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临床试验/NCT04760340
NCT04760340Unknown不适用

TELUS in Cardiac Surgery Patients. Effect of CPB and Relation to Postoperative Events (PORE).

Clinique du Millenaire0 个研究点目标入组 120 人开始时间: 2021年3月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
120
主要终点
Extubation time (minutes)

研究概览

简要总结

Transesophageal Lung ultrasound (TELUS) was described for the first time in 2016. The clinical significance and benefits for the patient of the results of a TELUS examination has not been investigated to date.

Since all cardiac surgery with CPB cases in adult patients are performed using a TEE probe to monitor cardiac function, a concomitant TELUS examination is possible in all cases.

The study seeks to describe the incidence and severity of the modifications of the aeration of both lungs assessed by TELUS in the perioperative period of adult cardiac surgery and to establish the relation of the TELUS findings with the occurence of postoperative respiratory events (PORE).

Eventually, the study will also provide results about the interobserver variation of the TELUS examination for which there no reference to date.

详细描述

Trans Esophageal Lung Ultrasound (TELUS) score in Cardiac surgery (CS) patients.

Effect of CPB and relationship between changes on TELUS score and postoperative respiratory events (PORE).

International recommendations for LUS assessment are available as well as the LUS methodology and nomenclature are widely accepted (1). Additionally, transthoracic LUS demonstrated a predictive value for postoperative pulmonary complication in non-cardiac surgery (2).

More recently, the Trans Esophageal Lung Ultrasound (TELUS) has been described (3).

Adult cardiac surgery patients are at special risk of perioperative respiratory complications including pulmonary edema, Acute Respiratory Distress Syndrome (ARDS), prolonged ventilation and non-invasive ventilation (NIV), tracheotomy and pulmonary infection (4). These complications are responsible for a substantial part of the perioperative case fatality rate. Prevention of these complications by using low tidal volume and an open lung strategy has failed to significantly reduce the incidence of postoperative respiratory events (PORE) (5).

研究设计

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

入排标准

性别
All
接受健康志愿者

入选标准

  • * Adult cardiac surgery patients with a comprehensive TEE and TELUS examination pre CPB will be included.

排除标准

  • Previous lung surgery
  • Previous thoracic radiation therapy for cancer (lung, breast, lymphoma or other)
  • Mitral valve surgery using a mini thoracotomy and video assistance
  • Use of an ultrafiltration device during CPB
  • Mechanical ventilation initiated before arrival in the OR.

结局指标

主要结局

Extubation time (minutes)

时间窗: 150 days

Time from ICU admission to first postoperative successful extubation.

Total ICU stay (hours)

时间窗: 150 days

Length of stay in the icu during hospital stay

Total postoperative NIV time (hours)

时间窗: 150 days

Total time on NIV during postoperative hospital stay

Total MV time (hours)

时间窗: 150 days

Total time on MV during postoperative hospital stay

次要结局

  • Post CPB TELUS score (n)(1 day)
  • Post CPB P/F ratio (mmHg)(1 day)
  • Pre CPB TELUS score (n)(1 day)

研究者

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

Philippe BURTIN

Head of Anesthesiology Department

Clinique du Millenaire

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