跳至主要内容
临床试验/NCT04755478
NCT04755478Unknown不适用

Ultrasound Assessment of Aeration Changes After Lung Lobectomy: a Pilot Study

Hospital General Universitario de Valencia1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2021年1月28日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
30
试验地点
1
主要终点
Change in mLUSS after lung resection.

研究概览

简要总结

The purpose of the study is to assess whether lung ultrasound is able to detect lung injury after lung resection surgery.

详细描述

Postoperative pulmonary complications (PPC) are common after lung resection surgery, with an incidence that ranges between 11-32%. As PPC are associated with worse outcomes, many studies aim to find predictors that identify high risk patients and prompt specific interventions and/or monitoring and hence, improve outcomes. PPC result from lung injury inherent to lung resection surgery. Lung aeration changes seen with lung ultrasound (LUS) could detect lung injury and thus, identify patients at high risk of PPC. The underlying mechanisms of lung injury are different in the dependent and non-dependent lung; oxidative stress in both lungs, lung injury associated with one-lung ventilation in the dependent lung and ischemia/reperfusion or surgical manipulation in the non-dependent lung. LUS evaluates the dependent and non-dependent lung separately and so it can be valuable in understanding the characteristics and intensity of lung injury in each lung specifically.

This is a prospective, single-centre, observational study in which 30 consecutive participants with non-small cell lung cancer scheduled for lobectomy will be recruited. Participants will be divided in two groups depending on the surgical approach. First group will be lobectomy via thoracotomy. Second group will be lobectomy via VATS. Participants will be recruited consecutively until there are 15 patients in each group. LUS will be performed in each participant's operated and non-operated lung at three predefined time points: before surgery, after extubation and 24 h after surgery. Each hemithorax will be divided into 6 areas: anterior, lateral and posterior, separated by the anterior and posterior axillary lines, each divided into upper and lower zones. For each echographic examination, cineloops of the most pathological findings in each area will be stored and analysed offline by two independent and blinded anaesthesiologists. From these, a semiquantitative score, the modified lung ultrasound score (mLUSS), will be calculated for each hemithorax to assess lung aeration at each time point. The level of agreement for mLUSS will be tested. At the same predefined time points blood plasma samples will be collected, flash-frozen and stored in order to measure levels of the inflammatory mediators IL-6, IL-10 and TNFα.

The investigators hypothesise that LUS can detect lung injury after lung resection surgery. The primary objective of the study is to assess changes in lung aeration after lung resection with mLUSS. Secondary objectives are, first, to describe LUS findings after lung resection surgery, second, to assess the ability of mLUSS to detect oxygenation changes after lung resection and third, to compare the behaviour of inflammatory mediators in plasma with mLUSS changes.

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

  • Age > 18
  • ASA I-III
  • Non-small cell lung neoplasm
  • Elective lung lobectomy
  • Under one-lung ventilation

排除标准

  • Pregnancy
  • Respiratory tract infection the previous month
  • Diagnosed pulmonary fibrosis
  • Predicted FEV < 40%
  • Surgery that includes resection of the thoracic wall or the diaphragm
  • Neoplasm metastasis
  • Obesity class II or more (BMI ≥ 35 kg/m^2)
  • Risk of malnutrition CONUT > 1
  • Hemoglobin < 10 g/dl
  • Chronic kidney failure: glomerular filtration < 60 ml/min/m^2, nephrectomy, kidney transplantation
  • Treatment with corticosteroids or immunosuppressive agents 3 months before surgery
  • Transfusion of blood products during the previous 10 days
  • Heart failure (New York Heart Association Functional Class 3 or 4) during the week before surgery.
  • Heart valve diseases over stage B of the American College of Cardiology/American
  • Heart Association Task Force on Practice Guidelines 2014
  • Diastolic dysfunction

结局指标

主要结局

Change in mLUSS after lung resection.

时间窗: preoperative vs immediate postoperative period vs 24 hours after surgery.

The modified lung ultrasound score (mLUSS) ranges 0-36; the higher the score, the less aeration (worse).

次要结局

  • Changes in plasma cytokine IL-10 after lung resection.(Preoperative vs immediate postoperative vs 24 hours after surgery.)
  • Changes in blood bone natriuretic peptide (BNP) after lung resection.(Preoperative vs immediate postoperative vs 24 hours after surgery.)
  • Changes in plasma TNFα after lung resection.(Preoperative vs immediate postoperative vs 24 hours after surgery.)
  • Changes in oxygenation (PAFI) after lung resection.(Preoperative vs immediate postoperative vs 24 hours after surgery.)
  • LUS feasibility in the dependent and non-dependent lung.(Preoperative vs immediate postoperative period vs 24 hours after surgery.)
  • Changes in plasma cytokine IL-6 after lung resection.(Preoperative vs immediate postoperative vs 24 hours after surgery.)

研究者

发起方
Hospital General Universitario de Valencia
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ana Broseta Lleó

Principal Investigator

Hospital General Universitario de Valencia

研究点 (1)

Loading locations...

相似试验