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临床试验/NCT05508724
NCT05508724已完成不适用

An Observational Study of the Relationship Between Pressure-volume Curves and Recruitability of the Lung in Mechanically Ventilated Critically Ill Patients With Respiratory Failure

University of Oxford1 个研究点 分布在 1 个国家目标入组 48 人开始时间: 2022年10月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
48
试验地点
1
主要终点
Functional residual capacity

研究概览

简要总结

Diseases of the lungs can be life-threatening. When these organs fail to adequately work, treatments to support their function are offered, often in Intensive Care Units (ICU). Respiratory failure patients may need sedation and placement of a tube in their windpipe so that a mechanical ventilator can take over their breathing until they have recovered enough to breathe again on their own. One problem that occurs in patients under mechanical ventilation is that parts of the lung tissue tend to collapse (atelectasis), reducing the amount of the lung that is able to transfer oxygen and carbon dioxide effectively and even progressing to pneumonia.

To address this problem, ICU doctors often perform a procedure named 'recruitment manoeuvre', which involves briefly inflating the patient's lungs with enough pressure to try to open up the collapsed areas of lung. However, fundamental aspects of the change in the functioning of the heart and lungs that occur during and after such manoeuvre are not fully understood.

In this study, funded by the University of Oxford, the investigators wish to study patients with respiratory failure who are receiving mechanical ventilation. Participants will be recruited at the ICU of the Royal Berkshire Hospital having their cardiopulmonary data collected over the course of a day. During this period, some patients will be assessed to determine whether they may benefit from a recruitment manoeuvre using a pressure-volume curve. As this assessment is not perfect, the investigators wish to study which features of this curve predict a successful recruitment. The investigators will do this by evaluating the volume of the lung before and after the recruitment manoeuvre is performed using a device named Optical Gas Analyser.

A better understanding of the effects of the recruitment manoeuvre will help the investigators to determine how and when such manoeuvres should be performed in critically ill patients.

详细描述

Critical care units provide supportive therapies to help patients survive a period of life-threatening illness. Among such treatments, mechanical ventilation constitutes an essential asset to assist in patient recovery from respiratory failure and to provide airway protection in neurologically compromised patients. The need for mechanical ventilation is more often driven by respiratory failure than a need for neuroprotection. In excess of 100,000 adult patients are mechanically ventilated in UK ICUs annually, and this number has risen considerably recently due to the emergence of the COVID-19 pandemic.

Respiratory failure may be triggered by pulmonary (e.g., pneumonia, acute respiratory distress syndrome, interstitial fibrosis) or extra-pulmonary (e.g., sepsis, shock) disturbances. The abnormal function of the cardiorespiratory system in these critical conditions results in carrying degrees of hypoxaemia and hypercapnia, leading to the need for respiratory support by mechanical ventilation.

In patients undergoing mechanical ventilation for respiratory failure, the lung is characterized by a much-enhanced tendency to collapse. This collapse worsens hypoxaemia, and increases the stress and strain applied to those regions of the lung that remain aerated, leading to ventilator-induced lung injury (VILI). Re-aeration of non-aerated lung (recruitment) improves oxygenation and prevents VILI. For this reason, some clinicians employ recruitment manoeuvres following intubation, or subsequently during their ICU stay. However, it remains unclear which patients benefit from this intervention, at what time point(s) it is most beneficial, and the underlying mechanisms.

It is recognised that the volume of lung that is potentially recruitable (recruitability) varies widely from patient to patient, being influenced by: (i) the underlying disease precipitating respiratory failure (pulmonary versus extrapulmonary injury); (ii) the distribution of lung injury (lobar versus non lobar); and (iii) the time from initiation of lung injury.

An ability to assess recruitability is a pre-requisite for a rational recruitment strategy and selecting parameters for mechanical ventilation. The gold standard to assess recruitability involves performing a CT scan at two different levels of inspiratory pressure and assessing the mass of lung tissue (grams) that transitions from a non-aerated to an aerated state. This is not feasible in everyday clinical practice since it is time consuming, requires transfer of a critically ill patient to the radiology suite, and involves a significant exposure to ionising radiation. An alternative is to use some measure of the change in lung volume between the different pressure levels, but this is not the same as a change in non-aerated lung mass and indeed the two measures may not even be correlated.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Cross Sectional

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

  • Male and female, aged 18 years or above
  • Receiving mechanical ventilation for respiratory failure via an endotracheal tube on ICU

排除标准

  • Consultee indicates patient would be likely to decline enrolment
  • Patient is receiving palliative care
  • Language barriers prevent sufficiently good communication with patient or consultee for full consent to be obtained

研究组 & 干预措施

Critically-ill mechanically ventilated patients

Intensive Care patients receiving mechanical ventilation due to respiratory failure

结局指标

主要结局

Functional residual capacity

时间窗: Changes from FRC baseline value measured immediately after PV curve determination and lung recruitment manoeuvre

To determine whether parameters derived from the airway pressure-volume curve predict changes in static measures of lung volume in response to recruitment manoeuvres

次要结局

  • Anatomic dead space(Changes from anatomic dead space baseline value measured immediately after PV curve determination and lung recruitment manoeuvre)
  • Ventilation inhomogeneity(Changes from ventilation inhomogeneity baseline value measured immediately after PV curve determination and lung recruitment manoeuvre)

研究者

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

Dr Jessica Souza Luiz

Research Fellow in Clinical Pulmonary Physiology

University of Oxford

研究点 (1)

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