Hemodynamic and Respiratory Effects of Esophageal Dilation in Children

July 30, 2015 updated by: pinar kendigelen, Istanbul University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: dilatation
esaphageal dilatation group
Procedure: endoscopic dilatation
No Intervention: control
control group ( only endoscopy for control)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
peak inspiratory pressure
Time Frame: at time of endoscopy(0-40minute)
at time of endoscopy(0-40minute)

Secondary Outcome Measures

Outcome Measure
Time Frame
complications ( laryngospasm, bronchospasm, can not be ventilated, decreased Sp02)
Time Frame: at time of endoscopy and after the endoscopy within 2 hours
at time of endoscopy and after the endoscopy within 2 hours
Sp02
Time Frame: at time of endoscopy and after the endoscopy within 2 hours
at time of endoscopy and after the endoscopy within 2 hours
pressure levels for target tidal volume
Time Frame: at time of endoscopy(0-40minute)
at time of endoscopy(0-40minute)
mean arterial pressure-mmHg
Time Frame: at time of endoscopy(0-40minute)
at time of endoscopy(0-40minute)
heart rate-per/min
Time Frame: at time of endoscopy(0-40minute)
at time of endoscopy(0-40minute)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Istanbul University

Collaborators

Ayse Cigdem Tutuncu
Senol Emre
Fatis Altindas
Kaya, Guner, M.D.

Investigators

  • Study Director: Guner Kaya, Prof., Deapartment of Anesthesiology and Intensive Care, Cerrahpasa Medical Faculty,Istanbul University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2015

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

June 1, 2015

Study Registration Dates

First Submitted

July 26, 2015

First Submitted That Met QC Criteria

July 30, 2015

First Posted (Estimate)

July 31, 2015

Study Record Updates

Last Update Posted (Estimate)

July 31, 2015

Last Update Submitted That Met QC Criteria

July 30, 2015

Last Verified

July 1, 2015

More Information

Terms related to this study

Other Study ID Numbers

  • 270718

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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