COPDCOPDNCT07087626
COPD Assessment Test Score and Perioperative Risk in COPD
An observational study of COPD and Preoperative Risk Assessment, run by Erzurum City Hospital at 1 site in Turkey (Türkiye).
Trial summary
The goal of this observational cohort study is to evaluate whether the COPD Assessment Test (CAT) score can predict the risk of perioperative respiratory complications in patients aged 40 to 70 years with diagnosed Chronic Obstructive Pulmonary Disease (COPD), undergoing elective surgical procedures lasting no longer… Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- COPD, Preoperative Risk Assessment
- What is being tested?
- Arterial Blood Gas Analysis
- How many people
- 120 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2025to 1 Feb 2027
- How long will I take part?
- 3 Days
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients aged between 40 and 70 years with a diagnosis of stable-stage COPD according to GOLD criteria
Who may be able to join
- Patients aged between 40 and 70 years
- Diagnosed with stable-stage Chronic Obstructive Pulmonary Disease (COPD) according to GOLD criteria
- Scheduled for elective surgical intervention
- Classified as ASA Physical Status II or III according to the American Society of Anesthesiologists (ASA)
- Planned for postoperative follow-up and eligible for at least 72 hours of observation
- Undergoing surgery with an expected duration of at least 150 minutes
- Willing to participate voluntarily in the study
Who cannot join
- Patients younger than 40 years or older than 70 years
- History of COPD exacerbation within the past 4 weeks
- Presence of severe cardiac failure (EF <30%), end-stage renal disease, or active malignancy
- Neurological disorders or cognitive impairments
- Requirement for invasive mechanical ventilation in the preoperative period
- Altered consciousness or any condition preventing completion of forms before anesthesia
- Undergoing surgery with an expected duration longer than 150 minutes
- Unwillingness to participate in the study voluntarily
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Erzurum City Hospital
Erzurum, Yakutiye, 25240
About this study
Official title: Prediction of Perioperative Complication Risk Using Chronic Obstructive Pulmonary Disease Assessment Test Score in Chronic Obstructive Pulmonary Disease Patients: A Prospective Cohort Study
The goal of this observational cohort study is to evaluate whether the COPD Assessment Test (CAT) score can predict the risk of perioperative respiratory complications in patients aged 40 to 70 years with diagnosed Chronic Obstructive Pulmonary Disease (COPD), undergoing elective surgical procedures lasting no longer than 150 minutes.
The main questions it aims to answer are:
Read more
- Is there a statistically significant association between preoperative CAT scores and the incidence of intraoperative and early postoperative respiratory complications in COPD patients?
- Can the CAT score be effectively used as a preoperative risk stratification tool to guide anesthetic and surgical decision-making?
Researchers will compare two patient groups based on CAT scores: those with CAT <10 and those with CAT ≥10 to determine whether higher CAT scores are associated with an increased incidence of perioperative respiratory complications.
Participants will:
- Complete the CAT questionnaire during the preoperative evaluation
- Undergo elective surgery with an expected duration of ≤150 minutes
- Be monitored intraoperatively for bronchospasm, oxygen desaturation, and ventilation difficulty
- Be monitored postoperatively (within the first 72 hours) for hypoxemia, reintubation, bronchospasm episodes, postoperative pneumonia, intensive care unit (ICU) admission, and length of hospital stay
- Have perioperative clinical data collected and analyzed for comparative outcomes between CAT score subgroups
Read the detailed description
Chronic Obstructive Pulmonary Disease (COPD) is a common chronic respiratory disease associated with increased perioperative morbidity and mortality. Surgical procedures in COPD patients often carry higher risks of respiratory complications, making anesthetic management more challenging. The COPD Assessment Test (CAT) is a simple and practical tool developed to assess symptom burden in COPD patients and is being increasingly integrated into clinical practice. While its utility in evaluating disease-related symptoms and quality of life is well documented, the role of CAT score in predicting perioperative respiratory complications remains unclear.
