NCT01942252

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2013

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2013

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
9 days until next milestone

First Submitted

Initial submission to the registry

September 10, 2013

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 13, 2013

Completed
Last Updated

September 13, 2013

Status Verified

September 1, 2013

Enrollment Period

1 month

First QC Date

September 10, 2013

Last Update Submit

September 10, 2013

Conditions

Keywords

Secondhand smoking, pain, postoperative complications

Outcome Measures

Primary Outcomes (1)

  • Correlatin between carboxyhemoglobib levels of the second hand smoking children and postoperative complications and pain

    Postoperative 24 hours

Secondary Outcomes (1)

  • Correlation between carboxyhemoglobin levels of the second hand smoking children and intraoperative bleeding volume

    Intraoperative period

Other Outcomes (1)

  • Correlation between carboxyhemoglobin levels and pain of the second hand smoking children

    postoperative 24 hours

Eligibility Criteria

Age2 Years - 12 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

You may not qualify if:

  • Active smokers, history of prematurity, bleeding disorders, hemolysis, severe pulmonary disease, home oxygen use, and inpatient hospitalisation≥24 h.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mustafa Kemal University

Hatay, 31000, Turkey (Türkiye)

RECRUITING

Related Publications (2)

  • 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.

  • Koop 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.

MeSH Terms

Conditions

PainPostoperative Complications

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Study Officials

  • ONUR KOYUNCU, ASSIST PROF

    Mustafa Kemal University

    STUDY DIRECTOR

Central Study Contacts

onur koyuncu, Assist.Prof

CONTACT

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Asist.Prof.Dr.

Study Record Dates

First Submitted

September 10, 2013

First Posted

September 13, 2013

Study Start

August 1, 2013

Primary Completion

September 1, 2013

Study Completion

September 1, 2013

Last Updated

September 13, 2013

Record last verified: 2013-09

Locations