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临床试验/NCT07262905
NCT07262905已完成不适用

Sedation Related Respiratory Deterioration in COPD: Risk Indicators and Predictive Performance of the Integrated Pulmonary Index

Umran Karaca1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年1月20日最近更新:

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
100
试验地点
1
主要终点
Association Between Respiratory Deterioration and COPD-Specific Clinical Risk Indicators

研究概览

简要总结

This prospective observational clinical study investigates two key questions in COPD patients undergoing sedated endoscopic procedures. The first is whether respiratory deterioration that may occur during the procedure is associated with clinical risk indicators such as symptom burden, prior exacerbations, and previous hospitalizations. The second is to assess the effectiveness of the Integrated Pulmonary Index (IPI) in predicting this deterioration, and to compare its performance with traditional respiratory monitoring parameters including oxygen saturation (SpO₂) and capnography (EtCO₂).

The study hypothesis is that respiratory deterioration is linked to clinical risk indicators and that the IPI will demonstrate superior predictive accuracy compared with classical monitoring parameters.

All participants will belong to a single COPD cohort and will not be assigned to different intervention arms. For analysis, patients will be categorized based on whether clinical interventions-such as increased oxygen flow, repositioning, or respiratory support-become necessary during the procedure. This classification reflects routine clinical care, and no additional interventions are performed as part of the study.

详细描述

Chronic obstructive pulmonary disease (COPD) is a progressive disorder characterized by persistent airflow limitation, with dyspnea and productive cough being the predominant clinical features. According to the GOLD 2024 guidelines, the one-year history of exacerbations, including both the number of exacerbations and associated hospitalizations, represents the strongest predictor of future risk in COPD. The A-B-E classification system, based on symptom severity (CAT score) and exacerbation history, provides a structured framework for defining the clinical risk level of COPD patients.

Sedation in individuals with COPD can lead to rapid deterioration of respiratory function due to markedly limited ventilatory reserve. In this high-risk population, hypoventilation, apnea, desaturation, or alterations in capnographic waveforms during sedation constitute key indicators of respiratory compromise. While conventional monitoring parameters such as SpO₂, EtCO₂, respiratory rate, and pulse rate evaluate specific components of respiratory physiology individually, the Integrated Pulmonary Index (IPI) consolidates these four parameters into a single composite score reflecting both oxygenation and ventilation status. This integrated approach may facilitate earlier and more reliable detection of respiratory deterioration.

This prospective observational study focuses on two primary questions. First, it aims to investigate the relationship between respiratory deterioration occurring during sedated procedures and clinical risk indicators such as symptom severity (CAT score), the number of exacerbations in the previous year, and associated hospital admissions. Second, it seeks to evaluate the predictive performance of the IPI for identifying such respiratory deterioration and to compare its accuracy with classical respiratory monitoring parameters, namely SpO₂ and EtCO₂. This comparison will help determine whether the IPI provides an additional early-warning advantage for COPD patients undergoing sedation.

All participants will be included in a single COPD cohort, and the study involves no randomization or intervention arms. During data analysis, patients will be classified according to whether clinical interventions, such as increased oxygen supplementation, repositioning, or respiratory support, become necessary during the procedure. This classification reflects routine clinical decision-making and does not represent an intervention introduced by the study protocol.

The study hypothesizes that respiratory deterioration during sedation is associated with established clinical risk indicators and that the IPI will demonstrate higher predictive accuracy than conventional respiratory monitoring parameters.

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 years
  • Diagnosed with Chronic Obstructive Pulmonary Disease (COPD) according to GOLD 2024 criteria
  • Classified as ASA physical status I-IV
  • Undergoing elective gastrointestinal endoscopic procedure under sedation analgesia
  • Suitable for sedation outside the operating room
  • Provided written informed consent -

排除标准

  • Age < 18 years
  • Unstable cardiovascular or respiratory condition
  • Requirement for general anesthesia or advanced airway management
  • Known hypersensitivity to sedative medications
  • Refusal or inability to provide informed consent

结局指标

主要结局

Association Between Respiratory Deterioration and COPD-Specific Clinical Risk Indicators

时间窗: 0, 3, 5, 10, 15, and 20 minutes during the procedure.

Respiratory deterioration (yes/no) requiring clinical intervention during sedated combined gastroscopy-colonoscopy will be assessed for its association with baseline COPD-specific risk indicators, including the COPD Assessment Test (CAT) score, one-year exacerbation frequency, and COPD-related hospitalizations.

次要结局

  • Diagnostic Performance of the Integrated Pulmonary Index (IPI) for Predicting Respiratory Deterioration(0, 3, 5, 10, 15, and 20 minutes during the procedure.)

研究者

发起方
Umran Karaca
申办方类型
Other Gov
责任方
Sponsor Investigator
主要研究者

Umran Karaca

Assoc. Prof. of Anesthesiology and Reanimation

Bursa Yuksek Ihtisas Training and Research Hospital

研究点 (1)

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