This prospective observational cohort study aims to evaluate whether the CAT score can be used to predict perioperative respiratory risk and support clinical decision-making for anesthesiology and surgical teams. Based on previous estimates, patients with high CAT scores appear to be at greater risk for complications. A total of 120 patients will be enrolled in the study, with 60 patients in each group. Patients will be categorized into two groups based on their CAT scores:
Group 1: CAT <10 (Low symptom burden)
Group 2: CAT ≥10 (High symptom burden)
Patients aged 40-70 years with a diagnosis of stable COPD scheduled for elective surgery lasting no more than 150 minutes will be included. The relationship between CAT score and perioperative respiratory complications will be statistically analyzed.
In the preoperative period (within 24 hours before surgery), data will be collected on demographics (age, sex, BMI, smoking history), comorbidities, surgical type (e.g., thoracic, abdominal, urological), ASA physical status classification, and planned anesthesia technique (general or regional). Arterial blood gas (ABG) samples at rest will be obtained. Additionally, Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) stage, spirometry data (Forced Expiratory Volume in 1 Second (FEV1), Forced Vital Capacity (FVC), FEV1/FVC ratio), and CAT score will be recorded by a pulmonologist.
During the perioperative period, ABG samples will be taken prior to induction and preoxygenation. All patients will receive standardized general anesthesia with full monitoring (Electrocardiogram (ECG), Peripheral Capillary Oxygen Saturation (SpO2), non-invasive blood pressure, capnography). Preoxygenation will be performed for at least 2 minutes. Anesthesia induction protocol includes:
- 1-2 mg IV midazolam (premedication)
- 0.3-0.5 mg/kg IV lidocaine
- 1.5-2.5 mg/kg IV propofol
- 0.6-1.2 mg/kg IV rocuronium
- 1-2 mcg/kg IV fentanyl
After sufficient muscle relaxation, endotracheal intubation will be performed. All patients will be ventilated using volume-controlled ventilation with ideal body weight-based settings: tidal volume 6-8 mL/kg, respiratory rate 10-14/min, Positive End-Expiratory Pressure (PEEP) 3-5 cmH₂O, I:E ratio 1:2, and target End-Tidal Carbon Dioxide (EtCO₂) of 35-45 mmHg. Volatile anesthetics (sevoflurane or desflurane) will be administered at a minimum of 1.3 Minimum Alveolar Concentration (MAC). Intraoperative respiratory events (bronchospasm, desaturation, ventilation difficulty) will be observed and documented. A second ABG sample will be collected 2 minutes after induction.
At the end of surgery, patients will receive 10-15 mg/kg IV paracetamol and 1-2 mg/kg IV tramadol for analgesia. Neuromuscular blockade will be reversed with 2 mg/kg IV sugammadex.
Postoperatively, ABG samples will be taken in the Post-Anesthesia Care Unit (PACU) and again at the 72nd hour. The following respiratory complications will be recorded within the first 72 hours:
- Hypoxemia (SpO₂ <92%)
- Reintubation requirement
- Bronchospasm episodes
- Postoperative pneumonia
- Intensive Care Unit (ICU) admission
- Length of hospital stay (in days)
All data will be collected by anesthesiologists involved in the study.
The primary objective of this study is to evaluate whether the preoperative CAT score can predict postoperative respiratory complications in patients with COPD. The secondary objective is to determine whether patients with high CAT scores require more postoperative oxygen therapy. The tertiary (exploratory) objective is to assess whether patients with higher CAT scores need more extensive medical optimization before surgery and whether the CAT score can serve as a useful guide in preoperative planning.
