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

NCT07262905 | Completed

• 2 other identifiers: BursaYIERH-052024-TBEK 2025/01-13
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

COPD (Chronic Obstructive Pulmonary Disease); Endoscopy, Gastrointestinal

Keywords

COPD, Integrated Pulmonary Index, capnography, sedation, endoscopy, hypoventilation

Outcome Measures

Primary Outcomes (1)

• Association Between Respiratory Deterioration and COPD-Specific Clinical Risk Indicators

  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.

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

Secondary Outcomes (1)

• Diagnostic Performance of the Integrated Pulmonary Index (IPI) for Predicting Respiratory Deterioration

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

Study Arms (1)

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.

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

Interventions

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

COPD Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients (≥18 years) with confirmed COPD undergoing elective gastrointestinal endoscopic procedures under sedation analgesia at a tertiary training and research hospital.

You may qualify if:

• 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 -

You may not qualify if:

• 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

Sponsors & Collaborators

• Umran Karaca: lead

Study Sites (1)

Bursa Yüksek İhtisas Training and Research Hospital

Bursa, Marmara Region, 16310, Turkey (Türkiye)

Location

Related Publications (1)

• 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.

  PMID: 37331230 BACKGROUND

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive; Hypoventilation

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Respiratory Insufficiency; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms

Study Officials

• Füsun Gözen, MD (Anesthesiology)

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assoc. Prof. of Anesthesiology and Reanimation

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: December 4, 2025
• Study Start: January 20, 2025
• Primary Completion: April 20, 2025
• Study Completion: July 31, 2025
• Last Updated: December 4, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)