Hemodynamic and Respiratory Effects of Esophageal Dilation in Children

Hemodynamic Instability Clinical Trial

Official title:

Esaphageal Balloon Dilatation in Children: Hemodynamic , Ventilatory Changes and Complications

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02512770
• Other study ID #: 270718
• Status: Completed
• Phase: N/A
• First received: July 26, 2015
• Last updated: July 30, 2015
• Start date: January 2015
• Est. completion date: June 2015

Study information

• Verified date: July 2015
• Source: Istanbul University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Turkey: Ministry of Health
• Study type: Interventional

Clinical Trial Summary

The aim of this study compares hemodynamic and respiratory changes and complications in children who undergoing endoscopy for esophageal balloon dilatation and endoscopy for only control.

Description:

Esophageal strictures in children may develop as a secondary to a surgically repaired esophageal atresia (anastomatic strictures) or as a result of chemical injury after caustic ingestion. Emerging strictures are dilated with balloon catheter at regular intervals.

The possibility of various complications depending on the level of the stenosis during the dilation of esophagus. During Esophageal dilation may be pressed into airways and/or vascular structure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: June 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 16 Years

Eligibility

Inclusion Criteria:

• endoscopy for esaphageal dilatation and control

• ASA I-III

• 0-16 year old

Exclusion Criteria:

• ASA IV

• endoscopy for removing foreing body

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Esophageal Stenosis
• Hemodynamic Instability
• Obstruction of Esophagus
• Respiratory Complication

Intervention

Procedure:
• endoscopic dilatation

Locations

Country	Name	City	State
n/a

Sponsors (5)

Lead Sponsor	Collaborator
Istanbul University	Ayse Cigdem Tutuncu, Fatis Altindas, Guner Kaya, Senol Emre

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	peak inspiratory pressure		at time of endoscopy(0-40minute)	No
Secondary	complications ( laryngospasm, bronchospasm, can not be ventilated, decreased Sp02)		at time of endoscopy and after the endoscopy within 2 hours	No
Secondary	Sp02		at time of endoscopy and after the endoscopy within 2 hours	No
Secondary	pressure levels for target tidal volume		at time of endoscopy(0-40minute)	No
Secondary	mean arterial pressure-mmHg		at time of endoscopy(0-40minute)	No
Secondary	heart rate-per/min		at time of endoscopy(0-40minute)	No