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临床试验/NCT07632027
NCT07632027尚未招募不适用

The BAROLO Study Bedside Assessment of Right Ventricular Output Lying in Prone Or Supine Position. Hemodynamic Changes Due to Prone Position in Patients After Cardiac Surgery - a Prospective Randomized Controlled Trial Evaluating the Effect of Prone Position on Right Heart Function

Sahlgrenska University Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2026年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
80
试验地点
1

研究概览

简要总结

Right ventricular failure (RVF) is a common complication to cardiac surgery, which is associated to mortality, kidney failure, stroke, prolonged mechanical ventilation and ICU stay. The right ventricle is particularly vulnerable to an increased afterload. By increasing pulmonary vascular resistance (PVR), atelectasis might mitigate a negative effect on the right ventricle.

Recruitment maneuvers have been shown to resolve atelectasis and improve hemodynamics by increasing cardiac output and lowering PVR. However these maneuvers transiently raise airway pressures, which in turn increases right ventricular afterload, a situation often poorly tolerated by patients with RVF.

Prone position is used in patients with respiratory failure and has been shown to decrease mortality in patients with ARDS. Prone position decreases atelectasis and moves ventilation dorsally. In ARDS it also seems to mediate beneficial hemodynamic effects such as an increase in cardiac output and a decrease in PVR.

The investigators hypothesis is that prone position early after cardiac surgery will increase cardiac output by recruitment of atelectasis and thereby decrease PVR.

详细描述

Recruitment and consent:

Patients will be screened for participation no later than the day before surgery. Potential participants will be given written and verbal information regarding the study and time to ask questions and consider their participation.

Randomization:

After end of surgery, at baseline in the ICU, patients will be randomly allocated (1:1 ratio) to supine position and prone position. Block randomization with variable block sizes will be performed with sequentially numbered, opaque, sealed envelopes. All performed by Statistiska konsultgruppen. Patient stratification according to cardiac index at end-surgery will be performed to ensure similar allocation of patients with cardiac index <2.2 L/min/m2 in each group. The investigator who enrolls study participants will not have access to the random allocation sequence.

Sample Size:

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

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

  • Scheduled for cardiac surgery using cardiopulmonary bypass

排除标准

  • Emergency surgery
  • In need of secondary surgery
  • Advanced grown up congenital heart disease
  • Pulmonary disease
  • Hemodynamic instability with Norepinephrine >0.4mcg/kg/min
  • Any condition which, in the judgement of the investigator, might increase the risk to the patient

研究者

发起方
Sahlgrenska University Hospital
申办方类型
Other
责任方
Principal Investigator
主要研究者

Viktor Erbring

Principal Investigator, MD, PhD student, Consultant in Cardiothoracic Anaesthesia and Intensive Care.

Sahlgrenska University Hospital

研究点 (1)

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