CoughingMINOPPCNCT06982911
Comparison of Postoperative Pulmonary Complications Between Smokers and Nonsmokers
An observational study of Coughing and Post Operative Complications, run by mehmet özkılıç at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Coughing, Post Operative Complications, Wheezing
- How many people
- 70 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 May 2025to 29 Jul 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Gazi Yaşargil Training and Research Hospital
Diyarbakır, 21070
About this study
Official title: Comparison of Postoperative Pulmonary Complications Between Smokers and Nonsmokers: A Prospective Cohort Study
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.
Read the 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
- Keywords
- Smoking, Pulmonary Secretions, Postoperative Complication, Cough, Abdominal Surgery
- Medical subject headings
- Cough, Respiratory Sounds, Tobacco Smoking, Smoking, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within the first 24 hours after extubation
Secondary outcomes (3)
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.
Measured: 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.
Measured: 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.
Measured: Within the first 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2025
- Study start1 May 2025
- Primary completion17 Jul 2025
- Study completion29 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoughingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- mehmet özkılıç
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, mehmet özkılıç, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06982911
- Sponsor's protocol ID
- GYEAH-PPC-001
- Acronym
- MINOPPC
- Status last verified
- Aug 2025
- First submitted
- 13 May 2025
- Last updated
- 3 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Postoperative Pulmonary Complications Between Smokers and Nonsmokers: A Prospective Cohort Study
- ClinicalTrials.gov ID
- NCT06982911
- Acronym / sponsor ID
- MINOPPC / GYEAH-PPC-001
- Conditions
- Coughing, Post Operative Complications, Wheezing, Smoking, Tobacco
- Keywords
- Smoking, Pulmonary Secretions, Postoperative Complication, Cough, Abdominal Surgery
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- mehmet özkılıçUniversity, hospital or other
- Study start
- 1 May 2025 (actual)
- Primary completion
- 17 Jul 2025 (actual)
- Study completion
- 29 Jul 2025 (actual)
- First posted
- 21 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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)
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of Early Postoperative Pulmonary Complications Within 24 Hours After Surgery
Time frame: 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.
3 secondary outcomes
Number of Suctions Required for Airway Secretion Clearance Within 6 Hours After Extubation
Time frame: Within the first 1 hours after extubation
Oxygen Desaturation Events Below 90% Within the First 24 Hours After Surgery
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
Time frame: Within the first 24 hours after surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2025.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Coughing and Post Operative Complications, run by mehmet özkılıç at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Early Postoperative Pulmonary Complications Within 24 Hours After Surgery (time frame: Within the first 24 hours after extubation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2025.