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临床试验/NCT07063277
NCT07063277已完成不适用

Comparison of the Diagnostic Value of the Oxygen Reserve Index (ORI) and Spirometry Tests in Predicting Postoperative Respiratory Complications in Patients Undergoing Coronary Artery Bypass Surgery

Ankara Bilkent Sehir Hastanesi1 个研究点 分布在 1 个国家目标入组 142 人开始时间: 2025年7月5日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
142
试验地点
1
主要终点
Incidence of Postoperative Respiratory Complications

研究概览

简要总结

Coronary artery disease (CAD) is one of the most common cardiac conditions, primarily caused by atherosclerosis. Studies have shown that environmental factors such as lifestyle, diet, genetics, and air pollution contribute to the increasing prevalence of atherosclerosis. Despite advances in non-invasive and medical therapies, coronary artery bypass grafting (CABG) remains a definitive treatment in many cases. CABG is commonly performed using cardiopulmonary bypass (CPB), which increases the risk of additional complications. Among postoperative complications, pulmonary events are the most frequent and are closely associated with increased morbidity and mortality.

Postoperative pulmonary complications (PPCs) significantly raise healthcare costs, prolong hospital stays, and worsen patient outcomes. Cardiac surgery increases susceptibility to PPCs through factors such as sternotomy, CPB, myocardial protection via hypothermia, and phrenic nerve injury. These factors impair thoracic compliance, diaphragm movement, and mucociliary function. Mechanical ventilation further contributes through inflammatory responses that may cause barotrauma and volutrauma.

The incidence of PPCs varies from 1.96% to 43.7%, depending on patient characteristics, surgical type, and diagnostic criteria. With an aging population and more high-risk patients undergoing surgery, the incidence of PPCs is expected to rise. Reported preoperative risk factors include advanced age, active or recent smoking, BMI >25, heart failure, prior myocardial infarction, chronic lung disease, type 2 diabetes mellitus, hypertension, and ASA score >2. Intraoperative factors include prolonged anesthesia, CPB duration >95 minutes, multiple grafts, and use of the internal mammary artery. Postoperative contributors include prolonged ventilation, nasogastric tube use, and insufficient nursing care.

Common PPCs include atelectasis, pneumonia, bronchospasm, pulmonary embolism, pleural effusion, acute respiratory distress syndrome (ARDS), pneumothorax, hemothorax, and transfusion-related acute lung injury (TRALI). Atelectasis is observed in 30-72% of cases on postoperative chest X-rays. TRALI is the leading cause of transfusion-related death and is characterized by hypoxia and bilateral pulmonary infiltrates. Pleural effusions are associated with low BMI, female sex, atrial fibrillation, heart failure, valve surgery, and anticoagulant use. Phrenic nerve injury, often resulting from internal thoracic artery dissection or cold-induced damage during myocardial protection, leads to unilateral diaphragmatic dysfunction.

Hospital-acquired infections, particularly pneumonia, are among the most common and costly non-cardiac complications following cardiac surgery. Pneumonia occurs in 2.4%-20% of cases, while ventilator-associated pneumonia affects 35.2% of patients intubated longer than 48 hours. ARDS is the most severe PPC, involving widespread alveolar injury, endothelial disruption, and non-cardiogenic pulmonary edema. Tension pneumothorax may also occur after chest tube removal.

Spirometry is a standard preoperative test used to assess lung function, primarily through FEV₁ and FVC values. These measurements help detect obstructive or restrictive defects. FEV₁/FVC <70% has been identified as an independent risk factor for PPCs. However, spirometry's predictive value is limited. A systematic review by Dankert et al. reported sensitivities ranging from 38% to 84% and specificities from 55% to 99%. Combined data yielded a sensitivity of 62%, specificity of 70%, and an area under the curve (AUC) of 0.74.

Pulse oximetry alone cannot reliably indicate PaO₂ above 100 mmHg or provide information on oxygen reserve. The Oxygen Reserve Index (ORI) is a novel, continuous, and non-invasive parameter that evaluates oxygenation status in the mild hyperoxic range (PaO₂ 100-200 mmHg). ORI values range from 0.00 to 1.00 and correlate with changes in PaO₂. ORI >0.24 corresponds to PaO₂ ≥100 mmHg when SpO₂ exceeds 98%, while ORI >0.55 may indicate PaO₂ ≥150 mmHg. A declining ORI trend approaching 0.24, despite SpO₂ >98%, can signal impending hypoxemia.

