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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 06/15/2021.

Effects of Passive Smoking on Children During Gastrointestinal Endoscopy

Clinicaltrials.gov identifier NCT03920046

Recruitment Status Completed

First Posted April 18, 2019

Last update posted March 16, 2021

Study Description

Brief summary:

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

  • Condition or Disease:Gastro-Intestinal Disorders
  • Intervention/Treatment: Behavioral: Control Group
  • Phase: N/A
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 Design
  • Study Type: Observational [Patient Registry]
  • Actual Enrollment: 518 participants
  • Observational Model: Case-Control
  • Time Perspective: Cross-Sectional
  • Official Title: Effects of Passive Smoking on Children During Gastrointestinal Endoscopy
  • Actual Study Start Date: January 2019
  • Actual Primary Completion Date: March 2021
  • Actual Study Completion Date: March 2021
Groups and Cohorts
Groups/Cohorts 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.
Outcome Measures
  • 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.
Eligibility Criteria
  • Ages Eligible for Study: 1 to 18 Year (Child, Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers:
  • 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

Contacts and Locations
Contacts
Locations

Turkey, Talas
Sibel Seçkin Pehlivan
Kayseri

Sponsors and Collaborators

TC Erciyes University

More Information