Prediction of Perioperative Complication Risk Using Chronic Obstructive Pulmonary Disease Assessment Test Score in Chronic Obstructive Pulmonary Disease Patients: A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Incidence of Postoperative Respiratory Complications Within 72 Hours
研究概览
简要总结
The goal of this observational cohort study is to evaluate whether the COPD Assessment Test (CAT) score can predict the risk of perioperative respiratory complications in patients aged 40 to 70 years with diagnosed Chronic Obstructive Pulmonary Disease (COPD), undergoing elective surgical procedures lasting no longer than 150 minutes.
The main questions it aims to answer are:
- Is there a statistically significant association between preoperative CAT scores and the incidence of intraoperative and early postoperative respiratory complications in COPD patients?
- Can the CAT score be effectively used as a preoperative risk stratification tool to guide anesthetic and surgical decision-making?
Researchers will compare two patient groups based on CAT scores: those with CAT <10 and those with CAT ≥10 to determine whether higher CAT scores are associated with an increased incidence of perioperative respiratory complications.
Participants will:
- Complete the CAT questionnaire during the preoperative evaluation
- Undergo elective surgery with an expected duration of ≤150 minutes
- Be monitored intraoperatively for bronchospasm, oxygen desaturation, and ventilation difficulty
- Be monitored postoperatively (within the first 72 hours) for hypoxemia, reintubation, bronchospasm episodes, postoperative pneumonia, intensive care unit (ICU) admission, and length of hospital stay
- Have perioperative clinical data collected and analyzed for comparative outcomes between CAT score subgroups
详细描述
Chronic Obstructive Pulmonary Disease (COPD) is a common chronic respiratory disease associated with increased perioperative morbidity and mortality. Surgical procedures in COPD patients often carry higher risks of respiratory complications, making anesthetic management more challenging. The COPD Assessment Test (CAT) is a simple and practical tool developed to assess symptom burden in COPD patients and is being increasingly integrated into clinical practice. While its utility in evaluating disease-related symptoms and quality of life is well documented, the role of CAT score in predicting perioperative respiratory complications remains unclear.
This prospective observational cohort study aims to evaluate whether the CAT score can be used to predict perioperative respiratory risk and support clinical decision-making for anesthesiology and surgical teams. Based on previous estimates, patients with high CAT scores appear to be at greater risk for complications. A total of 120 patients will be enrolled in the study, with 60 patients in each group. Patients will be categorized into two groups based on their CAT scores:
Group 1: CAT <10 (Low symptom burden)
Group 2: CAT ≥10 (High symptom burden)
Patients aged 40-70 years with a diagnosis of stable COPD scheduled for elective surgery lasting no more than 150 minutes will be included. The relationship between CAT score and perioperative respiratory complications will be statistically analyzed.
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
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged between 40 and 70 years
- •Diagnosed with stable-stage Chronic Obstructive Pulmonary Disease (COPD) according to GOLD criteria
- •Scheduled for elective surgical intervention
- •Classified as ASA Physical Status II or III according to the American Society of Anesthesiologists (ASA)
- •Planned for postoperative follow-up and eligible for at least 72 hours of observation
- •Undergoing surgery with an expected duration of at least 150 minutes
- •Willing to participate voluntarily in the study
排除标准
- •Patients younger than 40 years or older than 70 years
- •History of COPD exacerbation within the past 4 weeks
- •Presence of severe cardiac failure (EF <30%), end-stage renal disease, or active malignancy
- •Neurological disorders or cognitive impairments
- •Requirement for invasive mechanical ventilation in the preoperative period
- •Altered consciousness or any condition preventing completion of forms before anesthesia
- •Undergoing surgery with an expected duration longer than 150 minutes
- •Unwillingness to participate in the study voluntarily
研究组 & 干预措施
CAT <10 (Low symptom burden)
Patients scheduled for elective surgery, diagnosed with COPD in a stable stage according to the GOLD (Global Initiative for Chronic Obstructive Lung Disease) criteria, and identified as having a low symptom burden (CAT <10) based on preoperative CAT scoring
干预措施: Arterial Blood Gas Analysis (Other)
CAT ≥10 (High symptom burden)
Patients scheduled for elective surgery, diagnosed with COPD in a stable stage according to the GOLD (Global Initiative for Chronic Obstructive Lung Disease) criteria, and identified as having a high symptom burden (CAT ≥10) based on preoperative CAT scoring
干预措施: Arterial Blood Gas Analysis (Other)
结局指标
主要结局
Incidence of Postoperative Respiratory Complications Within 72 Hours
时间窗: Within 72 hours postoperatively
Respiratory complications including hypoxemia (SpO₂ \< 90%), reintubation, bronchospasm, pneumonia, or ICU admission will be recorded during the first 72 hours after surgery. Each event will be assessed based on standardized clinical definitions. The outcome will be reported as the number of patients who experience at least one of the defined complications.
次要结局
- Maximum Oxygen Flow Rate Administered Postoperatively(Within 72 hours postoperatively)
- Initiation of Postoperative Oxygen Therapy(Within 72 hours postoperatively)
- Duration of Postoperative Oxygen Therapy(Within 72 hours postoperatively)
研究者
Mehmet Sercan Orbak
Anesthesiology Specialist (MD)
Erzurum City Hospital