Given the substantial impact of PPCs on postoperative outcomes and the limitations of spirometry in accurately predicting these complications, there is a need for more reliable preoperative assessment tools. The present study aims to compare the diagnostic performance of the Oxygen Reserve Index and spirometry in predicting postoperative respiratory complications in patients undergoing coronary artery bypass surgery. The goal is to identify a more accurate and effective method for preoperative pulmonary risk stratification.

详细描述

Coronary artery disease (CAD) is one of the most prevalent cardiac disorders caused by atherosclerosis. Comprehensive studies have shown that changes in environmental factors such as lifestyle, diet, genetics, and air pollution contribute to an increased incidence of atherosclerosis. Despite the continuous development of non-invasive and medical treatments, coronary artery bypass grafting (CABG) remains the final treatment option for many patients. In this procedure, open-heart surgery is performed with or without the use of cardiopulmonary bypass (CPB), during which vascular grafts are created. In most cases, CPB is utilized, which may lead to additional complications beyond those associated with the surgery itself. Following CABG, cardiovascular, pulmonary, renal, infectious, and psychiatric complications may occur. Among these, pulmonary complications are the most commonly encountered and are significantly associated with morbidity and mortality.

Postoperative pulmonary complications (PPCs) following cardiac surgery increase healthcare costs, prolong hospital stay, and elevate morbidity and mortality rates. Cardiac surgery predisposes to PPCs more than other surgical types due to median sternotomy/thoracotomy, CPB, myocardial protection via hypothermia, and phrenic nerve injury. It directly impairs thoracic compliance, diaphragm function, and mucociliary clearance. Additionally, mechanical ventilation activates local and systemic inflammatory responses, leading to volutrauma and barotrauma.

The incidence of PPCs following cardiac surgery ranges from 1.96% to 43.7%, depending on patient-related risk factors, the type of cardiac procedure performed, and the definition of PPC used. With the increasing number of high-risk patients undergoing cardiac surgery due to an aging population, a rise in PPC incidence is expected. Preoperative risk factors identified in various studies include age above 65 or 80 years, active smoking within the past 6 or 12 months, body mass index over 25, heart failure, history of myocardial infarction (MI), chronic lung disease, type 2 diabetes mellitus (DM2), hypertension (HT), and an American Society of Anesthesiologists (ASA) score greater than 2. Intraoperative risk factors include anesthesia duration longer than 270 minutes, CPB duration longer than 95 minutes, repair of four or more vessels, and use of the internal mammary artery (IMA) as a graft. Postoperative risk factors include mechanical ventilation for more than 10 hours, presence of a nasogastric tube, and lack of high-quality nursing care.

PPCs include atelectasis, pneumonia, bronchospasm, pulmonary embolism, pleural effusion, acute respiratory distress syndrome (ARDS), pneumothorax, hemothorax, mechanical ventilation longer than 48 hours, transfusion-related acute lung injury (TRALI), and phrenic nerve injury. Atelectasis is a common cause of hypoxemia and impaired gas exchange following cardiac surgery. Postoperative chest X-rays show atelectasis in 30-72% of patients, making it one of the leading causes of respiratory dysfunction. TRALI is the most common transfusion-related adverse event and the leading cause of transfusion-related deaths globally. It is characterized by acute hypoxia and bilateral pulmonary infiltrates following allogeneic blood transfusion. Pleural effusions after CABG are associated with low body mass index, female sex, history of atrial fibrillation, heart failure, concomitant valve surgery, and anticoagulant use. Surgical injury to the phrenic nerve often results in unilateral loss of diaphragmatic function and is commonly observed during dissection of the internal thoracic artery. Previous studies have shown that phrenic nerve injury may also occur due to cold exposure during myocardial protection strategies.

Healthcare-associated infections are a leading cause of non-cardiac morbidity after cardiac surgery. Among these, pneumonia is the most frequently observed, the most expensive, and the most resource-intensive infection. Pneumonia develops in 2.4% to 20% of patients following cardiac surgery. Additionally, ventilator-associated pneumonia occurs in 35.2% of patients who remain on mechanical ventilation for more than 48 hours. ARDS is the most severe pulmonary complication after cardiac surgery, characterized by pro-inflammatory injury to the alveolar structure, widespread endothelial damage, severe hypoxia, and non-cardiogenic pulmonary edema.

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
否

入选标准

  • •Undergoing elective coronary artery bypass grafting (CABG) surgery.
  • •Aged 18 years or older at the time of enrollment.
  • •Provided written informed consent to participate in the study.
  • •Medically stable and cooperative for preoperative respiratory assessments (ORI and spirometry).

排除标准

  • •Refusal to participate or failure to provide informed consent.
  • •Age under 18 years.
  • •Left ventricular ejection fraction below 40% on preoperative evaluation.
  • •Presence of cognitive impairment or psychiatric disorders preventing cooperation (e.g., dementia, Alzheimer's disease).
  • •Severe anemia defined as hemoglobin level below 8 g/dL.
  • •Undergoing emergency surgery rather than elective CABG.
  • •Anatomical or mechanical obstruction that may impair nasal oxygenation (e.g., severe nasal septum deviation, presence of a nasogastric tube).

研究组 & 干预措施

Preoperative Evaluation with ORI and Spirometry

Experimental

All participants in this arm will undergo preoperative evaluation using two non-invasive methods: the Oxygen Reserve Index (ORI) and spirometry. ORI will be measured via a fingertip pulse co-oximetry sensor, reflecting oxygen reserve within the PaO₂ range of 100-200 mmHg. Measurements will be taken during routine preoxygenation with room air and supplemental oxygen. Spirometry will be conducted according to standard pulmonary function testing protocols and will include FEV₁, FVC, and FEV₁/FVC ratio. The aim is to assess and compare the predictive value of ORI and spirometry for identifying postoperative respiratory complications in patients undergoing coronary artery bypass grafting (CABG). No therapeutic intervention will be applied.

干预措施: Preoperative Evaluation with ORI and Spirometry (Device)

结局指标

主要结局

Incidence of Postoperative Respiratory Complications

时间窗: Postoperative 48 hours

Postoperative respiratory complications, including but not limited to collapse of part or all of a lung (atelectasis), lung infection (pneumonia), the need for continued use of a breathing machine for an extended period after surgery (prolonged mechanical ventilation), or abnormalities in oxygen levels in the blood (oxygenation disorders), will be systematically assessed during the first 48 hours following the surgical procedure. Each event will be evaluated based on clinical symptoms such as shortness of breath, abnormal breath sounds, or decreased oxygen saturation. Additional confirmation will be obtained through diagnostic tools including chest imaging (such as chest X-ray), arterial blood gas analysis, and ventilator parameters. The presence, timing, and severity of each complication will be documented, as well as any medical or mechanical respiratory support required (such as supplemental oxygen, non-invasive ventilation, or reintubation)

次要结局

  • Intraoperative Hemodynamic or Surgical Complications(During surgery)
  • Preoperative Peak ORI Value(Preoperative period (within 24 hours prior to surgery))
  • FEV₁ (Forced Expiratory Volume in 1 second)(Preoperative period (within 24 hours prior to surgery))
  • Intraoperative Respiratory Complications(During surgery)
  • In-Hospital Postoperative Mortality(From the date of surgery until hospital discharge, assessed up to 180 days)
  • FVC (Forced Vital Capacity)(Preoperative period (within 24 hours prior to surgery))
  • PEF (Peak Expiratory Flow)(Preoperative period (within 24 hours prior to surgery))
  • Duration of Intensive Care Unit and Total Hospital Stay(From the date of surgery until ICU and hospital discharge, assessed up to 180 days)

研究者

发起方
Ankara Bilkent Sehir Hastanesi
申办方类型
Other
责任方
Principal Investigator
主要研究者

Muhammed Talha Daşgın

Anesthesiology and Reanimation Doctor, Principal Investigator

Ankara Bilkent Sehir Hastanesi

研究点 (1)

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