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临床试验/NCT02714556
NCT02714556撤回不适用

Changes in Ventilation Inhomogeneity and Respiratory Function Following Elective Caesarean Section Under Regional Anaesthesia: a Prospective Observational Study

Walid HABRE1 个研究点 分布在 1 个国家开始时间: 2016年5月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
发起方
试验地点
1
主要终点
Perioperative changes in ventilation inhomogeneity (LCI) following delivery by caesarean section

研究概览

简要总结

Pregnancy is associated with physiological changes affecting the cardiorespiratory system as a consequence of an increase in both cardiac output and intra-abdominal pressure. The aim of this prospective observational study is to examine the perioperative changes in ventilation inhomogeneity and respiratory function measured by the non-invasive nitrogen multiple breath washout and forced oscillation techniques.

详细描述

Pregnancy is associated with physiological changes affecting the cardiorespiratory system as a consequence of an increase in both cardiac output and intra-abdominal pressure. These alterations lead to a ventilation/perfusion mismatch which is potentiated by a decrease in functional residual capacity (FRC). These effects explain why pregnant women are more prone to the occurrence of hypoxemia, particularly in the third trimester of their pregnancy. The importance of the ventilation inhomogeneity can be estimated from the lung clearance index (LCI) measured by the non-invasive nitrogen multiple breath washout (N2 MBW) technique. Moreover the loss in lung volume is associated with reduction in respiratory system compliance, which can also be assessed non-invasively by the forced oscillation technique (FOT).

To our knowledge, there is no existing data on LCI or FRC using the aforementioned techniques in pregnant women. Furthermore, existing data on respiratory function in pregnant women is largely restricted to spirometric and body plethysmographic measurements taken primarily in the 1970s-1980s. As such, the important roles of lung ventilation inhomogeneity as well as the potential changes following birth after caesarean section have yet to be completely characterised.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Written informed consent
  • Pregnant woman in the third trimester (37-40 weeks gestational age)
  • Scheduled for elective caesarean section under regional (spinal or combined spinal-epidural) anaesthesia

排除标准

  • Pregnant women outside 37-40 weeks gestational age
  • Non-singleton pregnancy
  • Previous history of ≥2 caesarean sections
  • History or clinical signs of cardiopulmonary disease in the last 12 months (chronic hypertension, gestational hypertension, preeclampsia, asthma, acute or chronic bronchitis, others)
  • Positive current smoking status
  • Pre-pregnant body mass index (BMI) >30 kg/m2 (based on booking records)
  • Respiratory infection <2 weeks prior to surgery
  • Inability to perform the respiratory function tests

结局指标

主要结局

Perioperative changes in ventilation inhomogeneity (LCI) following delivery by caesarean section

时间窗: 1-3 days prior to caesarean section until 5 days postoperative

Nitrogen multiple breath washout technique

次要结局

  • Alterations in FRC throughout the postpartum period(1-3 days prior to caesarean section until 5 days postoperative)
  • Changes in respiratory mechanics: airway resistance (Raw)(1-3 days prior to caesarean section until 5 days postoperatively)
  • Perioperative respiratory complications(During caesarean section until 5 days postoperatively)
  • Changes in respiratory mechanics: respiratory system compliance (Crs)(1-3 days prior to caesarean section until 5 days postoperatively)
  • Perioperative respiratory interventions(During caesarean section until 5 days postoperatively)

研究者

发起方
Walid HABRE
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Walid HABRE

Professor

University Hospital, Geneva

研究点 (1)

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