Comparison of Postoperative Pulmonary Complications Between Smokers and Nonsmokers

NCT06982911 | Completed

• 1 other identifier: GYEAH-PPC-001
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

This is a prospective observational study designed to evaluate the effect of smoking on early postoperative respiratory symptoms such as cough, airway secretions, and wheezing in adult patients undergoing elective abdominal surgery. Participants will be divided into two groups based on smoking history. The study aims to assess the incidence of minor pulmonary complications-such as increased secretions requiring suctioning, oxygen need, and early respiratory discomfort-within the first 24 hours after surgery. Data will be collected on parameters including secretion volume, oxygen saturation, aspiration frequency, and presence of cough or wheezing. The results will help determine whether active smoking is associated with a higher frequency of early postoperative pulmonary events.

Conditions

Coughing; Post Operative Complications; Wheezing; Smoking, Tobacco

Keywords

Smoking; Pulmonary Secretions; Postoperative Complication; Cough; Abdominal Surgery

Outcome Measures

Primary Outcomes (1)

• Incidence of Early Postoperative Pulmonary Complications Within 24 Hours After Surgery

  The primary outcome is defined as the presence of at least one of the following respiratory findings within 24 hours after extubation: (1) increased airway secretions requiring aspiration, (2) persistent cough, (3) audible wheezing, or (4) oxygen desaturation below 90% on room air. These events will be documented by trained clinical staff using a standardized data collection form. Each patient will be assessed continuously for the first 6 hours and again at the 24th postoperative hour. The incidence of these pulmonary complications will be compared between smoking and nonsmoking patients.

  Within the first 24 hours after extubation

Secondary Outcomes (3)

• Number of Suctions Required for Airway Secretion Clearance Within 6 Hours After Extubation

  Within the first 1 hours after extubation

• Oxygen Desaturation Events Below 90% Within the First 24 Hours After Surgery

  Within the first 24 hours after extubation

• Association Between Assess Respiratory Risk in Surgical Patients in Catalonia (ARISCAT) Risk Score and Postoperative Pulmonary Complications

  Within the first 24 hours after surgery

Study Arms (2)

Smoking Group

Patients with an active smoking history (defined as smoking ≥10 pack-years) undergoing elective abdominal surgery under general anesthesia. This group will be evaluated for early postoperative respiratory symptoms such as increased secretions, cough, and wheezing.

Nonsmoking Group

Patients with no active smoking history (never smoked or quit more than 1 year ago) undergoing elective abdominal surgery under general anesthesia. This group serves as the control and will be assessed using the same early postoperative respiratory criteria.

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients between 18 and 60 years old scheduled for elective abdominal surgery at a tertiary care hospital. Participants include both current smokers and nonsmokers. All patients are American Society of Anesthesiologists (ASA) class I-II-III and free of known chronic respiratory diseases.

You may qualify if:

• Age between 18 and 65 years
• Undergoing elective abdominal surgery under general anesthesia
• ASA physical status I-II-III
• Able to provide informed consent
• Classified as either active smoker (≥10 pack-years) or nonsmoker (never smoked or quit \>1 year ago)

You may not qualify if:

• Diagnosed chronic pulmonary disease (e.g., Obstructive Sleep Apnea, asthma, Chronic Obstructive Pulmonary Disease)
• Acute respiratory tract infection within the past 30 days
• Morbid obesity (Body Mass Index \>35 kg/m²)
• Emergency surgery
• Pregnancy or breastfeeding
• Refusal to participate

Sponsors & Collaborators

• mehmet özkılıç: lead

Study Sites (1)

Gazi Yaşargil Training and Research Hospital

Diyarbakır, 21070, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Cough; Respiratory Sounds; Tobacco Smoking; Smoking; Postoperative Complications

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior; Tobacco Use; Pathologic Processes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Specialist in Anesthesiology and Reanimation

Study Record Dates

• First Submitted: May 13, 2025
• First Posted: May 21, 2025
• Study Start: May 1, 2025
• Primary Completion: July 17, 2025
• Study Completion: July 29, 2025
• Last Updated: August 3, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)