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临床试验/NCT04276844
NCT04276844已完成不适用

Incidence of Postoperative Persistent Diaphragmatic Dysfunctions in Cardiac Surgery

CMC Ambroise Paré1 个研究点 分布在 1 个国家目标入组 157 人开始时间: 2020年3月4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
157
试验地点
1
主要终点
Incidence of persistent diaphragmatic dysfunctions after cardiac surgery

研究概览

简要总结

Postoperative respiratory complication is a common complication that occurs in 6% of patients after cardiac surgery and increases morbidity and mortality and hospital length of stay. Diaphragmatic dysfunction (DD) is one of the main risk factors for post-operative respiratory distress syndrome. It alters the ventilatory mechanical function of patients and promotes pneumonia. In the literature, risk factors included older age, diabetes, harvesting of a mammary artery, intraoperative ice solution using, prolonged cardiopulmonary bypass and intra-operative phrenic nerve injury.

Ultrasonography using the two-dimensional (2D) mode is a diagnosis tool for DD. For patients with DD, ultrasound criteria are: 1) an excursion during quiet breathing < 9 mm for woman and < 10 mm for man, 2) an excursion after sniff test < 16 mm for woman and < 18 mm for man and 3) an excursion during deep breathing < 37 mm for woman and < 47 mm for man. A paradoxical diaphragmatic ascent may also be observed during inspiration.

DD may be transient, linked to mechanical factors such as pain, the presence of pleural and mediastinal drains, lying down or sternotomy; with recovery from 5 postoperative days. It may be more prolonged (persistent after 7 days) in connection with a partial or complete phrenic nerve injury and / or diaphragmatic devascularization after mammary artery harvesting.

The aim of this prospective study is to determine the incidence of persistent DD after cardiac surgery.

详细描述

Diaphragmatic amplitude will be assessed by ultrasonography during quiet breathing and after sniff test, before the surgery and at day 7 post-surgery in all patients.

Patients with persistent DD at day 7 post-surgery will have additional Respiratory Functional Explorations.

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
All
接受健康志愿者

入选标准

  • Patients undergoing cardiac surgery requiring sternotomy
  • Consent for participation
  • Affiliation to the social security system

排除标准

  • Contraindication to preoperative respiratory functional explorations
  • Pregnant or breastfeeding women
  • Patients under protection of the adults (guardianship, curators or safeguard of justice)
  • Communication difficulties or neuropsychiatric disorder

结局指标

主要结局

Incidence of persistent diaphragmatic dysfunctions after cardiac surgery

时间窗: 8 days

Diaphragmatic excursion measured during sniff test (displacement, mm)

次要结局

  • Hospital length of stay(up to 2 months)
  • Incidence of respiratory complications(up to 2 months)
  • Respiratory function test in the group with persistent diaphragmatic dysfunction(8 days)
  • Intensive Care Unit (ICU) length of stay(up to 2 months)

研究者

发起方
CMC Ambroise Paré
申办方类型
Other
责任方
Sponsor

研究点 (1)

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