Bursa Yüksek İhtisas Training and Research Hospital
Bursa, Marmara Region, 16310, Turkey (Türkiye)
NCT Number: NCT07262905
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.
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All sexes
Observational
Bursa, Marmara Region, 16310, Turkey (Türkiye)
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.
This minimal-risk observational investigation is based solely on the assessment of standard clinical monitoring data obtained during routine sedated endoscopic procedures; no additional procedures or interventions are performed within the scope of the study.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
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 -
Exclusion criteria
Age < 18 years
Unstable cardiovascular or respiratory condition
Requirement for general anesthesia or advanced airway management
Pregnancy
Known hypersensitivity to sedative medications
Refusal or inability to provide informed consent
-
Patients underwent routine combined gastroscopy and colonoscopy performed under standard sedation as part of usual clinical care. No study-related interventions were administered. All monitoring procedures, including the Integrated Pulmonary Index (IPI), were part of standard clinical practice.
Time frame: 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.
Time frame: 0, 3, 5, 10, 15, and 20 minutes during the procedure.
The ability of the Integrated Pulmonary Index (IPI) to predict respiratory deterioration during sedated gastrointestinal endoscopy will be evaluated and compared with conventional respiratory monitoring parameters (SpO₂ and EtCO₂). Diagnostic performance will be summarized using accuracy metrics.
Umran Karaca
Other Gov
Sedation Related Respiratory Deterioration in COPD: Risk Indicators and Predictive Performance of the Integrated Pulmonary Index
Acronym: IPI-COPD
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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