跳至主要内容
临床试验/NCT01522222
NCT01522222已完成不适用

Effect of Continuous Mechanical Ventilation During Cardiopulmonary Bypass on The Lung Mechanics: A Prospective Evaluation

Aurora BayCare Medical Center2 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2010年7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
发起方
入组人数
40
试验地点
2
主要终点
Post-surgical lung function, compliance, tissue oxygenation, and radiographic changes indicative of atelectasis.

研究概览

简要总结

To demonstrate that using continuous mechanical lung ventilatory support in combination with Positive End Expiratory Pressure (PEEP)during open heart surgery will improve lung function and decrease lung complications after surgery.

详细描述

This is a prospective, randomized, blinded study with a control group. The study group will receive mechanical ventilatory support during CBB, which consists of a preset/predetermined tidal volume, respiratory rate, positive pressure at the end of expiration and FIO2. The control group will receive CPB without additional mechanical ventilatory support during surgery, which at present is the standard of care.

The difference between the study and the control group will occur during the time the heart is arrested and the lungs, under present standard of care, are no longer ventilated. It is at this point in time that those in the study group will continue to receive ventilation, intermittent positive pressure ventilation, while their heart is arrested. The subjects will have their lungs ventilated six times per minute with a tidal volume equal to 7-10 milliliters per kilogram. This range, when combined with a consistent PEEP of 5cm of water pressure, will allow for the peak inspiratory pressure to be maintained at or below 40cm of water pressure. In addition, the FIO2 will remain consistent at the same level that was needed to maintain the pulse oximetry at 94% as well as the end-tidal CO2 at 35mmHg. The values mentioned for this study have been chosen based on not only investigator preference, but also on what is considered "minimally necessary" to prevent atelectasis. Multiple studies have been done utilizing PEEP at 5 and 10 cm of water pressure. With the exception of the potential for mechanical ventilation during the CBP, the care of the subject, regardless of the group randomized into, will be the same. We will in all other aspects continue to utilize the current standard of care.

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • any patient of any gender, any age with known coronary artery disease that will undergo elective Coronary Artery Bypass Grafting (CABG) and will require CPB as part of his/her operative technique.

排除标准

  • documented ejection fraction (either by echocardiogram or by cardiac catheterization) equal to or below 20%
  • patients with cardiac valvular disease
  • patients with a spirometry measurement that demonstrates an FEV1/FVC ratio below 60%
  • patients with chronic renal failure who require dialysis or
  • those who have experienced an allergic reaction to anesthesia in the past
  • patients with a history of lung infiltrate on chest X-ray prior to surgery or a history of asthma
  • Women who are pregnant are excluded

研究组 & 干预措施

Control

No Intervention

half of the study subjects will receive standard of care during their open heart surgery.

Treatment

Experimental

half of the study subjects will receive the prescribed ventilatory support during open heart surgery.

干预措施: continuous, mechanical ventilatory support (Procedure)

结局指标

主要结局

Post-surgical lung function, compliance, tissue oxygenation, and radiographic changes indicative of atelectasis.

时间窗: During in-patient stay

Determination if ventilation during surgery improves post-surgical lung function, compliance, tissue oxygenation, and radiographic changes indicative of atelectasis.

次要结局

未报告次要终点

研究者

发起方
Aurora BayCare Medical Center
申办方类型
Other
责任方
Principal Investigator
主要研究者

Raul Mendoza-Ayala

Pulmonologist

Aurora BayCare Medical Center

研究点 (2)

Loading locations...

相似试验