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临床试验/NCT03467607
NCT03467607已完成不适用

A Feasibility Study of a Low Tidal Volume Ventilation Strategy in One Lung Ventilation

University of Dublin, Trinity College1 个研究点 分布在 1 个国家目标入组 45 人开始时间: 2016年10月20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
45
试验地点
1
主要终点
Radiological evidence of injury to the ventilated lung

研究概览

简要总结

A study of two ventilatory strategies for low tidal volume ventilation compared to a control group to elucidate if low tidal volumes of 3ml/kg or 4ml/kg were feasible for one lung ventilation.

详细描述

This study investigated the feasibility of low tidal volume ventilation for one lung ventilation.

45 patients were recruited - 15 patients in each of three groups, 3ml/kg, 4ml/kg or usual care.

Outcomes studied were length of stay, 30 day mortality, unplanned ICU admission, evidence of respiratory failure or requirement for non-invasive ventilation, chest x-ray infiltrates and requirement for antibiotics.

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
None

盲法说明

open label, randomisation blinded

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

入选标准

  • ASA I-III lung resection surgery requiring one lung ventilation

排除标准

  • ASA IV or above under 18 or over 80 years of age pregnancy previous lung lobectomy or pneumonectomy requirement for massive transfusion during the case BMI > 35

研究组 & 干预措施

3ml/kg

Active Comparator

15 patients ventilated with 3ml/kg ideal body weight while on one lung ventilation

干预措施: tidal volume ventilation (Procedure)

4ml/kg

Active Comparator

15 patients ventilated with 4ml/kg ideal body weight while on one lung ventilation

干预措施: tidal volume ventilation (Procedure)

control

Active Comparator

15 patients ventilated using the anaesthetists usual ventilation strategy

干预措施: tidal volume ventilation (Procedure)

结局指标

主要结局

Radiological evidence of injury to the ventilated lung

时间窗: post operatively up to 6 weeks post operatively

evidence of infiltrates in the non operative lung

unplanned ICU admission

时间窗: up to 6 weeks post operatively

unplanned admission to the icu with respiratory issues

Requirement for non-invasive ventilation

时间窗: up to 6 weeks post operatively

whether a patient in the trial requires niv for respiratory failure

Hospital acquired pneumonia

时间窗: up to discharge at 6 weeks post operatively

pneumonia acquired in hospital

次要结局

  • length of hospital stay(until patient discharge at 6 weeks post operatively)
  • length of icu stay(until patient discharge at 6 weeks post operatively)
  • 30 day mortality(30 days post operatively)

研究者

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

ignacio martin loeches

Consultant Intensivist

University of Dublin, Trinity College

研究点 (1)

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