COPD (Chronic Obstructive Pulmonary Disease)IPI-COPDNCT07262905
Risk Indicators and IPI Performance in Sedation-Related Respiratory Deterioration in COPD
An observational study of COPD (Chronic Obstructive Pulmonary Disease) and Endoscopy, Gastrointestinal, run by Umran Karaca at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COPD (Chronic Obstructive Pulmonary Disease), Endoscopy, Gastrointestinal
- What is being tested?
- Sedation Analgesia and Respiratory Monitoring (Integrated Pulmonary Index - IPI)
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Jan 2025to 31 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (≥18 years) with confirmed COPD undergoing elective gastrointestinal endoscopic procedures under sedation analgesia at a tertiary training and research hospital.
Who may be able to join
- 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 -
Who cannot join
- 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
- -
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Bursa Yüksek İhtisas Training and Research Hospital
Bursa, Marmara Region, 16310
About this study
Official title: Sedation Related Respiratory Deterioration in COPD: Risk Indicators and Predictive Performance of the Integrated Pulmonary Index
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.
Read the 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.
- Being tested
- Sedation Analgesia and Respiratory Monitoring (Integrated Pulmonary Index - IPI)
- Keywords
- COPD, Integrated Pulmonary Index, capnography, sedation, endoscopy, hypoventilation
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive, Hypoventilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Sedation Analgesia and Respiratory Monitoring (Integrated Pulmonary Index - IPI) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: 0, 3, 5, 10, 15, and 20 minutes during the procedure.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start20 Jan 2025
- Primary completion20 Apr 2025
- Study completion31 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COPD (Chronic Obstructive Pulmonary Disease)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Umran Karaca
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Umran Karaca, Bursa Yuksek Ihtisas Training and Research Hospital
- Investigators
- Füsun Gözen, MD (Anesthesiology), Principal investigator, SBÜ Bursa Yüksek İhtisas Training and Research Hospital, University of Health Sciences (SBÜ)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07262905
- Sponsor's protocol ID
- BursaYIERH-05
- Other IDs
- 2024-TBEK 2025/01-13
- Acronym
- IPI-COPD
- Status last verified
- Dec 2025
- First submitted
- 16 Nov 2025
- Last updated
- 4 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Deidentified individual participant data will not be shared due to institutional policies and lack of patient consent for data sharing.Study protocol and statistical analysis plan will be available upon reasonable request from the corresponding author.
Publications
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.
PubMed 37331230
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sedation Related Respiratory Deterioration in COPD: Risk Indicators and Predictive Performance of the Integrated Pulmonary Index
- ClinicalTrials.gov ID
- NCT07262905
- Acronym / sponsor ID
- IPI-COPD / BursaYIERH-05
- Keywords
- COPD, Integrated Pulmonary Index, capnography, sedation, endoscopy, hypoventilation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Umran KaracaOther government
- Study start
- 20 Jan 2025 (actual)
- Primary completion
- 20 Apr 2025 (actual)
- Study completion
- 31 Jul 2025 (actual)
- First posted
- 4 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| COPD Cohort | – | Other: Sedation Analgesia and Respiratory Monitoring (Integrated Pulmonary Index - IPI)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (≥18 years) with confirmed COPD undergoing elective gastrointestinal endoscopic procedures under sedation analgesia at a tertiary training and research hospital.
Key inclusion criteria (5 listed)
- 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 -
Key exclusion criteria (7 listed)
- Age < 18 years
- Unstable cardiovascular or respiratory condition
- Requirement for general anesthesia or advanced airway management
- Pregnancy
- Known hypersensitivity to sedative medications
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Other | COPD Cohort |
Primary outcome
Association Between Respiratory Deterioration and COPD-Specific Clinical Risk Indicators
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.
1 secondary outcome
Diagnostic Performance of the Integrated Pulmonary Index (IPI) for Predicting Respiratory Deterioration
Time frame: 0, 3, 5, 10, 15, and 20 minutes during the procedure.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2025.
- Background: PubMed 37331230Karaarslan 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.
- Individual participant dataSharing planned: No. Deidentified individual participant data will not be shared due to institutional policies and lack of patient consent for data sharing.Study protocol and statistical analysis plan will be available upon reasonable request from the corresponding author.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Füsun Gözen, MD (Anesthesiology) principal investigator
SBÜ Bursa Yüksek İhtisas Training and Research Hospital, University of Health Sciences (SBÜ)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COPD (Chronic Obstructive Pulmonary Disease) and Endoscopy, Gastrointestinal, run by Umran Karaca at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Association Between Respiratory Deterioration and COPD-Specific Clinical Risk Indicators (time frame: 0, 3, 5, 10, 15, and 20 minutes during the procedure.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07262905, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Dec 2025.