COMPLICATIONS RELATED CARBOXYHEMOGLOBIN LEVELS IN SECOND HAND SMOKING PEDIATRIC TONSILLECTOMY PATIENTS

September 10, 2013 updated by: Onur Koyuncu, Mustafa Kemal University

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.

Study Overview

Status

Unknown

Conditions

Detailed Description

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

Study Type

Observational

Enrollment (Anticipated)

100

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: onur koyuncu, Assist.Prof
  • Phone Number: 905337744757
  • Email: onurko@yahoo.com

Study Locations

  • Turkey
      • Hatay, Turkey, 31000
        • Recruiting
        • Mustafa Kemal University
        • Contact:
        • Contact:
        • Principal Investigator:
          • Selim Turhanoglu, Prof

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

2 years to 12 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Inclusion Criteria:

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

Description

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.

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

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Correlatin between carboxyhemoglobib levels of the second hand smoking children and postoperative complications and pain
Time Frame: Postoperative 24 hours
Postoperative 24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between carboxyhemoglobin levels of the second hand smoking children and intraoperative bleeding volume
Time Frame: Intraoperative period
Any relation between carboxyhemoglobin and bleeding?
Intraoperative period

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation between carboxyhemoglobin levels and pain of the second hand smoking children
Time Frame: postoperative 24 hours
Does second hand smoking affects pain?
postoperative 24 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mustafa Kemal University

Investigators

  • Study Director: ONUR KOYUNCU, ASSIST PROF, Mustafa Kemal University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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

August 1, 2013

Primary Completion (Anticipated)

September 1, 2013

Study Completion (Anticipated)

September 1, 2013

Study Registration Dates

First Submitted

September 10, 2013

First Submitted That Met QC Criteria

September 10, 2013

First Posted (Estimate)

September 13, 2013

Study Record Updates

Last Update Posted (Estimate)

September 13, 2013

Last Update Submitted That Met QC Criteria

September 10, 2013

Last Verified

September 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 207
  • Onur Koyuncu (Registry Identifier: Onur Koyuncu)

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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