Comparison of Postoperative Pulmonary Complications Between Smokers and Nonsmokers: A Prospective Cohort Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Incidence of Early Postoperative Pulmonary Complications Within 24 Hours After Surgery
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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
结局指标
主要结局
Incidence of Early Postoperative Pulmonary Complications Within 24 Hours After Surgery
时间窗: Within the first 24 hours after extubation
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.
次要结局
- 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)
研究者
mehmet özkılıç
Specialist in Anesthesiology and Reanimation
Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital