COPD Assessment Test Score and Perioperative Risk in COPD

NCT07087626 | Not Yet Recruiting

• 1 other identifier: ECH-AR-MSO-01
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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

Conditions

COPD; Preoperative Risk Assessment

Keywords

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

Outcome Measures

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.

  Within 72 hours postoperatively

Secondary Outcomes (3)

• Initiation of Postoperative Oxygen Therapy

  Within 72 hours postoperatively

• Duration of Postoperative Oxygen Therapy

  Within 72 hours postoperatively

• Maximum Oxygen Flow Rate Administered Postoperatively

  Within 72 hours postoperatively

Other Outcomes (2)

• Number of Patients Requiring Preoperative Medical Optimization

  From preoperative assessment to day of surgery

• Types of Preoperative Interventions Performed

  From preoperative assessment to day of surgery

Study Arms (2)

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

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

Other: Arterial Blood Gas Analysis

Interventions

Arterial Blood Gas Analysis OTHER

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

CAT <10 (Low symptom burden); CAT ≥10 (High symptom burden)

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients aged between 40 and 70 years with a diagnosis of stable-stage COPD according to GOLD criteria

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Erzurum City Hospital: lead

Study Sites (1)

Erzurum City Hospital

Erzurum, Yakutiye, 25240, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Blood Gas Analysis

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Blood Chemical Analysis; Clinical Chemistry Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Investigative Techniques

Study Officials

• Mehmet S Orbak

  Erzurum City Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mehmet S Orbak

CONTACT

+ 90 (506) 288 35 34; sercanorbak@gmail.com

Ahmet Ergün

CONTACT

+ 90 (543) 573 80 02; draergn@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Days
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Anesthesiology Specialist (MD)

Study Record Dates

• First Submitted: July 10, 2025
• First Posted: July 28, 2025
• Study Start: August 15, 2025
• Primary Completion: January 1, 2026
• Study Completion: February 1, 2026
• Last Updated: August 7, 2025

Record last verified: 2025-08

Locations

TU (1)