NCT07262905Completed
Risk Indicators and IPI Performance in Sedation-Related Respiratory Deterioration in COPD
Sedation Related Respiratory Deterioration in COPD: Risk Indicators and Predictive Performance of the Integrated Pulmonary Index
Source: ClinicalTrials.gov · Last updated 4 Dec 2025
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 100 (actual)
- First submitted
- 16 Nov 2025
- Start date
- 20 Jan 2025
- Primary completion date
- 20 Apr 2025
- Lead sponsor
- Umran Karaca
- Diseases
- COPD
- NCT number
- NCT07262905
What you commit to
- Study type: Observational
- Participants enrolled: 100
- From 20 Jan 2025 to the primary completion date, 20 Apr 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Unstable cardiovascular or respiratory condition
- Known hypersensitivity to sedative medications
Age
- Age \< 18 years
Other
- Requirement for general anesthesia or advanced airway management
- Pregnancy
- Refusal or inability to provide informed consent
- \-
Who the study is looking for
- 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 -
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Bursa Yuksek Ihtisas Training and Research Hospital Coordinator of this site? Confirm its status | Bursa | Turkey (Türkiye) | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.