An observational study in Coughing, Post Operative Complications and Wheezing, sponsored by mehmet özkılıç. Completed at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-08-03.
Sponsored by mehmet özkılıç · Observational
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.
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.
346 studies on the registry are indexed under Cough; 71 are open to participants now.
This study's enrollment of 70 is below the median of 94 across 75 observational studies indexed under Cough.
Browse Cough studies →mehmet özkılıç is the lead sponsor of 2 studies on the registry; none are open to participants now.
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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.
Exclusion Criteria:
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.
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.
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.
Time frame: Within the first 24 hours after extubation
Number of Suctions Required for Airway Secretion Clearance Within 6 Hours After Extubation
This outcome measures the total number of suctioning procedures required to clear airway secretions during the first 6 hours after extubation. Suctioning is performed only when visible or audible secretions are present and is recorded by trained clinical staff using a standardized protocol.
Time frame: Within the first 1 hours after extubation
Oxygen Desaturation Events Below 90% Within the First 24 Hours After Surgery
This outcome tracks the number and duration of oxygen desaturation episodes defined as saturation(SpO₂) falling below 90% on room air within the first 24 hours after extubation. Each event is recorded by trained clinical personnel using pulse oximetry. Desaturation episodes that are corrected by airway maneuvers or supplemental oxygen are noted.
Time frame: Within the first 24 hours after extubation
Association Between Assess Respiratory Risk in Surgical Patients in Catalonia (ARISCAT) Risk Score and Postoperative Pulmonary Complications
The Assess Respiratory Risk in Surgical Patients in Catalonia (ARISCAT) score will be calculated preoperatively for all included patients using seven validated clinical parameters (age, preoperative saturation (SpO2), respiratory infection in the last month, preoperative anemia, surgical incision type, duration of surgery, and emergency status). This score will be evaluated as a secondary outcome to assess its correlation with the incidence of early postoperative pulmonary complications (PPCs). The score will also be included in multivariate analysis models and ROC curve analysis to determine predictive value and optimal cutoff thresholds.
Time frame: Within the first 24 hours after surgery
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Plan to share: No — Individual participant data (IPD) will not be shared because this is a single-center, observational study and no explicit consent for data sharing was obtained from participants. Only aggregate results will be published.
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