跳至主要内容
临床试验/NCT02782871
NCT02782871撤回不适用

A Randomised Control Trial to Compare the Pneupac VR1 Portable Ventilator and Manual Ven-tilation Via a Mapleson C- Circuit During the Intra-hospital Transfers of Intubated Patients

Brighton and Sussex University Hospitals NHS Trust0 个研究点开始时间: 2016年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
主要终点
Pre- and post transfer partial pressure carbon dioxide measurements, from blood samples, taken from in-situ arterial line

研究概览

简要总结

Following major head and neck surgery it may be necessary to keep patients intubated and ventilated for at least 12 hours to allow the swelling associated with the operation to subside. Therefore patients (participants) are transferred to the intensive care unit anaesthetised, in-tubated and ventilated. Current practice is that patients are manually ventilated, by hand, during transfer from the operating theatre to the intensive care unit.

详细描述

Following major head and neck surgery it may be necessary to keep patients intubated and ventilated for at least 12 hours to allow the swelling associated with the operation to subside. Therefore patients (participants) are transferred to the intensive care unit anaesthetised, in-tubated and ventilated. Current practice is that patients are manually ventilated, by hand, during transfer from the operating theatre to the intensive care unit.

Studies show that use of manual ventilation causes variability in respiratory parameters and blood gas values due to inconsistent ventilation. A study in 2003 found that portable ventila-tor provided more consistent ventilation and patients were less likely to have a disparity in their blood gases, oxygenation and ventilation.. However, conventional ventilators are bulky, heavy, expensive and few and far between in the hospital and, in particular, the pre-hospital setting. The Pneupac VR1 ventilator is simple to use, small, portable and durable. It is easy to clean, low cost, light weight and magnetic resonance imaging (MRI) compatible.

The study will aim to directly compare the efficiency and efficacy (ventilation rate and tidal volumes) of manual ventilation against a new device, VR-1 portable ventilator, by Smith-Medical. The device is CE approved. The RCT will compare the efficacy and efficiency during transfer of the patient from theaters to intensive care in our establishment. The endpoint will be arrival to the intensive care unit (ICU) and transfer onto the ICU ventilator. This will be measured by collecting the pCO2, taken from an already in-situ arterial blood gas (ABG), at two time points - (a) just before patient transfer from theaters to the intensive care unit and (b) upon arrival at the intensive care unit and just prior to transfer onto the ITU ventilator.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Participant is willing and able to give informed consent for participation in the study.
  • Male or Female, aged 18 years or above.
  • Elective surgery
  • Undergoing Head and neck surgery, where routine care includes intubation, arterial line and post-operative transfer to intensive care unit intubated .
  • Able (in the Investigators opinion) and willing to comply with all study requirements.
  • Willing to allow his or her General Practitioner and consultant, if appropriate, to be notified of participation in the study.

排除标准

  • The participant may not enter the study if ANY of the following apply:
  • Have refused consent to participate in trial
  • Emergency surgery
  • Those patients who do not require intubation, arterial line and/ or transfer to intensive care intubated as routine practice for type of surgery/ procedure being undertaken

结局指标

主要结局

Pre- and post transfer partial pressure carbon dioxide measurements, from blood samples, taken from in-situ arterial line

时间窗: Average (mean) 10 minutes

The difference in pCO2 between patients in the control and the intervention group.

次要结局

未报告次要终点

研究者

发起方
Brighton and Sussex University Hospitals NHS Trust
申办方类型
Other
责任方
Sponsor

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