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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).

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
  • Erzurum City Hospital

    Erzurum, Yakutiye, 25240

    Recruiting

Other trials in Turkey (Türkiye)

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.

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 groups in NCT07087626
Study groupRoleWhat 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.

  1. 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)
  1. 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

  2. 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

  3. 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.

  1. First posted28 Jul 2025
  2. Study start15 Aug 2025
  3. Primary completion1 Jan 2027 (estimated)
  4. Study completion1 Feb 2027 (estimated)

Resources

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
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

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.

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