Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Passive Smoking on Children During Gastrointestinal Endoscopy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03920046
Recruitment Status : Recruiting
First Posted : April 18, 2019
Last Update Posted : April 18, 2019
Sponsor:
Information provided by (Responsible Party):
Sibel Seçkin Pehlivan, TC Erciyes University

Brief Summary:
To evaluate the effect of passive smoking in children during Gastrointestinal Endoscopy.

Condition or disease Intervention/treatment
Gastro-Intestinal Disorders Behavioral: Control Group

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.

Layout table for study information
Study Type : Observational [Patient Registry]
Estimated Enrollment : 100 participants
Observational Model: Case-Control
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 1 Day
Official Title: Effects of Passive Smoking on Children During Gastrointestinal Endoscopy
Actual Study Start Date : January 2, 2019
Estimated Primary Completion Date : December 1, 2019
Estimated Study Completion Date : January 1, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endoscopy Smoking

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.




Primary Outcome Measures :
  1. laryngospasm ratio [ Time Frame: an average of 2 hours ]
    The prevalence of laryngospasm in sedation applied to endoscopic intervention whose parents smoking.


Secondary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   1 Year to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Sampling Method:   Probability Sample
Study Population
Esophagogastroduodenoscopy patients are included in the study
Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Smoker patients

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03920046


Contacts
Layout table for location contacts
Contact: Sibel Pehlivan 0905052532919 Sibelpehlivan@erciyes.edu.tr
Contact: Sibel Pehlivan, DR 05052532919 Sibelpehlivan@erciyes.edu.tr

Locations
Layout table for location information
Turkey
Sibel Seçkin Pehlivan Recruiting
Kayseri, Talas, Turkey, 38039
Sponsors and Collaborators
TC Erciyes University
Publications of Results:
Layout table for additonal information
Responsible Party: Sibel Seçkin Pehlivan, Teaching Assistant, TC Erciyes University
ClinicalTrials.gov Identifier: NCT03920046    
Other Study ID Numbers: 2018/641
First Posted: April 18, 2019    Key Record Dates
Last Update Posted: April 18, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De- identified individual participant data for all primary and secondary outcome measures will be available.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Analytic Code
Time Frame: Data will be available 36 months of study completion.
Access Criteria: Data accept requests will be reviewed by an external independent Review Panel.Requesters will be required to sign a Data Access Agreement.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sibel Seçkin Pehlivan, TC Erciyes University:
esophagogastroduodenoscopy
laryngospasm
passive smoking
sedation
Additional relevant MeSH terms:
Layout table for MeSH terms
Intestinal Diseases
Digestive System Diseases
Gastrointestinal Diseases