SmokingNCT03006224
The Effects of Secondary Smoking During One Lung Ventilation
A study testing One Lung Ventilation in people with Smoking and Oxygen Deficiencies, run by Inonu University.
Trial summary
Smoking and perhaps secondary smoking is associated with many perioperative and postoperative complications, especially respiratory events. Hypoxemia and airway damage can be associated with secondary smoking. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Smoking, Oxygen Deficiencies
- What is being tested?
- One Lung Ventilation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Dec 2016to 4 Apr 2017
- Phase
- Interventional
- 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 Any age
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Sixty patients undergoing lobectomy using one lung ventilation by double lumen tube, ASA physical status 2 and 3.
Who cannot join
- Recent chest infection, morbid obesity, renal, hepatic and ischemic hearts disease, asthma.
About this study
Official title: The Effects of Secondary Smoking to Intraoperative Arterial Oxygen Tension During One Lung Ventilation in Lobectomy
Smoking and perhaps secondary smoking is associated with many perioperative and postoperative complications, especially respiratory events. Hypoxemia and airway damage can be associated with secondary smoking. The aim of study is to predict the incidence of hypoxemia and airway damage during one lung ventilation for lobectomy.
Read the detailed description
Sixty patients undergoing lobectomy using one lung ventilation by double lumen tube will be included in this study. These patients will be divided into 2 groups. Groups S which will be included non smoking and secondary smoking and group SS which will be included secondary smoking ( smoking near him more than 10 cigarettes per day fore more than 5 years). Intra and postoperative arterial oxygen tension, arterial carbon dioxide tension and intraoperative peak airway pressure will be compared between the two groups.
- Conditions
- Smoking, Oxygen Deficiencies
- Being tested
- One Lung Ventilation
- Keywords
- secondary smoking, one lung ventilation, arterial oxygen tension, lobectomy
- Medical subject headings
- Smoking, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
One Lung VentilationOther
| Study group | Role | What they receive |
|---|---|---|
| Group S (non smoking and secondary smoking) | Active comparator | I want to see the effects of seconder smoking to intraoperative arterial oxygen tension during one lung ventilation for lobectomy surgery. Receives: Other: One Lung Ventilation |
| Group SS (secondary smoking) | Active comparator | I want to see the effects of seconder smoking to intraoperative arterial oxygen tension during one lung ventilation for lobectomy surgery. Receives: Other: One Lung Ventilation |
What is being measured
The primary outcome is the main question the study is designed to answer.
arterial oxygen tension
Measured: From beginning of Anesthesia to 1st day of surgery
arterial carbon dioxide tension
Measured: From beginning of Anesthesia to 1st day of surgery
intraoperative peak airway pressure
Measured: during intraoperative ventilation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Dec 2016 (estimated)
- Study startDec 2016
- Primary completionFeb 2017
- Study completion4 Apr 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SmokingStudies of the same condition, open and under way.
- More trials run by Inonu UniversityThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Inonu University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmet Selim Ozkan, Inonu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03006224
- Sponsor's protocol ID
- Asozkan-5
- Status last verified
- Apr 2017
- First submitted
- 22 Dec 2016
- Last updated
- 5 Apr 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effects of Secondary Smoking to Intraoperative Arterial Oxygen Tension During One Lung Ventilation in Lobectomy
- ClinicalTrials.gov ID
- NCT03006224
- Acronym / sponsor ID
- Asozkan-5
- Conditions
- Smoking, Oxygen Deficiencies
- Keywords
- secondary smoking, one lung ventilation, arterial oxygen tension, lobectomy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Inonu UniversityUniversity, hospital or other
- Study start
- Dec 2016 (actual)
- Primary completion
- Feb 2017 (actual)
- Study completion
- 4 Apr 2017 (actual)
- First posted
- 30 Dec 2016 (estimated)
- 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.
Smoking and perhaps secondary smoking is associated with many perioperative and postoperative complications, especially respiratory events. Hypoxemia and airway damage can be associated with secondary smoking. The aim of study is to predict the incidence of hypoxemia and airway damage during one lung ventilation for lobectomy.
Detailed description
Sixty patients undergoing lobectomy using one lung ventilation by double lumen tube will be included in this study. These patients will be divided into 2 groups. Groups S which will be included non smoking and secondary smoking and group SS which will be included secondary smoking ( smoking near him more than 10 cigarettes per day fore more than 5 years). Intra and postoperative arterial oxygen tension, arterial carbon dioxide tension and intraoperative peak airway pressure will be compared between the two groups.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group S (non smoking and secondary smoking) | Active comparator | Other: One Lung VentilationI want to see the effects of seconder smoking to intraoperative arterial oxygen tension during one lung ventilation for lobectomy surgery. |
| Group SS (secondary smoking) | Active comparator | Other: One Lung VentilationI want to see the effects of seconder smoking to intraoperative arterial oxygen tension during one lung ventilation for lobectomy surgery. |
Who may qualify
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Sixty patients undergoing lobectomy using one lung ventilation by double lumen tube, ASA physical status 2 and 3.
Key exclusion criteria (1 listed)
- Recent chest infection, morbid obesity, renal, hepatic and ischemic hearts disease, asthma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| One Lung Ventilation | Other | Group S (non smoking and secondary smoking), Group SS (secondary smoking) |
Primary outcome
arterial oxygen tension
Time frame: From beginning of Anesthesia to 1st day of surgery
arterial carbon dioxide tension
Time frame: From beginning of Anesthesia to 1st day of surgery
intraoperative peak airway pressure
Time frame: during intraoperative ventilation
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 5 Apr 2017.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
A study testing One Lung Ventilation in people with Smoking and Oxygen Deficiencies, run by Inonu University.
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 1 inclusion and 1 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 5 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
arterial oxygen tension (time frame: From beginning of Anesthesia to 1st day of surgery). The study lists 3 primary outcomes in all. 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 5 Apr 2017.