Effects of Passive Smoking on Children During Gastrointestinal Endoscopy

March 15, 2021 updated by: Sibel Seçkin Pehlivan, TC Erciyes University
To evaluate the effect of passive smoking in children during Gastrointestinal Endoscopy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

When the patients and their parents are arrived in the endoscopy unıt about 1 h before the procedure, the anesthetist is obtained a medical history and carried out a physical examination and clinical assesment. Then the parents smoking habits are documented about to detect the magnitude of passive smoking. Endoscopist and anesthesiologist are blinded to the patients passive smoking history. Then the sedation is applied and esophagogastroduodenoscopy procedures performed. Side effects (e.g laryngospasm, coughing) during the study are recorded.

Study Type

Observational

Enrollment (Actual)

518

Contacts and Locations

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

Study Locations

  • Turkey
    • Talas
      • Kayseri, Talas, Turkey, 38039
        • Sibel Seçkin Pehlivan

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

1 year to 18 years (Child, Adult)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Esophagogastroduodenoscopy patients are included in the study

Description

Inclusion Criteria:

  • ASA ( American Society of Anesthesiologists) I- ASA II patients
  • Aged 1- 18 Year old patients

Exclusion Criteria:

  • Smoker patients

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Effects of passive smoking on children
The prevalence of laryngospasm in sedation applied to endoscopic intervention whose parents smoking.
Behavioral: Control Group
The prevalence of laryngospasm in sedation applied to endoscopic intervention whose parents no smoking.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
laryngospasm ratio
Time Frame: an average of 2 hours
The prevalence of laryngospasm in sedation applied to endoscopic intervention whose parents smoking.
an average of 2 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
hypoxia ratio (oxygen saturation < % 90)
Time Frame: an average of 2 hours
The prevalence of hypoxia (oxygen saturation < % 90) in sedation applied to endoscopic intervention whose parents smoking.
an average of 2 hours

Collaborators and Investigators

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

Sponsor

TC Erciyes 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 (Actual)

January 2, 2019

Primary Completion (Actual)

March 1, 2021

Study Completion (Actual)

March 1, 2021

Study Registration Dates

First Submitted

April 8, 2019

First Submitted That Met QC Criteria

April 17, 2019

First Posted (Actual)

April 18, 2019

Study Record Updates

Last Update Posted (Actual)

March 16, 2021

Last Update Submitted That Met QC Criteria

March 15, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2018/641

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

De- identified individual participant data for all primary and secondary outcome measures will be available.

IPD Sharing Time Frame

Data will be available 36 months of study completion.

IPD Sharing Access Criteria

Data accept requests will be reviewed by an external independent Review Panel.Requesters will be required to sign a Data Access Agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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