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Completed

NCT Number: NCT02512770

Hemodynamic and Respiratory Effects of Esophageal Dilation in Children

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.

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Key information

Conditions

Obstruction of Esophagus Airway Obstruction Hemodynamic Instability Respiration Disorders Respiratory Complication Respiratory Insufficiency Respiratory Tract Diseases

Age range

Up to 16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • endoscopy for esaphageal dilatation and control
  • ASA I-III
  • 0-16 year old

Exclusion criteria

  • ASA IV
  • endoscopy for removing foreing body

Treatment and study plan

endoscopic dilatation

Procedure

Primary outcomes

  1. peak inspiratory pressure

    Time frame: at time of endoscopy(0-40minute)

Secondary outcomes

  1. complications ( laryngospasm, bronchospasm, can not be ventilated, decreased Sp02)

    Time frame: at time of endoscopy and after the endoscopy within 2 hours

  2. Sp02

    Time frame: at time of endoscopy and after the endoscopy within 2 hours

  3. pressure levels for target tidal volume

    Time frame: at time of endoscopy(0-40minute)

  4. mean arterial pressure-mmHg

    Time frame: at time of endoscopy(0-40minute)

  5. heart rate-per/min

    Time frame: at time of endoscopy(0-40minute)

Sponsors and collaborators

Lead sponsor

Istanbul University

Other

Collaborators

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

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jul 31, 2015
Registry last updated
Jul 31, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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