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临床试验/NCT04605250
NCT04605250已完成不适用

Respiratory Variability for Respiratory Monitoring During the Postoperative Recovery Period

University Hospital Center of Martinique2 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2019年5月21日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
50
试验地点
2
主要终点
Variation of the Tidal volume (Vt) between the preoperative and the postoperative period

研究概览

简要总结

The research consist of measuring respiratory variability of several variables of the respiratory pattern at rest and during exercise using a thoracic movement measuring technique. The objective is to confirm the ability of this technique to measure the respiratory variability in healthy subjects comparing to flow measurements by a pneumotachograph. In a second step, the thoracic movement technique is applied to measure respiratory variability before and after surgery in patients after abdominal surgery with laparotomy. The objective is to observe a decrease of variability in subjects developing or at risk to develop a postoperative pulmonary complication.

详细描述

The incidence of Postoperative Pulmonary Complications after non-thoracic surgery varie between 2 and 19%. Postoperative Pulmonary Complications are associated with an increase of morbi-mortality and longer hospital stays. However, few possibilities are available to identify Postoperative Pulmonary Complications except predictions scores and SpO2, which decreases only face to a significant lung disease. Besides, the respiratory variability decreases during pulmonary stress situations, and is associated with an increase of mortality during mechanical ventilation. The hypothesis is that a decrease of the respiratory variability between the preoperative and the postoperative measures is associated with an increase of Postoperative Pulmonary Complications . However there is no mesuring tool of easy access in clinical practice. That is why, in a first step, a thoracic sensor belt will be tested on healthy subjects. This sensor belt is available to measure the respiratory variability.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Other
盲法
None

入排标准

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

入选标准

  • Physiological step :
  • adults without any acute or chronic disease with a significant impact on daily life, particularly no cardio-respiratory disease.
  • Smokers can be included.
  • Free and informed consent signed.
  • Clinical step :
  • adults undergoing abdominal surgery with laparotomy, in emergency or scheduled,
  • in Martinique and Guadeloupe.
  • Free and informed oral consent.

排除标准

  • Pregnant,breast feeding women,
  • intubated patients or with criteria of imminent intubation
  • subject unable to give his free and informed consent

结局指标

主要结局

Variation of the Tidal volume (Vt) between the preoperative and the postoperative period

时间窗: 7 days

Measure the respiratory variability in patients with abdominal surgery with laparotomy just before the anaesthetic induction and in the postoperative stage after extubation with a belt equipped with an external sensor.

次要结局

未报告次要终点

研究者

发起方
University Hospital Center of Martinique
申办方类型
Other
责任方
Sponsor

研究点 (2)

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