COPD Assessment Test Score and Perioperative Risk in COPD
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40-70
SponsorErzurum City Hospital
About this trial
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
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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)
Disqualifiers
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
Trial population
Patients aged between 40 and 70 years with a diagnosis of stable-stage COPD according to GOLD criteria
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Arterial Blood Gas Analysis
Other interventionArterial 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
Treatment groups
120 Participants
are divided into 2 treatment groupsGroup A: CAT <10 (Low symptom burden)1 intervention
Group B: CAT ≥10 (High symptom burden)1 intervention
Trial outcomes
Primary outcomes
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.
Time frame
Within 72 hours postoperativelySecondary outcomes
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.
Time frame
Within 72 hours postoperatively2
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.
Time frame
Within 72 hours postoperatively3
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).
Time frame
Within 72 hours postoperativelyOther outcomes
1
Number of Patients Requiring Preoperative Medical Optimization
The 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.
Time frame
From preoperative assessment to day of surgery2
Types of Preoperative Interventions Performed
A 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).
Time frame
From preoperative assessment to day of surgerySponsors and contacts
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Source ClinicalTrials.gov