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临床试验/NCT04024410
NCT04024410已完成不适用

Optimal Positive End-expiratory Pressure (PEEP) in Prone Position During Spine Surgery. A Prospective Observational Study

Parc de Salut Mar1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年6月3日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
20
试验地点
1
主要终点
Change in Positive End-Expiratory Pressure (PEEP)

研究概览

简要总结

Background:

There is a lack of studies regarding Optimal (best) positive end-expiratory pressure (PEEP) in prone position during surgery, and its relation with optimal PEEP in supine position.

Hypothesis:

In patients undergoing scheduled spinal surgery, optimal PEEP in the prone position is lower than optimal PEEP in the supine position.

Aims:

To assess the difference optimal PEEP in supine vs. prone positions in patients undergoing spine surgery.

To evaluate the changes in optimal PEEP in prone position throughout the surgical procedure.

Methods:

Observational study, one center. Main variable: optimal PEEP. Secondary variables: PaO2, pCO2 and dynamic compliance (Crd) in prone and supine position.

详细描述

Recruitment: Patients scheduled for spine surgery were Main outcome: Optimal PEEP determined after a pulmonary recruitment manoeuvre in supine and in prone position and every hour during the surgery in prone position.

Secondary outcomes: Pulmonary compliance, blood gas analysis and hemodynamic parameters

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

  • Age ≥18 years.
  • Spine prone surgery lasting ≥2 hours.
  • Absence of known pulmonary pathology.

排除标准

  • Pregnancy or lactation.
  • Contraindication to alveolar recruitment maneuvers (risk of barotrauma, hemodynamic instability).
  • Body mass index (BMI) >
  • Heart failure defined as IC <2.5 L/min/m2 and/or inotropic support requirements prior to surgery.
  • Diagnosis or suspicion of intracranial hypertension (intracranial pressure >15 mmHg).

结局指标

主要结局

Change in Positive End-Expiratory Pressure (PEEP)

时间窗: From determination of optimal PEEP until the first hour and then every hour, assessed up to the end of surgery (maximum 6 hours)

Variation of Positive End-Expiratory Pressure (cmH2O) during surgery in prone position with respect to PEEP value at 10 minutes after positioning

Positive End-Expiratory Pressure (PEEP)

时间窗: 10 minutes after positioning

Positive End-Expiratory Pressure (cmH2O) in prone position

次要结局

  • Arterial oxygen pressure (PaO2)(10 minutes after positioning)
  • Change in static compliance(Measured at the same time as Auto PEEP until the first hour and then every hour, assessed up to the end of surgery (maximum 6 hours))
  • Arterial carbon dioxide pressure (PaCO2)(10 minutes after positioning)
  • Change in arterial carbon dioxide pressure (PaCO2)(Measured at the same time as Auto PEEP until the first hour and then every hour, assessed up to the end of surgery (maximum 6 hours))
  • Static compliance(10 minutes after positioning)
  • Change in arterial oxygen pressure (PaO2)(Measured at the same time as Auto PEEP until the first hour and then every hour, assessed up to the end of surgery (maximum 6 hours))

研究者

发起方
Parc de Salut Mar
申办方类型
Other
责任方
Sponsor

研究点 (1)

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