Effects of Passive Smoking on Children During Gastrointestinal Endoscopy

NCT03920046 | Completed

• 1 other identifier: 2018/641
• Study Type: observational
• Target: 518
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Gastro-Intestinal Disorders

Keywords

esophagogastroduodenoscopy; laryngospasm; passive smoking; sedation

Outcome Measures

Primary Outcomes (1)

• laryngospasm ratio

  The prevalence of laryngospasm in sedation applied to endoscopic intervention whose parents smoking.

  an average of 2 hours

Secondary Outcomes (1)

• hypoxia ratio (oxygen saturation < % 90)

  an average of 2 hours

Study Arms (1)

Effects of passive smoking on children

The prevalence of laryngospasm in sedation applied to endoscopic intervention whose parents smoking.

Behavioral: Control Group

Interventions

Control Group BEHAVIORAL

The prevalence of laryngospasm in sedation applied to endoscopic intervention whose parents no smoking.

Effects of passive smoking on children

Eligibility Criteria

• Age: 1 Year - 18 Years
• Sex: all
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Probability Sample

Study Population

Esophagogastroduodenoscopy patients are included in the study

You may qualify if:

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

You may not qualify if:

• Smoker patients

Sponsors & Collaborators

• TC Erciyes University: lead

Study Sites (1)

Sibel Seçkin Pehlivan

Kayseri, Talas, 38039, Turkey (Türkiye)

Location

Related Publications (4)

• Chung HK, Lightdale JR. Sedation and Monitoring in the Pediatric Patient during Gastrointestinal Endoscopy. Gastrointest Endosc Clin N Am. 2016 Jul;26(3):507-25. doi: 10.1016/j.giec.2016.02.004.

  PMID: 27372774 RESULT

• Rodrigo C. The effects of cigarette smoking on anesthesia. Anesth Prog. 2000 Winter;47(4):143-50.

  PMID: 11432181 RESULT

• Tosun Z, Aksu R, Guler G, Esmaoglu A, Akin A, Aslan D, Boyaci A. Propofol-ketamine vs propofol-fentanyl for sedation during pediatric upper gastrointestinal endoscopy. Paediatr Anaesth. 2007 Oct;17(10):983-8. doi: 10.1111/j.1460-9592.2007.02206.x.

  PMID: 17767636 RESULT

• Pehlivan SS, Gergin OO, Bayram A, Altay D, Arslan D, Bicer C, Aksu R. The effect of passive smoking on the laryngospasm rate in children sedated during the esophagogastroduodenoscopy. Saudi Med J. 2022 Mar;43(3):275-282. doi: 10.15537/smj.2022.43.3.20210784.

  PMID: 35256495 DERIVED

MeSH Terms

Conditions

Laryngismus

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Vocal Cord Dysfunction; Laryngeal Diseases; Respiratory Tract Diseases; Respiration Disorders; Otorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Teaching Assistant

Study Record Dates

• First Submitted: April 8, 2019
• First Posted: April 18, 2019
• Study Start: January 2, 2019
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: March 16, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, 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.

Locations

TU (1)