Effects of Passive Smoking on Children During Gastrointestinal Endoscopy

• Sponsor: TC Erciyes University (Other)
• Overall Status: Completed
• CT.gov ID: NCT03920046
• Collaborator: (none)
• Enrollment: 518
• Location: 1
• Actual Duration (Months): 25.9
• Patients Per Site Per Month: 20

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
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.

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: Jan 2, 2019
• Actual Primary Completion Date: Mar 1, 2021
• Actual Study Completion Date: Mar 1, 2021

Arms and Interventions

Arm	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 [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) [an average of 2 hours]

   The prevalence of hypoxia (oxygen saturation < % 90) in sedation applied to endoscopic intervention whose parents smoking.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 1 Year to 18 Years
• Sexes Eligible for Study: All

Inclusion Criteria:

• ASA ( American Society of Anesthesiologists) I- ASA II patients

• Aged 1- 18 Year old patients

Exclusion Criteria:

• Smoker patients

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sibel Seçkin Pehlivan	Kayseri	Talas	Turkey	38039

Sponsors and Collaborators

• TC Erciyes University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Sibel Seçkin Pehlivan, Teaching Assistant, TC Erciyes University
• ClinicalTrials.gov Identifier: NCT03920046
• Other Study ID Numbers: 2018/641
• First Posted: Apr 18, 2019
• Last Update Posted: Mar 16, 2021
• Last Verified: Mar 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Sibel Seçkin Pehlivan, Teaching Assistant, TC Erciyes University: esophagogastroduodenoscopy; laryngospasm; passive smoking; sedation
• Additional relevant MeSH terms: Intestinal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Results

No Results Posted as of Mar 16, 2021