- Conditions
- COPD, Preoperative Risk Assessment
- Being tested
- Arterial Blood Gas Analysis
- Keywords
- COPD Assessment Test, COPD, Postoperative Respiratory Complications, Preoperative Risk Assessment
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Arterial Blood Gas AnalysisOther
Arterial blood gas analysis will be performed at predefined time points: at rest during the preoperative period, before induction and preoxygenation during the perioperative period, two minutes after induction but prior to intubation, within the first 30 minutes in the PACU during the postoperative period, and at the 72nd postoperative hour in the ward
| Study group | Role | What they receive |
|---|---|---|
| CAT <10 (Low symptom burden) | Patients scheduled for elective surgery, diagnosed with COPD in a stable stage according to the GOLD (Global Initiative for Chronic Obstructive Lung Disease) criteria, and identified as having a low symptom burden (CAT <10) based on preoperative CAT scoring Receives: Other: Arterial Blood Gas Analysis | |
| CAT ≥10 (High symptom burden) | Patients scheduled for elective surgery, diagnosed with COPD in a stable stage according to the GOLD (Global Initiative for Chronic Obstructive Lung Disease) criteria, and identified as having a high symptom burden (CAT ≥10) based on preoperative CAT scoring Receives: Other: Arterial Blood Gas Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Postoperative Respiratory Complications Within 72 Hours
Respiratory complications including hypoxemia (SpO₂ < 90%), reintubation, bronchospasm, pneumonia, or ICU admission will be recorded during the first 72 hours after surgery. Each event will be assessed based on standardized clinical definitions.
The outcome will be reported as the number of patients who experience at least one of the defined complications.
Measured: Within 72 hours postoperatively
Secondary outcomes (3)
Initiation of Postoperative Oxygen Therapy
The requirement for supplemental oxygen within 72 hours after surgery will be recorded. Supplemental oxygen therapy will be initiated based on predefined clinical criteria such as SpO₂ < 92% or signs of respiratory distress.
The outcome will be reported as the number of patients who required oxygen therapy.
Measured: Within 72 hours postoperatively
Duration of Postoperative Oxygen Therapy
The total duration of postoperative oxygen therapy will be recorded for each patient from initiation to discontinuation, within the first 72 hours after surgery. The outcome will be reported as the number of hours per patient receiving oxygen therapy.
Measured: Within 72 hours postoperatively
Maximum Oxygen Flow Rate Administered Postoperatively
The highest flow rate of supplemental oxygen administered to each patient during the first 72 hours after surgery will be documented. The outcome will be expressed in liters per minute (L/min).
Measured: Within 72 hours postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2025
- Study start15 Aug 2025
- Primary completion1 Jan 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COPDStudies 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
- 120 participants (estimated)
- Target duration
- 3 Days
Sponsor and investigators
- Lead sponsor
- Erzurum City Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mehmet Sercan Orbak, Erzurum City Hospital
- Investigators
- Mehmet S Orbak, Principal investigator, Erzurum City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07087626
- Sponsor's protocol ID
- ECH-AR-MSO-01
- Acronym
- COPD
- Status last verified
- May 2026
- First submitted
- 10 Jul 2025
- Last updated
- 1 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Perioperative Complication Risk Using Chronic Obstructive Pulmonary Disease Assessment Test Score in Chronic Obstructive Pulmonary Disease Patients: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT07087626
- Acronym / sponsor ID
- COPD / ECH-AR-MSO-01
- Conditions
- COPD, Preoperative Risk Assessment
- Keywords
- COPD Assessment Test, COPD, Postoperative Respiratory Complications, Preoperative Risk Assessment
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Erzurum City HospitalUniversity, hospital or other
- Study start
- 15 Aug 2025 (actual)
- Primary completion
- 1 Jan 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 28 Jul 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.
The goal of this observational cohort study is to evaluate whether the COPD Assessment Test (CAT) score can predict the risk of perioperative respiratory complications in patients aged 40 to 70 years with diagnosed Chronic Obstructive Pulmonary Disease (COPD), undergoing elective surgical procedures lasting no longer than 150 minutes.
The main questions it aims to answer are:
- Is there a statistically significant association between preoperative CAT scores and the incidence of intraoperative and early postoperative respiratory complications in COPD patients?
- Can the CAT score be effectively used as a preoperative risk stratification tool to guide anesthetic and surgical decision-making?
