling according to VES monitoring by esophageal Doppler before reversal, Vt standardized between [6-8] ml/kg theoretical ideal weight. Taking NIBP every 3 minutes.

干预措施: Optimized PEEP (Procedure)

结局指标

主要结局

Number of occurrences of a MAP

时间窗: baseline

Number of occurrences of a MAP \<= 65mmHg per 3 min period occurring during the period of knee pectoral position

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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