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COPD Assessment Test Score and Perioperative Risk in COPD

Prediction of Perioperative Complication Risk Using Chronic Obstructive Pulmonary Disease Assessment Test Score in Chronic Obstructive Pulmonary Disease Patients: A Prospective Cohort Study

Status
Not yet recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07087626
Acronym
COPD
Enrollment
120
Registered
2025-07-28
Start date
2025-08-15
Completion date
2026-02-01
Last updated
2025-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COPD, Preoperative Risk Assessment

Keywords

COPD Assessment Test, COPD, Postoperative Respiratory Complications, Preoperative Risk Assessment

Brief 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 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.

Interventions

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

Sponsors

Erzurum City Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Incidence of Postoperative Respiratory Complications Within 72 HoursWithin 72 hours postoperativelyRespiratory 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.

Secondary

MeasureTime frameDescription
Initiation of Postoperative Oxygen TherapyWithin 72 hours postoperativelyThe 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.
Duration of Postoperative Oxygen TherapyWithin 72 hours postoperativelyThe 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.
Maximum Oxygen Flow Rate Administered PostoperativelyWithin 72 hours postoperativelyThe 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).

Other

MeasureTime frameDescription
Number of Patients Requiring Preoperative Medical OptimizationFrom preoperative assessment to day of surgeryThe total number of COPD patients requiring preoperative medical optimization interventions prior to surgery will be recorded. The outcome will be expressed as the number of patients who received such interventions, including respiratory therapy adjustments, medication changes, or pulmonology consultations.
Types of Preoperative Interventions PerformedFrom preoperative assessment to day of surgeryA categorized record of preoperative medical interventions will be documented, including types such as bronchodilator adjustment, initiation of new medications, and pulmonology consultation. The outcome will be reported as the count of each intervention type (category-wise frequency).

Countries

Turkey (Türkiye)

Contacts

Primary ContactMehmet S Orbak
sercanorbak@gmail.com+ 90 (506) 288 35 34
Backup ContactAhmet Ergün
draergn@gmail.com+ 90 (543) 573 80 02

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026