- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03006224
The Effects of Secondary Smoking During One Lung Ventilation
April 4, 2017 updated by: Ahmet Selim Ozkan, Inonu University
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Interventional
Enrollment (Actual)
60
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Sixty patients undergoing lobectomy using one lung ventilation by double lumen tube, ASA physical status 2 and 3.
Exclusion Criteria:
- Recent chest infection, morbid obesity, renal, hepatic and ischemic hearts disease, asthma.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Group S (non smoking and secondary smoking)
I want to see the effects of seconder smoking to intraoperative arterial oxygen tension during one lung ventilation for lobectomy surgery.
|
|
Active Comparator: Group SS (secondary smoking)
I want to see the effects of seconder smoking to intraoperative arterial oxygen tension during one lung ventilation for lobectomy surgery.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
arterial oxygen tension
Time Frame: From beginning of Anesthesia to 1st day of surgery
|
From beginning of Anesthesia to 1st day of surgery
|
arterial carbon dioxide tension
Time Frame: From beginning of Anesthesia to 1st day of surgery
|
From beginning of Anesthesia to 1st day of surgery
|
intraoperative peak airway pressure
Time Frame: during intraoperative ventilation
|
during intraoperative ventilation
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
December 1, 2016
Primary Completion (Actual)
February 1, 2017
Study Completion (Actual)
April 4, 2017
Study Registration Dates
First Submitted
December 22, 2016
First Submitted That Met QC Criteria
December 27, 2016
First Posted (Estimate)
December 30, 2016
Study Record Updates
Last Update Posted (Actual)
April 5, 2017
Last Update Submitted That Met QC Criteria
April 4, 2017
Last Verified
April 1, 2017
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Asozkan-5
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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