Researchers will compare two patient groups based on CAT scores: those with CAT <10 and those with CAT ≥10 to determine whether higher CAT scores are associated with an increased incidence of perioperative respiratory complications.
Participants will:
- Complete the CAT questionnaire during the preoperative evaluation
- Undergo elective surgery with an expected duration of ≤150 minutes
- Be monitored intraoperatively for bronchospasm, oxygen desaturation, and ventilation difficulty
- Be monitored postoperatively (within the first 72 hours) for hypoxemia, reintubation, bronchospasm episodes, postoperative pneumonia, intensive care unit (ICU) admission, and length of hospital stay
- Have perioperative clinical data collected and analyzed for comparative outcomes between CAT score subgroups
Detailed description
Chronic Obstructive Pulmonary Disease (COPD) is a common chronic respiratory disease associated with increased perioperative morbidity and mortality. Surgical procedures in COPD patients often carry higher risks of respiratory complications, making anesthetic management more challenging. The COPD Assessment Test (CAT) is a simple and practical tool developed to assess symptom burden in COPD patients and is being increasingly integrated into clinical practice. While its utility in evaluating disease-related symptoms and quality of life is well documented, the role of CAT score in predicting perioperative respiratory complications remains unclear.
This prospective observational cohort study aims to evaluate whether the CAT score can be used to predict perioperative respiratory risk and support clinical decision-making for anesthesiology and surgical teams. Based on previous estimates, patients with high CAT scores appear to be at greater risk for complications. A total of 120 patients will be enrolled in the study, with 60 patients in each group. Patients will be categorized into two groups based on their CAT scores:
Group 1: CAT <10 (Low symptom burden)
Group 2: CAT ≥10 (High symptom burden)
Patients aged 40-70 years with a diagnosis of stable COPD scheduled for elective surgery lasting no more than 150 minutes will be included. The relationship between CAT score and perioperative respiratory complications will be statistically analyzed.
In the preoperative period (within 24 hours before surgery), data will be collected on demographics (age, sex, BMI, smoking history), comorbidities, surgical type (e.g., thoracic, abdominal, urological), ASA physical status classification, and planned anesthesia technique (general or regional). Arterial blood gas (ABG) samples at rest will be obtained. Additionally, Global Initiative for Chronic Obstructive Pulmonary Disease (GOLD) stage, spirometry data (Forced Expiratory Volume in 1 Second (FEV1), Forced Vital Capacity (FVC), FEV1/FVC ratio), and CAT score will be recorded by a pulmonologist.
During the perioperative period, ABG samples will be taken prior to induction and preoxygenation. All patients will receive standardized general anesthesia with full monitoring (Electrocardiogram (ECG), Peripheral Capillary Oxygen Saturation (SpO2), non-invasive blood pressure, capnography). Preoxygenation will be performed for at least 2 minutes. Anesthesia induction protocol includes:
- 1-2 mg IV midazolam (premedication)
- 0.3-0.5 mg/kg IV lidocaine
- 1.5-2.5 mg/kg IV propofol
- 0.6-1.2 mg/kg IV rocuronium
- 1-2 mcg/kg IV fentanyl
After sufficient muscle relaxation, endotracheal intubation will be performed. All patients will be ventilated using volume-controlled ventilation with ideal body weight-based settings: tidal volume 6-8 mL/kg, respiratory rate 10-14/min, Positive End-Expiratory Pressure (PEEP) 3-5 cmH₂O, I:E ratio 1:2, and target End-Tidal Carbon Dioxide (EtCO₂) of 35-45 mmHg. Volatile anesthetics (sevoflurane or desflurane) will be administered at a minimum of 1.3 Minimum Alveolar Concentration (MAC). Intraoperative respiratory events (bronchospasm, desaturation, ventilation difficulty) will be observed and documented. A second ABG sample will be collected 2 minutes after induction.
At the end of surgery, patients will receive 10-15 mg/kg IV paracetamol and 1-2 mg/kg IV tramadol for analgesia. Neuromuscular blockade will be reversed with 2 mg/kg IV sugammadex.
