Secondhand SmokingNCT01942252
COMPLICATIONS RELATED CARBOXYHEMOGLOBIN LEVELS IN SECOND HAND SMOKING PEDIATRIC TONSILLECTOMY PATIENTS
An observational study of Secondhand Smoking, run by Mustafa Kemal University at 1 site in Turkey (Türkiye).
Trial summary
The purpose of this study was to determine whether high carboxyhemoglobin level is a risk factor for postoperative adverse events in children exposured to carbon monoxide, especially enviromental tobacco smoke. Read more about this study
- Who is it for?
- Ages 2 to 12 yearsHealthy volunteers can take part
- Conditions the study is for
- Secondhand Smoking
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Aug 2013to Sep 2013
- 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 2 to 12 years
- All sexes
- Healthy volunteers accepted
- Child
Study population: Inclusion Criteria: -Patients 1-12 years old scheduled for adenotonsillectomy; written informed consent.
Who may be able to join
- -Patients 1-12 years old scheduled for adenotonsillectomy; written informed consent.
Who cannot join
- Active smokers, history of prematurity, bleeding disorders, hemolysis, severe pulmonary disease, home oxygen use, and inpatient hospitalisation≥24 h.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Mustafa Kemal University
Hatay, 31000
Onur Koyuncu, Asist.Prof, 905337744757, onurko@yahoo.com
Selim Turhanoglu, Prof.Dr, 905325062988, adat63@gmail.com
About this study
Official title: COMPLICATIONS OF SECOND HAND SMOKING IN PEDIATRIC TONSILLECTOMY PATIENTS
The purpose of this study was to determine whether high carboxyhemoglobin level is a risk factor for postoperative adverse events in children exposured to carbon monoxide, especially enviromental tobacco smoke.
Read the detailed description
Also we want to measure bleeding volume and compare it with the carboxyhemoglobin levels.
- Conditions
- Secondhand Smoking
- Keywords
- Secondhand smoking, pain, postoperative complications
- Medical subject headings
- Pain, Postoperative Complications
What is being measured
The primary outcome is the main question the study is designed to answer.
Correlatin between carboxyhemoglobib levels of the second hand smoking children and postoperative complications and pain
Measured: Postoperative 24 hours
Secondary outcomes (1)
Correlation between carboxyhemoglobin levels of the second hand smoking children and intraoperative bleeding volume
Any relation between carboxyhemoglobin and bleeding?
Measured: Intraoperative period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2013 (estimated)
- Study startAug 2013
- Primary completionSep 2013 (estimated)
- Study completionSep 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Secondhand SmokingStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Mustafa Kemal University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Onur Koyuncu, Mustafa Kemal University
- Investigators
- ONUR KOYUNCU, ASSIST PROF, Study director, Mustafa Kemal University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01942252
- Sponsor's protocol ID
- 207
- Other IDs
- Onur Koyuncu
- Status last verified
- Sep 2013
- First submitted
- 10 Sep 2013
- Last updated
- 13 Sep 2013
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Skolnick ET, Vomvolakis MA, Buck KA, Mannino SF, Sun LS. Exposure to environmental tobacco smoke and the risk of adverse respiratory events in children receiving general anesthesia. Anesthesiology. 1998 May;88(5):1144-53. doi: 10.1097/00000542-199805000-00003.
PubMed 9605672Koop CE. Adverse anesthesia events in children exposed to environmental tobacco smoke: exposure to environmental tobacco smoke and the risk of adverse respiratory events in children receiving general anesthesia. Anesthesiology. 1998 May;88(5):1141-2. doi: 10.1097/00000542-199805000-00001. No abstract available.
PubMed 9605670
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPLICATIONS OF SECOND HAND SMOKING IN PEDIATRIC TONSILLECTOMY PATIENTS
- ClinicalTrials.gov ID
- NCT01942252
- Acronym / sponsor ID
- 207
- Conditions
- Secondhand Smoking
- Keywords
- Secondhand smoking, pain, postoperative complications
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Mustafa Kemal UniversityUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Sep 2013 (estimated)
- Study completion
- Sep 2013 (estimated)
- First posted
- 13 Sep 2013 (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.
The purpose of this study was to determine whether high carboxyhemoglobin level is a risk factor for postoperative adverse events in children exposured to carbon monoxide, especially enviromental tobacco smoke.
Detailed description
Also we want to measure bleeding volume and compare it with the carboxyhemoglobin levels.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 2 to 12 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- Inclusion Criteria: -Patients 1-12 years old scheduled for adenotonsillectomy; written informed consent.
Key inclusion criteria (1 listed)
- -Patients 1-12 years old scheduled for adenotonsillectomy; written informed consent.
Key exclusion criteria (1 listed)
- Active smokers, history of prematurity, bleeding disorders, hemolysis, severe pulmonary disease, home oxygen use, and inpatient hospitalisation≥24 h.
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
Correlatin between carboxyhemoglobib levels of the second hand smoking children and postoperative complications and pain
Time frame: Postoperative 24 hours
1 secondary outcome
Correlation between carboxyhemoglobin levels of the second hand smoking children and intraoperative bleeding volume
Time frame: Intraoperative period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2013.
- Results publication: PubMed 9605672Skolnick ET, Vomvolakis MA, Buck KA, Mannino SF, Sun LS. Exposure to environmental tobacco smoke and the risk of adverse respiratory events in children receiving general anesthesia. Anesthesiology. 1998 May;88(5):1144-53. doi: 10.1097/00000542-199805000-00003.
- Results publication: PubMed 9605670Koop CE. Adverse anesthesia events in children exposed to environmental tobacco smoke: exposure to environmental tobacco smoke and the risk of adverse respiratory events in children receiving general anesthesia. Anesthesiology. 1998 May;88(5):1141-2. doi: 10.1097/00000542-199805000-00001. No abstract available.
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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.
ONUR KOYUNCU, ASSIST PROF study director
Mustafa Kemal University
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 Secondhand Smoking, run by Mustafa Kemal University 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 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: status not confirmed, as of the sponsor's last update on 13 Sep 2013. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact onur koyuncu, Assist.Prof (905337744757, onurko@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Correlatin between carboxyhemoglobib levels of the second hand smoking children and postoperative complications and pain (time frame: Postoperative 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01942252, which also lists 2 linked publications.
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 13 Sep 2013.