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临床试验/NCT00863044
NCT00863044已完成4 期

Impact of High Frequency Ventilation During Coronary Anastomosis in Off Pump Coronary Artery Bypass.

Montreal Heart Institute1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2009年11月1日最近更新:
适应症
干预措施

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
80
试验地点
1
主要终点
cerebral oxygen saturation

研究概览

简要总结

This study is to test the safety of high frequency-low volume ventilation during off pump coronary artery bypass as reflected in the near infrared spectroscopy values for cerebral oxygenation.

详细描述

Ventilatory protocol: Patients will be randomized to either the apnea group or the HFV group. In the HFV group the patients will be ventilated using a tidal volume of 1.5 ml per kg and a respiratory rate of 100 per minute for as long as the surgeon needs to perform the distal anastomosis of the coronaries.The same surgeon will perform all surgeries. In the Control group, ventilation will be stopped for the duration of the anastomosis as it's done currently. At all other times during the surgery, the ventilatory parameters will be adjusted to maintain a PaCO2 between 40 and 45 mmHg.

The anesthesia protocol for the off pump coronary artery bypass will be as follows: premedication will be left at the discretion of the anesthesiologist. In the operating room, the patient will be instrumented with a radial arterial line before induction. Induction will consist of a bolus of 1.0 mcg per Kg of Sufentanil. Anesthesia will be maintained with 1mcg per Kg per hour of Sufentanil. One per cent Isoflurane will be used as hemodynamic parameters allow. Rocuronium 0.7 mg per Kg will be used to facilitate endotracheal intubation. Following endotracheal intubation the patients will monitored with a pulmonary artery catheter and a femoral arterial line. A perfusionist will be on standby at all times for possible conversion to extracorporeal circulation.

Measures to effect:

Routine baseline laboratory investigations will be performed at admission of the patient to the ward.

Hemodynamic parameters:

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
None

入排标准

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

入选标准

  • •Age > 18 years.
  • •Patients able to give consent with knowledge of french or english language.

排除标准

  • •Patients undergoing emergency surgery.
  • •Patients with an intra aortic balloon pump.

研究组 & 干预措施

High frequency ventilation

Active Comparator

high frequency ventilation

干预措施: High frequency ventilation (Procedure)

Apnea

Placebo Comparator

lung ventilation will be stopped during distal anastomosis as is commonly done

干预措施: Apnea (Procedure)

结局指标

主要结局

cerebral oxygen saturation

时间窗: during surgery

次要结局

  • hemodynamic parameters(during surgery)

研究者

发起方
Montreal Heart Institute
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alain Deschamps

MD, PhD, FRCPC

Montreal Heart Institute

研究点 (1)

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