Risk Indicators and IPI Performance in Sedation-Related Respiratory Deterioration in COPD

NCT ID: NCT07262905

Last Updated: 2025-12-04

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 100 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-01-20
• Study Completion Date: 2025-07-31

Brief Summary

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.

Detailed Description

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.

Conditions

COPD (Chronic Obstructive Pulmonary Disease); Endoscopy, Gastrointestinal

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

COPD Cohort

This cohort includes patients with chronic obstructive pulmonary disease (COPD) undergoing combined gastroscopy and colonoscopy under routine sedation. No study-related interventions are administered. Participants will be classified during analysis based on whether a clinical intervention becomes necessary during the procedure.

Sedation Analgesia and Respiratory Monitoring (Integrated Pulmonary Index - IPI)

Intervention Type: OTHER

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.

Interventions

Sedation Analgesia and Respiratory Monitoring (Integrated Pulmonary Index - IPI)

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

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

-

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Umran Karaca

OTHER_GOV

Sponsor Role: lead

Responsible Party

Umran Karaca

Assoc. Prof. of Anesthesiology and Reanimation

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Füsun Gözen, MD (Anesthesiology)

Role: PRINCIPAL_INVESTIGATOR

SBÜ Bursa Yüksek İhtisas Training and Research Hospital, University of Health Sciences (SBÜ)

Locations

Bursa Yüksek İhtisas Training and Research Hospital

Bursa, Marmara Region, Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

Karaarslan FN, Ozturk ZS, Isik GC, Cevik Y. Value of integrated pulmonary index to predict exacerbation of chronic obstructive pulmonary Disease's severity. Am J Emerg Med. 2023 Sep;71:54-58. doi: 10.1016/j.ajem.2023.05.043. Epub 2023 Jun 8.

Reference Type: BACKGROUND

PMID: 37331230 (View on PubMed)

Other Identifiers

2024-TBEK 2025/01-13

Identifier Type: OTHER

Identifier Source: secondary_id

BursaYIERH-05

Identifier Type: -

Identifier Source: org_study_id