COMPLICATIONS RELATED CARBOXYHEMOGLOBIN LEVELS IN SECOND HAND SMOKING PEDIATRIC TONSILLECTOMY PATIENTS

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Mustafa Kemal University
Sponsor:
Information provided by (Responsible Party):
Onur Koyuncu, Mustafa Kemal University
ClinicalTrials.gov Identifier:
NCT01942252
First received: September 10, 2013
Last updated: NA
Last verified: September 2013
History: No changes posted
  Purpose

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.


Condition Phase
Secondhand Smoking
Phase 4

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: COMPLICATIONS OF SECOND HAND SMOKING IN PEDIATRIC TONSILLECTOMY PATIENTS

Resource links provided by NLM:


Further study details as provided by Mustafa Kemal University:

Primary Outcome Measures:
  • Correlatin between carboxyhemoglobib levels of the second hand smoking children and postoperative complications and pain [ Time Frame: Postoperative 24 hours ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Correlation between carboxyhemoglobin levels of the second hand smoking children and intraoperative bleeding volume [ Time Frame: Intraoperative period ] [ Designated as safety issue: Yes ]
    Any relation between carboxyhemoglobin and bleeding?


Other Outcome Measures:
  • Correlation between carboxyhemoglobin levels and pain of the second hand smoking children [ Time Frame: postoperative 24 hours ] [ Designated as safety issue: Yes ]
    Does second hand smoking affects pain?


Estimated Enrollment: 100
Study Start Date: August 2013
Estimated Study Completion Date: September 2013
Estimated Primary Completion Date: September 2013 (Final data collection date for primary outcome measure)
Detailed Description:

Also we want to measure bleeding volume and compare it with the carboxyhemoglobin levels.

  Eligibility

Ages Eligible for Study:   2 Years to 12 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Inclusion Criteria:

-Patients 1-12 years old scheduled for adenotonsillectomy; written informed consent.

Criteria

Inclusion Criteria:

-Patients 1-12 years old scheduled for adenotonsillectomy; written informed consent.

Exclusion Criteria:

  • Active smokers, history of prematurity, bleeding disorders, hemolysis, severe pulmonary disease, home oxygen use, and inpatient hospitalisation≥24 h.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01942252

Contacts
Contact: onur koyuncu, Assist.Prof 905337744757 onurko@yahoo.com

Locations
Turkey
Mustafa Kemal University Recruiting
Hatay, Turkey, 31000
Contact: Onur Koyuncu, Asist.Prof    905337744757    onurko@yahoo.com   
Contact: Selim Turhanoglu, Prof.Dr    905325062988    adat63@gmail.com   
Principal Investigator: Selim Turhanoglu, Prof         
Sponsors and Collaborators
Mustafa Kemal University
Investigators
Study Director: ONUR KOYUNCU, ASSIST PROF Mustafa Kemal University
  More Information

Publications:
Responsible Party: Onur Koyuncu, Asist.Prof.Dr., Mustafa Kemal University
ClinicalTrials.gov Identifier: NCT01942252     History of Changes
Other Study ID Numbers: 207, Onur Koyuncu
Study First Received: September 10, 2013
Last Updated: September 10, 2013
Health Authority: Turkey: Ethics Committee

Keywords provided by Mustafa Kemal University:
Secondhand smoking, pain, postoperative complications

ClinicalTrials.gov processed this record on October 29, 2014