Comparison of Postoperative Pulmonary Complications Between Smokers and Nonsmokers

NCT ID: NCT06982911

Last Updated: 2025-08-03

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 70 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-05-01
• Study Completion Date: 2025-07-29

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.

Detailed Description

Cigarette smoking is a well-established risk factor for adverse postoperative outcomes, including respiratory complications. However, many studies have primarily focused on major complications such as pneumonia, reintubation, or prolonged mechanical ventilation, often underestimating early and subtle pulmonary effects of smoking. This study aims to fill that gap by evaluating early minor postoperative pulmonary events-specifically cough, airway secretions, and wheezing-within the first 24 hours after extubation in adult patients undergoing elective abdominal surgery.

The study is designed as a prospective observational cohort conducted in a single tertiary-care hospital. Adult patients (aged 18-65) undergoing elective abdominal surgery under general anesthesia will be included. Participants will be classified into two groups based on smoking history: current smokers and non-smokers. The primary outcome is the occurrence of early minor pulmonary complications, including secretion burden requiring aspiration, Peripheral Oxygen Saturation(SpO₂ ) desaturation (SpO₂ <90%), presence of audible wheezing, and persistent postoperative cough. These events will be documented by trained clinical staff using standardized clinical criteria and data collection forms.

The hypothesis of this study is that active smokers are more likely to develop early minor pulmonary complications within the first 24 hours after surgery compared to non-smokers. The findings will contribute to a better understanding of early perioperative respiratory risk among smoking patients and may support the refinement of risk assessment and preoperative counseling.

Conditions

Coughing; Post Operative Complications; Wheezing; Smoking, Tobacco

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• 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)

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

mehmet özkılıç

OTHER

Sponsor Role: lead

Responsible Party

mehmet özkılıç

Specialist in Anesthesiology and Reanimation

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Gazi Yaşargil Training and Research Hospital

Diyarbakır, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

GYEAH-PPC-001

Identifier Type: -

Identifier Source: org_study_id