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

NCT07262905 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 100

Last updated 2025-12-04

No results posted yet for this study

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

Interventions

OTHER

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.

Sponsors & Collaborators

  • Umran Karaca

    lead OTHER_GOV

Principal Investigators

  • Füsun Gözen, MD (Anesthesiology) · SBÜ Bursa Yüksek İhtisas Training and Research Hospital, University of Health Sciences (SBÜ)

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-20
Primary Completion
2025-04-20
Completion
2025-07-31

Countries

  • Turkey (Türkiye)

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07262905 on ClinicalTrials.gov