Postoperatively, ABG samples will be taken in the Post-Anesthesia Care Unit (PACU) and again at the 72nd hour. The following respiratory complications will be recorded within the first 72 hours:
- Hypoxemia (SpO₂ <92%)
- Reintubation requirement
- Bronchospasm episodes
- Postoperative pneumonia
- Intensive Care Unit (ICU) admission
- Length of hospital stay (in days)
All data will be collected by anesthesiologists involved in the study.
The primary objective of this study is to evaluate whether the preoperative CAT score can predict postoperative respiratory complications in patients with COPD. The secondary objective is to determine whether patients with high CAT scores require more postoperative oxygen therapy. The tertiary (exploratory) objective is to assess whether patients with higher CAT scores need more extensive medical optimization before surgery and whether the CAT score can serve as a useful guide in preoperative planning.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 3 Days
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CAT <10 (Low symptom burden) | – | Other: Arterial Blood Gas AnalysisPatients scheduled for elective surgery, diagnosed with COPD in a stable stage according to the GOLD (Global Initiative for Chronic Obstructive Lung Disease) criteria, and identified as having a low symptom burden (CAT <10) based on preoperative CAT scoring |
| CAT ≥10 (High symptom burden) | – | Other: Arterial Blood Gas AnalysisPatients scheduled for elective surgery, diagnosed with COPD in a stable stage according to the GOLD (Global Initiative for Chronic Obstructive Lung Disease) criteria, and identified as having a high symptom burden (CAT ≥10) based on preoperative CAT scoring |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients aged between 40 and 70 years with a diagnosis of stable-stage COPD according to GOLD criteria
Key inclusion criteria (7 listed)
- Patients aged between 40 and 70 years
- Diagnosed with stable-stage Chronic Obstructive Pulmonary Disease (COPD) according to GOLD criteria
- Scheduled for elective surgical intervention
- Classified as ASA Physical Status II or III according to the American Society of Anesthesiologists (ASA)
- Planned for postoperative follow-up and eligible for at least 72 hours of observation
Key exclusion criteria (8 listed)
- Patients younger than 40 years or older than 70 years
- History of COPD exacerbation within the past 4 weeks
- Presence of severe cardiac failure (EF <30%), end-stage renal disease, or active malignancy
- Neurological disorders or cognitive impairments
- Requirement for invasive mechanical ventilation in the preoperative period
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 |
|---|---|---|
| Arterial Blood Gas AnalysisArterial blood gas analysis will be performed at predefined time points: at rest during the preoperative period, before induction and preoxygenation during the perioperative period, two minutes after induction but prior to intubation, within the first 30 minutes in the PACU during the postoperative period, and at the 72nd postoperative hour in the ward | Other | CAT <10 (Low symptom burden), CAT ≥10 (High symptom burden) |
Primary outcome
Incidence of Postoperative Respiratory Complications Within 72 Hours
Time frame: Within 72 hours postoperatively
Respiratory complications including hypoxemia (SpO₂ < 90%), reintubation, bronchospasm, pneumonia, or ICU admission will be recorded during the first 72 hours after surgery. Each event will be assessed based on standardized clinical definitions. The outcome will be reported as the number of patients who experience at least one of the defined complications.
3 secondary outcomes
Initiation of Postoperative Oxygen Therapy
Time frame: Within 72 hours postoperatively
Duration of Postoperative Oxygen Therapy
Time frame: Within 72 hours postoperatively
Maximum Oxygen Flow Rate Administered Postoperatively
Time frame: Within 72 hours postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2026.
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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.
Mehmet S Orbak principal investigator
Erzurum City Hospital
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 and Preoperative Risk Assessment, run by Erzurum City Hospital 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 7 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 1 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Mehmet S Orbak (+ 90 (506) 288 35 34, sercanorbak@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Postoperative Respiratory Complications Within 72 Hours (time frame: Within 72 hours postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Jun 2026.