跳至主要内容
临床试验/NCT02450019
NCT02450019已完成不适用

Protective Ventilation in Neurosurgery, a Pilot Study

IRCCS San Raffaele1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2015年5月1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
40
试验地点
1
主要终点
Intracranial pressure measured in mmHg

研究概览

简要总结

The purpose of this study is to assess the effect size and variability of dural tension measured as intracranial pressure (ICP) below the dura of the surgical field in patients undergoing elective supra-tentorial surgery for brain neoplasms in patients alternatively ventilated with traditional high-volume-no-PEEP ventilation and protective low-volume-low-PEEP ventilation.

详细描述

The role of mechanical ventilation in patients undergoing general anesthesia is worldwide well known but it has been associated with dangerous effects such as pulmonary complications, increasing postoperative morbidity and mortality. Lung-protective ventilation using low tidal volume and positive end-expiratory pressure (PEEP), can reduce morbidity and mortality in patients with acute respiratory distress syndrome and is now considered a strong recommendation in patients undergoing general anesthesia. At the moment there are no guidelines that define which kind of ventilation should be used.

Patients without acute lung injury are still ventilated with large -and perhaps too large- tidal volumes. A recent multicenter randomized controlled trial has concluded that the use of a lung-protective ventilation strategy in intermediate-risk and high-risk patients undergoing major abdominal surgery was associated with improved clinical outcomes and reduced health care utilization . A multicentre randomized controlled trial on mechanical ventilation during general anesthesia for open abdominal surgery has concluded that an intraoperative protective ventilation strategy should include a low tidal volume and low PEEP, without recruitment maneuvers. In 52 patients undergoing general anesthesia for open thoracic surgery lung protective ventilation was associated with better intraoperative and postoperative oxygenation, and shorter duration of postoperative mechanical ventilation from ICU admission to its withdrawal.

In conclusion protective ventilation, with low tidal volumes and low PEEP, seems to be the gold standard for intra-operative mechanical ventilation during general anesthesia.

Mechanical ventilation represents an important tool to obtain cerebral de-bulking during neurosurgery by maintaining moderate hypocapnia and positive intra-thoracic pressure the lowest possible. For these reasons the application of PEEP with high tidal volume has been historically seen as unfavourable by neuro-anesthesiologists and neurosurgeons fearing transmission to intracranial compartment of high venous pressure values with consequent brain swelling and eventually cerebral perfusion pressure reduction.

Nevertheless, recent studies suggested that in patients with traumatic brain injury (TBI) PEEP seems to be well tolerated without deleterious intracranial effect and its role in the context of a protective ventilation protocol associated with low tidal volume, so with low expected intra-thoracic pressures, has never been studied in patients undergoing to general anesthesia for intracranial surgery of neoplasms.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Prevention
盲法
Double (Participant, Care Provider)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Elective surgical removal of a supra-tentorial neoplasm conditioning mass effect defined as:
  • •Median line shift at preoperative CT scan ≥ 5mm
  • •Cortical brain effacement at preoperative CT scan

排除标准

  • •Age < 18 yrs or > 80 yrs.
  • •BMI > 30
  • •Pregnancy.
  • •Refusal to sign the informed consent.
  • •Emergency surgery.
  • •Respiratory co-morbidities (clinical evidence or history of COPD, asthma, interstitial pneumopathies, previous thoracic surgery).

研究组 & 干预措施

Traditional to protective ventilation

Other

Traditional ventilation will be set with 9 ml/kg with predicted body weight of tidal volumes and no PEEP. Arterial CO2 partial pressure will be maintained between 30 and 35 mmHg. After intracranial pressure measurement ventilation will be switched to protective.

干预措施: Traditional to protective ventilation (Procedure)

Protective to traditional ventilation

Other

Protective ventilation will be set with 7 ml/kg tidal volume, 5 cm H2O PEEP, and 0.4 inspired O2 fraction (FiO2). Arterial CO2 partial pressure will be maintained between 30 and 35 mmHg. After intracranial pressure measurement ventilation will be switched to traditional.

干预措施: Protective to traditional ventilation (Procedure)

结局指标

主要结局

Intracranial pressure measured in mmHg

时间窗: Outcome 1 is assessed before the incision of dura mater (mean 1 hour).

Primary endpoint: to assess the effect size and variability of dural tension measured as intracranial pressure (ICP) below the dura of the surgical field in patients undergoing elective supra-tentorial surgery for brain neoplasms in patients alternatively ventilated with traditional high-volume-no-PEEP ventilation and protective low-volume-low-PEEP ventilation.

次要结局

  • Dural tension measured by a two point scale (acceptable/unacceptable).(Outcome 2 is assessed before the incision of dura mater (mean 1 hour).)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Marco Gemma

MD Anaesthesist

IRCCS San Raffaele

研究点 (1)

Loading locations...

相似试验